Podcast
Questions and Answers
What is a primary reason for forming a Publication Steering Committee?
What is a primary reason for forming a Publication Steering Committee?
When does the Publication Steering Committee first meet?
When does the Publication Steering Committee first meet?
What should happen to the roles regarding publication and presentations?
What should happen to the roles regarding publication and presentations?
What is the purpose of ensuring appropriate and transparent authorship decisions?
What is the purpose of ensuring appropriate and transparent authorship decisions?
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How often does the committee meet after the initial planning session?
How often does the committee meet after the initial planning session?
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What specific information is provided to study investigators regarding the committee?
What specific information is provided to study investigators regarding the committee?
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What is the outcome when the writing and review process is complete?
What is the outcome when the writing and review process is complete?
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What is the necessity of establishing a charter or guidance document?
What is the necessity of establishing a charter or guidance document?
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Before the Publication Steering Committee is formed, which stakeholders are typically involved?
Before the Publication Steering Committee is formed, which stakeholders are typically involved?
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What key factor is to be monitored during data availability?
What key factor is to be monitored during data availability?
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Study Notes
Publication Plans Principles
- Auditable publication plans adhere to Good Publication Practice (GPP) and sponsor policies.
- All relevant clinical trial data, including regional studies, must be included in the publication plan.
- Priority is given to primary publications detailing prespecified primary endpoints over secondary publications and reviews.
- Background information, including new methods and techniques, should be published prior to clinical data.
Budgeting and Scientific Needs
- All components of publications, such as plain language summaries and enhanced content, must be factored into planning and budgeting.
- Identification of scientific and clinical needs is essential for secondary analyses, pooled data analyses, or systematic reviews.
Journal Selection and Access
- Selection of journals and conferences must be appropriate; timelines should align with data availability.
- Prioritize open-access and free-to-access publication options.
Publication Integrity and Author Responsibilities
- Encore publications and translations should meet scientific needs or reach audiences with limited access to the original work.
- Authors must be informed of their roles and responsibilities promptly, with relevant working groups established for publication development.
- Authors should have access to relevant study data, ensuring consistency across various publication formats.
Embargo and Communication Policies
- Respect embargoes set by journals or conferences; improper communication about trials must be avoided.
- Social media and press releases are to be handled by designated individuals and groups to uphold embargoes.
Feasibility and Timing
- Publication planning must consider the timing capabilities of authors and contributors, especially when multiple publications are in progress.
- Ample time should be allocated for proofreading, data verification, and quality assurance.
Preprint Considerations
- Preprints can refine research questions and analyses; they may also be indexed and assigned DOIs.
- Journal policies fluctuate regarding preprints; some recognize them as prior publications, while others do not allow citations from them.
Publication Steering Committee Lifecycle
- Formation of a publication steering committee is initiated by sponsors or publication professionals before data availability, involving both internal and external stakeholders.
- Responsibilities are defined through a charter or guidance document before meetings commence for planning presentations and publications.
- Regular updates are conducted as data becomes available and publication roles are agreed upon to ensure transparency in authorship decisions.
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Description
This quiz covers the principles for developing auditable publication plans in compliance with Good Publication Practice (GPP) and sponsor policies. It emphasizes the importance of reflecting all clinical trial data and pertinent research in publication efforts. Test your understanding of these essential publication guidelines.
