Good Publication Practice 2022 Update (PDF)

Supplemental Material* DeTora LM, Toroser D, Sykes A, et al. Good Publication Practice (GPP) guidelines for company-sponsored biomedical research: 2022 update. Ann Intern Med. 30 August 2022. [Epub ahead of print]. doi:10.7326/M22-1460 Detailed Table of Contents......................................................................................................... 2 Section A. Publication Types..................................................................................................... 3 Section B. Publication Professional Roles and Professional Development......................... 4 Section C. Ethical Principles: Additional Detail....................................................................... 6 Section D. Publication Steering Committees........................................................................... 6 Section E. Publication Plans...................................................................................................... 8 Section F. Publication Working Groups................................................................................. 11 Section G. Authorship and Contributorship Determination................................................. 12 Section H. Publication Process............................................................................................... 17 Section I. Documentation Guidelines.....................................................................................21 Section J. Expert Reviewers.................................................................................................... 21 References.................................................................................................................................22 * This supplemental material was provided by the authors to give readers further details on their article. The material was not copyedited. © 2022 American College of Physicians Good Publication Practice 2022: Supplement Detailed Table of Contents Section Contents Section A: Publication Types Details the different types of publications Section B: Publication Professional Roles and Identifies roles in the publication profession, team education, and Professional Development policies and procedures Section C: Ethical Principles: Additional Detail Expands on principles presented in the main manuscript Section D: Publication Steering Committees Overview of the process; adds information on patient participation Section E: Publication Plans Overview of contents and considerations Section F: Publication Working Groups Formation, roles, and responsibilities for various contributors to a publication Section G: Authorship and Contributorship Considerations and process for determining authorship and contents Determination for authors agreements Section H: Publication Process Details the process and responsibilities for producing an individual publication, including review and approval Section I: Documentation Guidelines Details necessary documentation Section J: Expert Reviewers List of expert reviewers DeTora LM, et al. Ann Intern Med. 2022 2 Good Publication Practice 2022: Supplement Section A. Publication Types Scientific Conference Presentations Scientific conferences generally require abstract Primary and Secondary Publications submission prior to acceptance as a presentation or Primary Publications poster. Abstracts may be refereed (7) or peer reviewed and published. Presentations vary in terms of length Primary publications are original peer-reviewed articles and the number and type of visual aids (such as slides, reporting the primary outcome measures or endpoints audio, video) that may be used. of a clinical trial or other research study. Primary Encore presentations may be permitted by some publications may include additional outcomes or conferences and should reference the original abstract. endpoints (e.g., secondary or exploratory endpoints). Encore presentations should address distinct audiences Of note, publications of study design, intermediate (e.g., different medical specialties or conferences in analyses, and datasets may appear before primary different countries or languages) and/or meet specific publications and, if so, should be referenced therein (32). medical and scientific needs (7). Secondary Publications Other Publication Types Articles reporting only secondary or exploratory Methodology articles describe novel study designs. endpoints, subgroup analyses, or post-hoc analyses Such publications should follow the applicable of a clinical or other research study are considered guidelines (e.g., EQUATOR Network guidelines ) secondary publications. for the type of research reported. Secondary articles should address clinical or scientific Book chapters should meet the same standards needs to avoid unnecessary splitting of datasets (also for rigor and scientific accuracy as peer-reviewed known as “salami slicing” or data slicing) (38). Except journal articles. in situations of pressing scientific or medical urgency, Most other publication types are rare in company- secondary publications should be submitted to peer- sponsored research settings. For instance, case reports reviewed journals only after primary publications. should be prepared by persons directly responsible Secondary publications should cite or refer to the for patient care, and expert consensus statements are primary publication. often written directly by the experts. Letters to the editor may be written in response to an Reviews and Meta-Analyses article or letter. A letter to the editor should be initiated Review articles require a clear scientific or medical by a sponsor employee only to correct misinformation. justification. Reviews may be based on expert opinion, Should a letter to the editor be solicited from a sponsor systematic searching in databases, or meta-analyses of employee in response to questions or concerns, care previously published data (17). Care should be taken should be taken to maintain a neutral scientific tone, to ensure that reviews are original, objective, and limit remarks to corrections and clarifications, and nonpromotional. Some groups, such as the Cochrane include all relevant disclosures. Collaboration (39), will not permit commercial funding A robust scientific or medical rationale should exist to of systematic reviews. justify company funding of journal supplements, for example, thematic issues (42). Systematic literature reviews and meta-analyses should follow an accepted guideline such as those listed by the Enhanced Content and Plain Language EQUATOR Network (40, 41). In cases where protocols Summaries for such reviews may be registered (e.g., PROSPERO), Any publication might be augmented by enhanced they should be. content, including a plain language summary (PLS) Narrative reviews are generally invited to summarize or lay summary, presented in various formats such as scientific information for a specific audience, serve text, video, audio, podcast, or infographic (43). The an educational need, or express a medical opinion. enhanced content must be consistent with that of the Given the potential for bias, opinion-based narrative underlying publication and must not be promotional in reviews should be identified as expert opinion and language, tone, or style. Of note, a PLS follows plain- undertaken only by qualified experts for reputable language principles and may serve many audiences, while lay summaries of publications are intended for journals. The submission of opinion pieces regarding nonexperts (43, 44). A well-designed PLS may serve company-sponsored clinical research by company both functions (45). The structure and content of authors should be limited to requests by reputable enhanced content, including PLSs, may vary (45–49). journals, conferences, regulatory groups, or GPP endorses enhanced content if it is developed professional societies. following the same ethical and quality principles as the main publication. DeTora LM, et al. Ann Intern Med. 2022 3 Good Publication Practice 2022: Supplement We recommend that a text-based PLS be prepared for help authors develop publications (50). Emerging any clinical trial publication that follows the CONSORT evidence suggests that professional medical writers guidance (i.e., for both investigational and marketed enhance publication quality; publications developed products), and for any other publication of clinically with medical writers as collaborators has been relevant information about any currently marketed associated with a reduced risk for retractions due to product. Ideally, a PLS should appear with every misconduct (50, 51). The AMWA-EMWA-ISMPP Joint biomedical publication, keeping in mind the audiences Statement on the Role of Professional Medical Writers for the information being presented (45). provides helpful information for working with medical Whenever possible, a PLS should be published in the writers (26). same journal as the original publication and should Visual artists and designers can contribute to the undergo peer review. PLSs should be indexed (e.g., clarity of tables, figures, posters, presentations, and in PubMed) and be fully discoverable, either on their infographics. own or as part of the publication and be available as Professional Development open access. Publication professionals and professional medical A standalone PLS abstract or article may present writers should engage in professional development, information from one or more publications and should for example by attending events run by local, be prepared following GPP (including peer review, if regional, national, and international professional possible). The original research should be cited and organizations. Training programs are provided by relevant permissions must be obtained. Clinical trial various organizations (e.g., ISMPP, AMWA, EMWA, or other unique registry identifiers (as appropriate and Drug Information Association) (8, 12, 13), and for the type of information being reported) should certification programs with enforceable codes of be included and the original publication cited and/ conduct have been introduced (52–55). or linked to (48). Other types of enhanced content may be included if needed (48). Sharing Best Practices Publication professionals should encourage honest Section B. Publication working relationships and professional integrity. Publication professionals should share best practices Professional Roles and with their teams on a regular basis, and at critical times Professional Development during program and publication development (See Supplement Table 1 for an example). For instance, Professional Roles information regarding publications may be needed Publication professionals may be employed by in informed consents and protocols. Opportunities companies, medical communications agencies, or for team education might include sharing information other institutions. Company-employed publication about working with patients and patient advocates. professionals preserve the integrity of the publication process and advise authors, writers, internal reviewers, Developing Publications Policies and publication working groups, and steering committees Procedures (SCs). They generally oversee the publication plan A documented policy and/or SOP should guide the and the overall quality of publications and ensure production, review, and documentation of publication that appropriate documentation is collected (See plans and publications (6). A policy or SOP should Section I). These professionals often manage include methods for arbitration, mediation, and the publication budget and mediate or manage resolution of conflicts. The scope and breakdown (or professional relationships. Publication professionals granularity) of contents for policies, SOPs, and working may also educate team members on various aspects instructions for publications should be generally of publication management, ethics, and development consistent with the usual practices within a given as well as standard operating procedure (SOP) organization. development. Agency publication professionals may We recommend this version of GPP as the basis for be contracted to perform services that would typically publications policies, SOPs, and working instructions. be done by an in-house publication professional, as Companies may opt to develop separate policies well as additional services, such as writing, editing, and for company-initiated and investigator-initiated publication plan management. publications. Policies and SOPs for team training Properly trained and experienced medical writers can regarding publication practices may also be useful. DeTora LM, et al. Ann Intern Med. 2022 4 Good Publication Practice 2022: Supplement Supplement Table 1.Team Education: Essential Events Company policies may refer to ICMJE but should and Timings for Clinical Research Publications defer to guidelines (such as authorship criteria) for specific journals and conferences so as not to impede Stage/Event Explanation publication in any relevant specialty areas. Initiating a A publication professional should Publication policies may cover topics such as open Clinical Program inform the project team about access, data sharing, enhanced content and/or social publication policies. media use, payment of open-access or page fees, If applicable, language may be funding for conference attendance, use of preprint suggested for study protocols to servers, patient involvement in publications, and ensure alignment with GPP, ICMJE posting of presentation materials in public repositories recommendations (35), and relevant or other websites. guidelines from the EQUATOR Network (e.g., CONSORT) (17, 18). Publication policies should also specify that colleagues serving in certain commercial job roles (e.g., marketing, Investigators’ A brief overview of the publication market access, business strategy) should not participate Meeting policy and the author and SC selection in publication planning, content development, review, process is appropriate. or approval. Publication SC For new committee members, pertinent Launch/ policies, roles, and procedures should Standard Operating Procedures and/or Publication be reviewed. Working Instructions Kick-Off SOPs and/or working instructions should describe Ad Hoc Updates to policies, SOPs, and working practices for SCs and publication working groups, instructions should be communicated including publication planning; author agreements; in writing. If training is anticipated to be publication development, review and approval needed, the contents of such training (including which functional areas should perform also should be prepared by the time of reviews); quality control steps; acknowledgments; that communication so that teams may submission and post-submission activities (e.g., schedule such training at their earliest convenience. An annual check-in with responding to peer review comments and finalizing publication SCs may be helpful to page proofs). The process for enhanced content assess training needs. development, review, and approval should be included CONSORT = Consolidated Standards of Reporting Trials; or referenced in the publication SOP. GPP = Good Publication Practice; ICMJE = International Committee of When developing SOPs, health economics and Medical Journal Editors; SC = steering committee; outcomes research (HEOR), and real-world evidence SOP = standard operating procedure. (RWE) publications should be considered; inherent differences between research in different areas such Policies as biologics, devices, vaccines, laboratory research, and methods development might also need to We recommend developing a unified publication be addressed. In some cases, SOPs or working policy to cover all biomedical publications. Policies for instructions by area, discipline, geographic region, or publication planning and development should specify, therapeutic area may offer added granularity, address at a minimum: legal differences, or specify the required subject matter Ethical principles, including a statement about data expertise for review and approval. While an ideal integrity situation is to have unified policies and procedures, Timing for overall publication planning and separate working instructions might be developed to publishing individual datasets relative to data list necessary reviewers for publications of different availability, in line with applicable laws or regulations types of research or timelines for review of abstracts or presentations versus manuscripts. Principles for scientific review and approval, including the role of reviewers and approvers Review, Approval, and Updates Policies, SOPs, and working instructions should be The need for auditable documentation reviewed and approved consistent with company best The role of intellectual property (IP) or other practice. Regular evaluation is recommended to keep legal review these documents up to date. DeTora LM, et al. Ann Intern Med. 2022 5 Good Publication Practice 2022: Supplement Section C. Ethical Principles: about specific products, company-sponsored research about those products, or biomedical publications Additional Detail of such research. Social media posting by company Commitment to Peer-Reviewed Publication employees about content related to specific products Publicly posting summaries of clinical trial results should remain limited to company-sponsored on trial registries (e.g., ClinicalTrials.gov or EudraCT accounts, following appropriate internal procedures [56, 57]) does not preclude the ethical obligation to (65). Academic and other researchers not employed by attempt to publish complete methods and findings sponsor companies, similarly, should follow any social in peer-reviewed publications (33, 58). Most scientific media guidelines set by their employers. Company posters, presentations, preprints, and many conference or communications agency employees should abstracts are not formally peer-reviewed (59). Therefore, not encourage academic authors to make social presentations at conferences or the appropriate use media postings about specific company-sponsored of preprint servers does not substitute for publication publications or presentations that report data about in a peer-reviewed journal, even if an abstract has specific products (59). been published. With appropriate permissions, company websites Materials where peer review and formal review for may post peer-reviewed publications and published balance (or lack of bias) were not performed, and abstracts. Links to the digital object identifier (DOI) publications describing investigational drugs given for for open-access or free-to-access works may also unapproved indications should be used and shared be helpful. only for scientific exchange. Additional Significant Considerations Publications as scientific exchange Consistent with accepted guidelines for biomedical Medical and scientific publications are forms of publications (3), certain practices should be avoided scientific exchange that should focus on the needs of as a matter of course. Ghost management refers to the researchers, as well as healthcare providers who work undisclosed (or inadequately disclosed) involvement with patients and caregivers (60–62). Maintaining a focus on scientific exchange helps ensure publication of company employees in the planning, review, or integrity and provides “safe harbor” protections for writing of publications (66, 67). authors and sponsors (63, 64). Scientific exchange Commercial concepts, such as “share of voice”, and the here is defined as sharing objective, balanced medical need to outdo competitors regarding the number of or scientific information in settings such as scientific publications or citations, may encourage other poor conferences or peer-reviewed journals. practices and should be avoided. All research involving human participants should include a statement about the Institutional Review Section D. Publication Steering Board and/or Independent Ethics Committee review and informed consent procedure. Publications of Committees laboratory or other nonclinical (e.g., animal) research Publication SCs may be formed to advise publication should also contain an ethics statement. Anonymized planning for one or more studies. A publication surveys and other research that were legally exempt SC is recommended for each clinical program or from full review should be identified as such and the research program and for large-scale clinical trials specific regulation cited. Patient confidentiality should that are expected to generate multiple peer-reviewed be protected. journal articles. A separate SC is not required for each Special Considerations for Communicating publication or study, and for a study expected to result with the Public in only one manuscript, a publication working group Social media postings about publications of company- may fulfil the functions of the SC. sponsored research data are available to the Publication SCs also may be formed by product, general public. Therefore, such communications can indication, or for a specific region or scientific specialty appear promotional, even if they are intended to be area (e.g., HEOR studies, device studies, vaccines). If informational. In the context of regulated research, guidance from a similar patient group may be needed by compliance must be maintained regarding label multiple publication SCs, a separate patient publication indications and pharmacovigilance obligations. SC may be formed; a publication professional may Individual employees of sponsors, companies, or facilitate communication across relevant groups (68, medical communications agencies should not use 69). An overview of the Publication Steering Committee personal social media accounts to post information Lifecycle is presented in Supplement Figure 1. DeTora LM, et al. Ann Intern Med. 2022 6 Good Publication Practice 2022: Supplement Supplement Figure 1. Suggested Life Cycle of a Publication Steering Committee Committee formed by sponsor Charter/guidance or publication professional document developed When? Before data are available Describing the roles & Who? Internal & external stakeholders, responsibilities of the countries including a chair/co-chairs Publication roles agreed Committee meets Study investigators informed Roles (if any) on presentations & At the start: for initial planning of Provided with information on the committee publications should be agreed, proposed presentations & publications membership & its responsibilities e.g., as authors, contributors, As data become available: writers, or reviewers at least annually to update the plan Publication working Writing and review Publication/presentation group formed See Publication Process To ensure appropriate & transparent authorship decisions are made Committee disbanded When? Once all deliverables overseen by a specific plan are complete How? Should be formalized in writing Responsibilities In the case of alliances between multiple sponsors, a The publication SC is responsible for ensuring that the member of each alliance partner should be involved in following activities occur: forming the SC and selecting the membership, unless The publication plan is completed and, as needed, otherwise specified in an alliance agreement. coordinated with additional relevant publication Once all deliverables overseen by a specific publication plans, based on the scope of the SC’s remit SC are completed, the committee should disband; this Auditable documentation is maintained should be formalized in writing (e.g., meeting minutes). (See Section G) Membership Clinical trial teams and investigators are informed of SC membership should be optimized for the needs and relevant publication policies and kept up to date on complexity of the research to be published and may the progress of publication activities change over time. As with any committee, the number Investigators and other researchers have an of participants should be limited to ensure efficiency. opportunity to opt in or out of publication working groups, investigator groups listed in manuscripts, or Inclusivity should be considered in forming SCs. Care group authorship (“author groups”). should be taken to have a balance of committee members to represent geographic regions, demographic Publication working groups, and any additional characteristics, and job roles, with attention to the appropriate working groups (e.g., authorship locations in which research was performed (3). adjudication, patient advocacy) are formed and composed of appropriate membership SC membership should, where possible, include study investigators as well as sponsor employees or Suitable replacement SC members are identified, as needed contractors involved in study conduct. We recommend including scientists, clinicians, or statisticians with Formation and Ending expertise applicable to the study, methods, product, A sponsor employee with appropriate research or condition. A publication professional should also responsibility (e.g., a clinical study lead) or a publication be included. professional should form the SC before data are available It is not permissible to include sponsor colleagues (e.g., prior to database lock) for the first applicable whose primary job functions are focused on commercial publication to be managed (See Supplement Figure 1). activities such as marketing or business strategy. DeTora LM, et al. Ann Intern Med. 2022 7 Good Publication Practice 2022: Supplement SC Members as Authors As applicable, the publication policies and SOPs of all While some SC members may qualify as authors of one alliance members should be reflected in the charter. or more publications, SC members are not required to For clinical trials, the charter and names of SC serve as authors. Therefore, it is permissible to include members should be provided to investigators, with colleagues who do not meet authorship requirements. an appropriate contact, such as the chairperson. Patients as Steering Committee Members Ideally, this information will be presented at the investigator meeting. Patients, caregivers, and patient advocates may be included in publication SCs, a practice especially Meetings and Communication encouraged for committees overseeing the The publication SC should meet at least annually and as publications about rare or chronic conditions (69). data become available to discuss publication activities Additional Considerations and update the publication plan. A representative from each publication working group should provide For SCs with more than a few members, a project status updates before or during these meetings. manager might be helpful in tracking activities. An Coordination by the SC is recommended with groups authorship adjudication working group of three to four that manage regional publication plans or publications members might also be useful. of other scientific work, as applicable. For SCs that support large publication plans that are Meeting minutes and tracking documents should regularly updated, members may leave the committee. be communicated to relevant stakeholders (e.g., the A process for nominating new members might be clinical trial team or program team for publications of included in a charter. clinical data) and maintained in an auditable format. Alliances Colleagues whose primary job functions are in sales, For alliance programs, publication SCs should include marketing, or other business functions may attend members from all alliance partners unless agreements informational meetings and receive status updates between the alliance partners specify otherwise. If not on publication plans. Such colleagues may also specified in the alliance agreement, responsibilities of communicate their plans for meeting attendance and the alliance partners with regard to publications should special programs to aid scheduling time with experts be specified in the SC charter. Designating one alliance and opinion leaders, who may be publication authors. partner as the accountable lead for publications will streamline publications activities. Section E. Publication Plans No minimum number of authors or publication SC Publication plans help ensure that research is members is required per alliance partner. Duplicate published and presented in a responsible, ethical, representation for all roles and functional areas is not and timely manner (see Supplement Table 2). Ideally, recommended; however, review may be necessary a publication plan will include all publications for a within each alliance partner organization, as agreed to specific product or therapeutic area, timelines, and among the parties. resources (14, 24, 70, 71). Special considerations for An ad hoc alliance subteam may be formed within an the publication plan are presented in Supplement SC to adjudicate any issues that may arise. Table 3. Chairperson Principles A SC should choose a chairperson. A sponsor lead Studies and Data That Should be Published (e.g., clinical lead or publication professional) may be We encourage the publication of all clinical trial results, useful. In alliance settings, a SC lead may be needed including noninterventional studies. Minimally, primary from each sponsoring organization. and key secondary findings from all Phase 2 and 3 clinical Charter trials should be submitted for publication in a peer- The SC chairperson should ensure that each reviewed journal, regardless of whether the findings committee member receives a charter that outlines are positive, negative, or inconclusive, or whether the their responsibilities and the general structure and studied intervention is investigational, licensed, or governance of the committee, including consensus has been discontinued or withdrawn from the market building. If an authorship adjudication working (1, 25, 33). For marketed products, publications of all group is needed, its work and membership should clinical studies, nonclinical studies, health economics, be described in the SC charter. The charter should be and outcomes research are encouraged. completed before any work is initiated on publications. Not every study merits a separate publication; The charter should include an end point for individual manuscripts may combine studies that on their own participation as well as the committee itself. might not be sufficient for a dedicated publication. DeTora LM, et al. Ann Intern Med. 2022 8 Good Publication Practice 2022: Supplement Supplement Table 2.Principles for Publication Plans Auditable publication plans are developed in compliance with GPP and sponsor policies, as applicable All clinical trial data and other relevant research (including regional studies) are reflected in the publication plan Primary publications reporting prespecified primary endpoints or objectives are prioritized over secondary publications and reviews, and any background information needed to contextualize clinical data (e.g., new methods or techniques) is published before clinical data All publication components, including plain language summaries (PLSs) and enhanced content (and technical support needed to produce them) are included in planning and budgeting Scientific and clinical needs are identified for planned publications of secondary or subgroup analyses, pooled data analyses, or systematic reviews Journal and conference selection is appropriate and realistic; submission opening dates and deadlines for relevant conferences should be aligned with anticipated data availability; open-access and free-to-access options are prioritized Encore publications, translations, and re-publications are included only to meet specific scientific and medical needs and/or reach audiences who lack access to the original publication (which should be cited) Authors are notified in a timely manner of their roles and responsibilities, and appropriate working groups are formed to support publication development Authors have access to relevant study data Datasets are generally consistent across publications for a single study (e.g., abstract, poster, manuscript) and trial identifiers are used in all publications Journal and conference embargoes are respected If manuscripts describing a clinical trial dataset that Review and Approval of Publication Plans meets quality and ethical guidelines for publication The publication plan should be reviewed and approved have been rejected multiple times (for instance, based consistent with applicable policies and procedures at on inconclusive or negative results), such data may still the sponsoring organization and by publication SC be included in applicable peer-reviewed review articles members (if applicable). and meta-analyses. Such data should be identified as If multiple SCs oversee publications within the same not previously published. plan, then review and approval responsibilities should For investigational products, publications of data from be divided logically. studies other than clinical trials also may be necessary for transparency or to inform clinical decision making. Regional studies should not be overlooked in publication planning. DeTora LM, et al. Ann Intern Med. 2022 9 Good Publication Practice 2022: Supplement Supplement Table 3. Special Considerations for the Publication Plan Consideration Explanation Timing of Publications The World Health Organization suggests submitting the main findings of clinical trials to an and Data open-access peer-reviewed journal within 1 year of trial completion (72). To allow for conference presentation, primary clinical study data for licensed products should be submitted to a journal within 18 months of study completion. For investigational products, study data should be submitted within 12 months of product approval or 18 months of product discontinuation (33). Providing Authors with Sponsors must provide authors and other contributors with relevant aggregated study data, Access to Data consistent with patient confidentiality (per local requirements), before work on a publication begins, or as soon as data become available (3). Replicate or Care must be taken to avoid the appearance of duplicate or redundant publication. Confirmatory Studies Originality All publications included in a publication plan should represent original work unless specifically designated as permissible re-publications or encore presentations by publishers or conferences. If copyright of published or presented content is held by the publisher, authors may need permission to reuse their own work. Embargoes Embargoes set by journals, conferences, or other media must be respected. Social media posting and press releases should be made by appropriate persons and groups and not violate embargoes. Publicly listed companies may have to disclose important information on clinical trials to investors ahead of submission to conferences or journals. Publication professionals should coordinate with responsible communicators to ensure that appropriate communications are made, and inappropriate communication avoided (73). Feasibility Publication planning should account for the ability of authors and other contributors to meet timelines, especially when multiple publications are being developed in parallel. Adequate time is needed for proofreading, fact checking, data verification, quality assurance, and formatting, as well as peer review and revisions. Preprint Server Posting Preprints serve an important function in many research areas and may be helpful for refining research questions and analyses (74). Preprints may be indexed and/or assigned DOIs (59). Journal policies regarding preprints vary; some journals consider preprints prior publication and some do not permit preprints as citations (59). Preprints generally are not peer reviewed (3); however, some journals routinely post accepted versions of manuscripts following peer review. Since preprints generally are not peer reviewed, they should not be a routine element of publication planning or data dissemination for company-sponsored clinical trial data. Urgent public health needs may necessitate the use of preprints for clinical trial data in limited circumstances to collect feedback or share critical information (3). In such cases, the preprint should meet the same standards for rigor, completeness, and ethics as a peer-reviewed publication. All authors must agree to posting on a preprint server. Preprints should not be confused with platforms using post-publication peer review and indicating review status/progress such as eLife and F1000Research (75, 76). Following ICMJE recommendations, preprints must be clearly labelled as preliminary reports and as not peer reviewed. Preprints should include any applicable trial or study registry numbers (3). Each iteration of a preprint should be date- and time-stamped and no updates to the content of the preprint should occur after a peer reviewed publication is published. If it is not possible to remove the preprint after such publication, the preprint should be updated to state that a peer-reviewed article has been published and linked to the published manuscript (59). Publication Companies or other sponsors may reimburse reasonable publication- or presentation-related Development Costs out-of-pocket expenses, such as travel and accommodation, incurred by presenting authors. These and Reimbursement reimbursements should be reasonable and not overly restrictive. Manuscript submission fees, open-access fees, page or article processing charges, and color figure fees are all reasonable expenditures. Additional costs may include third-party activities such as statistical analysis, professional writing or editing, graphic design, or video production. Reprints may be a reasonable cost. Appropriate processes for vendor selection and obtaining fair market pricing should be followed. DeTora LM, et al. Ann Intern Med. 2022 10 Good Publication Practice 2022: Supplement Supplement Table 3. Special Considerations for the Publication Plan (Cont’d) Consideration Explanation A Note on Disclosures of Any payment, or transfer of value, that will be made to, or on behalf of, a healthcare provider Publication Development author that will be reported under any national or regional transparency law should be Costs and Reimbursement disclosed to the author in advance of the transfer of value and with sufficient time for the author to opt out. Disclosure of financial support for any publication activity received by authors and contributors must comply with applicable laws and regulations (e.g., The Sunshine Act ), in addition to company, institutional, journal, and conference policies. Study Registration and Consistent with regulations and guidelines (25) and ICMJE recommendations (3), many journals Public Posting of Data and conferences require registry of clinical trials and other studies prior to study initiation. Clinical trials should appear on a public online registry (e.g., ClinicalTrials.gov, EudraCT, Clinical Trials Information System (CTIS) [56, 57, 78, 79]) before study start, defined for GPP purposes as participant enrollment. When possible, the registry record should be updated with citations to primary and secondary publications (80). Automatic linking of registry information with indexed publications is enabled by including study identifiers in publications. As consistent with local regulations and requirements of granting or funding bodies, study data should be posted, often within 12 months of study completion; lay summaries are also recommended (72, 81). Some journals also require registration of other studies, such as meta- analyses, in appropriate databases. Preregistration of Clinical Some journals encourage preregistration of protocols as registered reports before data Trial Protocols collection (e.g., the Center for Open Science ). If the report passes peer review, a manuscript is provisionally accepted for publication pending a second round of peer review (82). A significant change to study conduct could invalidate this initial peer review. DOI = digital object identifier; GPP = Good Publication Practice; ICMJE = International Committee of Medical Journal Editors. Section F. Publication Working include ICMJE (3) and documents in the EQUATOR Network (17). The National Library of Medicine also Groups maintains a listing of guidelines, including patient We use the term “publication working group” to reporting guidelines (83). The Consolidated Standards refer to the colleagues who manage the authoring of Reporting Trials (CONSORT) checklist (18), for and submission of abstracts, presentations, and example, should be used for all randomized, controlled publications from the same study or predefined data clinical trial publications. analysis or a closely related studies or datasets. Initiation If a publication SC is in place for the work overseen The publication working group should be formed by the publication working group, the responsibilities by a publication SC, the lead author, or a publication for these two groups should be specified so as not professional. A lead author should be selected, based to overlap. on their expertise and existing contributions to the Responsibilities intellectual work of the research be reported. This The publication working group develops publication author should meet ICMJE authorship criterion 1 at the content following appropriate guidelines, obtains time of this selection (3). required review and approval, holds meetings as Membership needed, manages the peer review process, maintains Membership in the publication working group is auditable documentation, and (as applicable) not obligatory and does not automatically confer communicates with the publication SC and additional authorship. stakeholders, such as study investigators. Eligible authors and other contributors should be A sponsor employee, such as the clinical or medical invited to participate by the lead author or a publication lead, should ensure that appropriate study data are professional on their behalf. All potentially eligible shared with publication working group members. authors according to ICMJE criterion 1 should be All publication stakeholders should follow reporting invited to serve within the publication working group standards and guidelines that help ensure the credibility (3). When appropriate, patients and patient advocates and reproducibility of study data, as appropriate for should be included in the publication working group study and publication types. Some suggested standards before writing begins (84). DeTora LM, et al. Ann Intern Med. 2022 11 Good Publication Practice 2022: Supplement For large study teams, a publication SC or author ICMJE author criteria should be used as a default if adjudication working group might consider which journal selection is not finalized. contributors to study design and conduct will have the Additional Meetings greatest ability to analyze and interpret data and take public responsibility for the work and should therefore Working group meetings may be held to discuss be invited to serve as byline authors. We recommend publication contents and interpretation of data. the use of Contributor Roles Taxonomy (CRediT) (85–87) Consensus meetings may be needed and should or a similar guideline to collect necessary information be held to reconcile any conflicting opinions and for making such decisions. A qualified author should comments. Meetings may be required to review or be able to serve as a presenter for planned regional obtain additional data analyses. conferences (if applicable). Inclusivity should be Communication considered when selecting byline authors. Meeting minutes and tracking documents should be For publications of secondary and other analyses of maintained in an auditable format. The lead author or clinical trial data, we recommend that one or more publication professional should provide status updates qualified authors of the primary publication participate to the SC. as a contributor or co-author. It is not necessary for all If patients are included in the publication working authors from the primary study publication to appear on group, they should be periodically invited to share the bylines of articles presenting secondary endpoints their experiences and make suggestions for the better or meta-analyses of the study data. Publications that functioning of the team (89). solely analyze or review previously published and/or publicly accessible data are not required to include an Ending author from the original publication. Once all applicable deliverables are published, the Patients and patient advocates should be regarded as publication working group should be disbanded. experts who may give important input into publications However, the corresponding author may reconvene (88). Patients may serve as consultants, authors, or the publication working group if needed to issue any contributors to publications, depending on journal needed corrections to an existing publication. and conference requirements. Patients may highlight relevant information for people living with a particular disease and may help explain complex information in Section G. Authorship and plain language. Patients also may review publications, Contributorship Determination PLSs, and/or enhanced content for usability. Principles Colleagues whose job roles are primarily to support sales, marketing, or other strategic commercial Awareness of Authorship Criteria activities may not influence content development, ICMJE authorship criteria (3) should be the default review, or approval for biomedical publications. specified in authorship agreements, research For the purposes of GPP, colleagues performing agreements, and contracts, with the caveat that scientific or medical study functions, including HEOR, individual journal or conference guidelines may differ medical affairs, and RWE studies, are considered to be and, in that case, must be followed. The explanatory researchers regardless of the reporting structure for text provided by the ICMJE should be used and not their job function within a company. only the list of criteria. Paid employment in any role that contributes to Meetings and Communication study conduct, analysis, or publication development Kick-Off Meeting (including professional medical writing) is not a The publication working group should have a kick-off disqualification from authorship. meeting before study data become available to discuss Practices such as ghostwriting, ghost authorship (failing the team’s scope in terms of publication activities and to list qualified authors as such), guest authorship to assign roles and responsibilities. The sponsor’s (giving authorship credit to those who do not meet process for manuscript development, review, approval, appropriate criteria), and relinquished authorship and submission should be provided. (forcing otherwise qualified authors to opt off bylines The process for dispute arbitration, escalation, and to accommodate academic authors (35, 36) are mediation should be reviewed at the kick-off meeting. inconsistent with GPP. If team members are not already familiar with existing Open Researcher and Contributor ID (ORCID) should publications policies, these GPP guidelines and/ be used to ensure transparency of author identities or applicable author standards should be reviewed. (90–92). DeTora LM, et al. Ann Intern Med. 2022 12 Good Publication Practice 2022: Supplement Consensus Building acknowledged for their contributions to the research, Authors and contributors are responsible for achieving such as study investigators, persons who provided consensus on byline authorship, author sequence, important technical expertise, or the participants corresponding authorship, posthumous publication, (often as a group), should also be included. People and continued eligibility for authorship should who reviewed the publication and provided helpful someone leave the team. A publication SC may form an advice may also be acknowledged. Written permission authorship adjudication working group to help resolve should be collected before including the names of disputes, should such arise. contributors in a publication. Even Application of Authorship Criteria When journals or conferences do not allow inclusion of acknowledgments within the publication or Authorship criteria should be applied consistently to presentation, we recommend including this information all contributors, including patients and professional with the submission (e.g., in a cover letter) or in a medical writers, regardless of their affiliation, supplementary file. This information also should be professional role, or level of educational attainment. documented in the project file in case of future queries. Authorship is not to be automatically conferred (or denied) based on a present job role or function. Author Agreements Patients who qualify as authors should be listed as such Author agreements should describe the ethical and and their contributions should be acknowledged as for other obligations of sponsors and authors (Supplement all other authors and contributors. Patient authors may Table 4). Author roles and responsibilities should be be listed as such on the author byline (3). confirmed in writing prior to the start of publication All qualified authors (and no unqualified contributors) development. Email or agreement in a publication should be included on the author byline or as part management system may be used for such of an “author group.” Joint authorship is increasingly confirmations. common and acceptable if the other authors agree Author agreements may be put in place for individual (93, 94). The need to present data in different regions publications, or all the publications managed by a and languages should be anticipated when choosing publication working group. Author agreements should byline authors. ICMJE recommends including authors respect the various institutional policies of the authors, from all regions in which research was performed (3). investigators, and other contributors. Guidelines such as CRediT (85) or published authorship Author agreements may describe how to handle checklists and grids may be useful in helping teams author sequence, group or joint authorship, and other build consensus around questions of authorship, situations listed in Supplement Table 5. including ordering in bylines (87, 95–99). Author agreements may state that authors will not It is not acceptable to manipulate job responsibilities receive payment in exchange for listing their name on or journal selection to limit authorship numbers or a publication byline; however, this statement does not to reduce the appearance of company involvement automatically disqualify from authorship professional in research. Company employees who qualify for medical writers or any other person earning a salary authorship should not relinquish it. from professional activities that may confer authorship. Contributorship Models Nor should such a statement be interpreted as a prohibition for compensating patients or other We encourage using a contributorship model to participants in publication activities, such as patient describe each person’s role in the development of advocates or SC members, for their time. a publication or presentation (85). Clear, concise descriptions of the roles and affiliation of each author and Author agreements may also specify other information any listed nonauthor contributors should be included and obligations, such as a grant funder’s requirement within each publication or presentation. Names of to publish results in an open-access journal. persons who did not contribute to the manuscript or We recommend that authors not enter into agreements presentation development but who deserve to be that do not uphold the principles of GPP. DeTora LM, et al. Ann Intern Med. 2022 13 Good Publication Practice 2022: Supplement Supplement Table 4.Suggested Author Agreement Contents Item Explanation Author Responsibilities Follow GPP and Commitments Meet designated author criteria (use ICMJE as default ) Take responsibility for the content, accuracy, and completeness of the publication and approval of final versions Inform, as applicable, the sponsors and other authors of relevant publication policies from the authors’ institutions Adhere to journal or conference guidelines, protect confidential information, respect embargoes Provide relevant financial and other disclosures, as requested by journals or conferences Confirm affiliation(s), ORCID, and any other information needed for submission Sponsor Responsibilities Provide authors with access to all study information necessary to prepare the publication and Commitments or presentation (e.g., the protocol, statistical analysis plan, and study report, relevant anonymized data) before writing begins Provide clear information, such as trial identifiers, to differentiate datasets Provide reasonable additional data and analyses in support of the publication on request Inform authors of the publication process to be followed and provide a copy of their publication policy on request Advise the authors of the sponsors’ financial reporting requirements (if any) to comply with transparency laws and regulations, including any Transfer of Value monetary amounts reported to database systems such as the U.S. Centers for Medicare & Medicaid Services Open Payments Confirm the authors’ freedom to publish the study results without undue interference Disclose the sponsor role in review of the publication or presentation (e.g., for medical accuracy, IP protection, or other legal or regulatory review), and provide a reasonable timeline for review to be completed (30 days is the recommended maximum) Describe what, if any, editorial, writing, and other support may be available and ensure that authors have an opportunity to agree to (or not) writing and other support Collaboration Authors, contributors, and sponsor(s) will work together to adhere to current good Commitments publication practices and appropriate authorship criteria Base consensus on honest scientific debate to resolve differences in interpretation of findings, data presentation, journal or conference selection, authorship, and acknowledgments A method for dispute resolution may be included If applicable, the group will work with patient authors to make adjustments in technical requirements and timelines so as not to limit their ability to participate (84) Professional Writing Before a professional medical writer begins to work on a manuscript, authors must have Support agreed to work with the writer, disclose this assistance in an acknowledgment, and confer byline authorship should such criteria be met by the writer Authors are not required to accept professional writing support Policies Acknowledge that the institutional policies of authors, investigators, other contributors, and sponsors should be followed DeTora LM, et al. Ann Intern Med. 2022 14 Good Publication Practice 2022: Supplement Supplement Table 4. Suggested Author Agreement Contents (Cont’d) Disclosure Guidance Authors are responsible for disclosing relationships that could be perceived to bias their work or influence professional judgment, including both financial and nonfinancial relationships with commercial or noncommercial entities (92) Receipt of payment or services from a third party (government, commercial, private foundation, etc.) for any aspect of the submitted work (including, but not limited to, grants, data monitoring board, study design, manuscript preparation services, meeting travel, statistical analysis, or writing assistance) must be disclosed (100). Disclosures of writing and technical support may be different for encore presentations. Although guidance about relevant disclosures may be offered by the journal or conference, policies at authors’ home institutions should also be followed. For consistency, it may be preferable for all authors to follow the most stringent disclosure or conflict of interest criteria. The Convey system (101) provides helpful advice If applicable, information about a granting body, the grant identifier, and any disclosure statement required by the funder should be listed Additional elements to consider: — For relevant activities outside the submitted work, include the names of, and relationship with, all pharmaceutical, biologics, medical device, and diagnostics manufacturers in which an author (or close family member) is employed, is a contractor, provides services, or has otherwise collaborated in commercial or scientific pursuits—even in the absence of direct payment — Royalties, stock holdings, and issued or pending patents of an author or family member may also be relevant — For transparency, disclosures of the above two types that do not seem directly relevant may still be made — If no time frame for disclosure is specified by the journal or conference, we recommend following the ICMJE disclosure form (100) and using a 36-month disclosure window Confidentiality Authors should have an agreement with the sponsor regarding confidentiality and respecting data embargoes GPP = Good Publication Practice; ICMJE = International Committee of Medical Journal Editors; IP = intellectual property; ORCID = Open Researcher and Contributor ID. Additional Considerations Consistency Group Authorship, Study Groups, and Author lists should remain consistent for a specific dataset, and encore presentations should list the same Investigator Listings authors as the original presentation. Direct translations An “author group” may be listed, consistent with of presentations by nonauthor presenters for local journal and conference guidelines, when the number language conferences may be needed, as permitted of qualified authors is prohibitive to list in an author by the conference (7). Manuscripts should reflect the byline. Generally, such circumstances are limited, (e.g., authorship of earlier presentations; if a colleague served multiregional consensus statements). as an author for a conference presentation and opts out It is often permissible to list all contributing investigators of the byline for a subsequent manuscript, this earlier and other members of study teams as part of a “study authorship should be noted in an acknowledgment or group” or “investigator group”. These designations cited. may not require that all group members qualify as authors, and such designations may be indexed to aid Ongoing Assessment in promotion and tenure cases (3). The intention to list Authorship should be assessed throughout publication members of the study group and/or investigator group development (Supplement Table 5). Authors and in publications (and any responsibilities to be listed) contributors should agree on what constitutes should be communicated at the start of research. “substantial” contributions. DeTora LM, et al. Ann Intern Med. 2022 15 Good Publication Practice 2022: Supplement Supplement Table 5. C onsiderations for Authorship Assessment Authorship Issue Guidance Number of Authors No policies should arbitrarily limit author numbers (3) However, it is judicious to assign study and publication responsibilities so that the number of contributors in a functional area is reasonable It is not permissible to divide professional responsibilities intentionally to disqualify or reduce the number of sponsor authors Author Sequence The significance of author sequence may vary by scientific specialty and therapeutic area. Those who made the most contributions should be credited accordingly The authors should agree to byline sequence, and the lead author may settle disputes. However, deferring to a neutral criterion such as alphabetical or reverse alphabetical order is recommended in cases of equal contributions (96) Addition of Authors After If the work to be published substantially changes in response to peer review (e.g., Submission adding or removing analyses), the addition of an author might be considered as consistent with journal guidelines. All authors must agree to such a change Death or Incapacity of an Author Should a qualified author die or become incapacitated during publication development, they may be retained on the author byline if the journal or conference permits, with the agreement of the remaining authors. Consultation should be made to determine whether copyright transfer is necessary and, if so, who will execute it Change of Afﬁliation Change of affiliation is not a disqualification for authorship but may impede the ability of an otherwise qualified author to fulfill responsibilities. Reasonable efforts should be made to include all people who made intellectual contributions to study design, analysis, and/or data interpretation as authors. Listed affiliations should reflect author positions during the work to be published and be specified in the author agreement (if applicable). Footnotes may be used to designate current affiliations. ORCID numbers are recommended. GPP = Good Publication Practice; ORCID = Open Researcher and Contributor ID. Process by the journal or conference. Authors should approve Identify Applicable Authorship Criteria the publication version to be submitted and state a commitment to take public responsibility for the work, A publication professional or lead author should which may be done via email. review the author requirements for the target journal or conference during the publication working group Each person named in acknowledgments should review kick-off meeting (See Section F). An email may be the wording of the acknowledgement describing substituted for follow-on publications for publication their contribution and provide written permission working groups that are responsible for multiple to be included. Nonauthor contributors should not deliverables. be expected to approve the final manuscript or Reminders presentation, but a courtesy copy should be provided to them. During authoring, review, and approval, it may be helpful to remind potential authors of applicable Reassessment of Author Criteria During Peer authorship criteria in the email or memo that Review accompanies review requests. Substantive revisions during the peer review process Presubmission Checks may result in changes, generally additions, to the Authors should complete a contribution checklist, author list and acknowledgments. Any such changes such as CRediT (85) or ICMJE (3), even if not required must be made following applicable journal guidelines. DeTora LM, et al. Ann Intern Med. 2022 16 Good Publication Practice 2022: Supplement Section H. Publication Process Supplement Table 6.Relevant Criteria for Journal and The process for developing an individual publication is Conference Selection illustrated in Supplement Figure 2. Criterion Notes The below publication process applies to publication Editorial Scope General or specialty journals or working groups, as described in Section F. As noted, and Audience conferences early activities may be completed by a publication SC Regional journals or conferences prior to the formation of the publication working group Credibility Reputation of the journal, publisher, or (See Sections D and E). professional society, indexing in major databases (102, 103) Journal and Conference Selection Discoverability Indexing in PubMed, MEDLINE, or Credible journals and conferences should be chosen another reputable indexing service (e.g., to support scientific communication to appropriate SCOPUS, Embase) for the subject matter groups (102, 103). If the credibility of a journal or Technical Types of publications, word count, conference cannot be reasonably ascertained, it Considerations figure/table count, supplementary should be avoided (102–104). Publication professionals material options, language), costs (e.g., may suggest reputable journals and conferences, but processing or publication charges, authors should make the final decision about the target open-access fees), and anticipated journal or conference. speed of peer review process and timing The SC or publication working group may investigate Ability for Policies for licensing and copyrights the requirements for two to three journal or conference Authors to (e.g., Creative Commons CC-BY, or options prior to the kick-off meeting (105). Journals Reuse Contents other license applied) have varied requirements, which should be considered Editorial Authorship, ORCID registration, data when selecting options. Prepublication checklists may Policies sharing, prior publication, preprint be useful in identifying different requirements. policies, Epub ahead of print Presubmission inquiries to editors about a specific Communication Accessibility of contents should be publication or dataset may be necessary, but this With the Public considered: open-access (106) or free- to-access options and timing; enhanced generally should be done only with the agreement of publication content and PLS options; the authors. social media and press release about a Relevant criteria for journal and conference selection publication by the journal/publisher include those mentioned in Supplement Table 6. ORCID = Open Researcher and Contributor ID; PLS = plain language summary. Supplement Figure 2. Overview of the Publication Process Kick-off Before: Data to be shared with authors During: Discuss medical writer support, discuss key data and enhanced content, agree target journal/conference and timelines Follow-up: Confirmation of agreed steps to all authors Final draft Review and approval Publication draft(s) Publication to be cross-checked against Lead author, publication professional or writer Once drafted, all authors should critically journal/conference guidelines manages company review and approval process review the content Disclosure information and written All comments received to be shared with all authors For conflicting comments, consensus should permissions for acknowledgments obtained be reached via discussion with author group All authors must approve final version prior All authors are responsible to the accuracy to submission and quality of the publication Journal/conference submission, Post-publication peer review and proofs Corresponding author should manage any Corresponding author should oversee the submission process communications with the journal around All authors should review peer review comments and evaluate errata, etc, informing all authors as required prior to any revisions Any enhanced content must be in line with the revised manuscript following acceptance DeTora LM, et al. Ann Intern Med. 2022 17 Good Publication Practice 2022: Supplement Data Sharing the lead author or publication professional. In such Sponsors must provide authors and other contributors cases, the medical writer may consider the author with relevant aggregated study data, consistent with agreement to be written confirmation. patient confidentiality, before work on a publication It is advisable to agree to the role of the writer in such begins or as soon as data becomes available during tasks as publication submission and addressing peer publication development (25). review comments. Medical writers should be enabled Authors should have an opportunity to review study to follow GPP in their work and not be requested to data before the kick-off meeting or first draft of a perform any activities that are inconsistent with GPP. publication begins. If a publication professional or Publication Kick Off medical writer is supporting publication development, they should attend any data dissemination and The publication kick off may be initiated by a publication discussion meetings to ensure that author views are professional or professional medical writer. Depending captured in initial publication drafts. on existing working relationships, work may begin via a live meeting, teleconference, videoconference, or Data provided to authors should minimally include email. Existing working group members should identify prespeciﬁed primary and secondary outcomes and any other data that should be included on websites for additional persons qualified as potential authors. clinical trial data posting. Redacted clinical study reports A discussion guide that presents key study data may be or clinical study report synopses may be helpful as may helpful for the kick-off meeting; however, the outline regulatory lay summaries of clinical data. Information and discussion points to appear in the publication necessary to appraise the quality and robustness of the should be based on author guidance. The working ﬁndings (e.g., study protocol, statistical analysis plan, group should agree on the process to be followed, statistical report, and validated data tables, figures, including the number of drafts, particularly if drafts are listings) should be provided if needed. limited by a contract with a communication agency. Authors may request additional analyses, which should The timing and process for publication drafts, be provided if feasible and reasonable for the scope development of enhanced content (if any), of the planned publication. Authors who have signed a supplemental materials, and PLSs should be reviewed, confidentiality agreement should be permitted access as should disclosure policies and requirements. to any requested study data, consistent with protecting A specific plan for document retention, including patient confidentiality. responsibilities of authors and other contributors and the documents to be retained, should be reviewed. Working With Professional Medical Writers Timelines for manuscript drafts, author comments, review, and approval should be realistic. Holidays, Authors must agree to the involvement of a professional illnesses, and professional activities, such as medical writer, if applicable (26). Ideally, the writer will presentations at conferences, should be considered. attend the kick-off meeting. Patient authors and patient advocates, in particular, Consistent with general good practice, before may need time accommodations and other authors beginning work, a professional medical writer should should respect this need. confirm the following in writing. The authors control and direct publication contents. Publication Draft The writer must receive direction from the authors A subset of authors should compose a publication before they undertake any writing, including an outline or draft for critical author review, following outline. appropriate guidelines. A professional medical writer All authors have agreed to the writer’s involvement. may assist with the first full draft. For clinical trials, CONSORT or other applicable guidelines should All authors have a documented agreement with the be followed (17). All clinical trial manuscripts should sponsor that identifies their respective rights, roles, and responsibilities. designate whether they present primary, secondary, or other sorts of analyses. Any prior publications and The authors will disclose, at a minimum, the writer’s presentations from the dataset should be cited. name, professional qualifications, affiliation, funding source, and any other information required by the

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