Publication of Clinical Research (L11; E3)
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Questions and Answers

What is the primary ethical responsibility of the investigator in clinical research?

  • To ensure the design and execution of the study protects the patient's rights. (correct)
  • To follow the sponsor's protocol exactly without changes.
  • To minimize the duration of the study to reduce costs.
  • To ensure the study includes as many participants as possible.

    • Why is it important for investigators not to simply accept sponsor-drafted protocols?

  • Sponsors are typically experts in research designs.
  • Investigators may produce biased results if they do.
  • Protocols can be too complex for investigators to understand.
  • It can compromise the quality and objectivity of the research. (correct)

    • Which of the following is a critical aspect of defining end points in a clinical trial?

  • End points should be flexible to accommodate changes during the trial.
  • Stopping points should be determined after preliminary results.
  • End points must provide evidence of the treatment’s efficacy. (correct)
  • End points should only reflect patient satisfaction outcomes.

    • What potential issue arises from having too favorable inclusion and exclusion criteria in a study?

    <p>It may lead to results that do not represent the general population.</p> Signup and view all the answers

    How should randomization be structured in clinical trials?

    <p>The mechanism of randomization must be well-defined and double blinded.</p> Signup and view all the answers

    What is a potential consequence of failing to publish negative trial results?

    <p>Continuation of harmful patient treatment.</p> Signup and view all the answers

    What is one requirement that should be established before a clinical study begins?

    <p>A publication committee among the principal investigators.</p> Signup and view all the answers

    How should companies handle reports of serious adverse events in clinical trials?

    <p>They should circulate reports to all investigators promptly.</p> Signup and view all the answers

    What is a common issue related to the publication of negative trial results?

    <p>They are frequently ignored or not submitted for publication.</p> Signup and view all the answers

    What timeframe should a company typically allow for review before publishing study results?

    <p>90 days.</p> Signup and view all the answers

    What is one of the recommendations made by the AMA regarding investigators in industry-sponsored research?

    <p>Investigators should not hold stock or stock options in the sponsoring company.</p> Signup and view all the answers

    What is the purpose of nondisclosure agreements in the context of industry-supported research?

    <p>To protect the company's proprietary information from being disclosed.</p> Signup and view all the answers

    Which clause is particularly important to review when entering a research contract to ensure patient safety?

    <p>The clause regarding publication rights.</p> Signup and view all the answers

    What is one of the responsibilities of the Institutional Review Board (IRB) in clinical research?

    <p>To approve the study design as scientifically valid</p> Signup and view all the answers

    What issue was highlighted by the Olivieri case regarding contract agreements in clinical research?

    <p>Contracts can impose severe restrictions on the disclosure of research information.</p> Signup and view all the answers

    Why is frequent reporting from the data-monitoring committee important during a clinical trial?

    <p>To detect unexpected complications and maintain patient safety</p> Signup and view all the answers

    Which of the following is a potential consequence for investigators from nondisclosure agreements?

    <p>They might lose the ability to publish their findings.</p> Signup and view all the answers

    What potential issue arises when a company controls the data in clinical research?

    <p>Investigators might lack access to raw data for comprehensive analysis</p> Signup and view all the answers

    What role does the data-monitoring committee play in clinical trials?

    <p>To protect patient interests and ensure ethical conduct</p> Signup and view all the answers

    What is a common problem associated with the summarized analysis provided by the company to investigators?

    <p>Investigators often cannot access raw data to respond adequately to reviewers</p> Signup and view all the answers

    Study Notes

    Publication of Clinical Research

    • 58% of published randomized controlled trials (RCTs) are non-industry sponsored, while 42% are industry sponsored. (Gross et al., 2002)
    • Complex interactions exist between industry, investigators, patients, regulatory bodies, and other stakeholders in clinical research. (Rutherford, 2000)

    Types of Conflicts

    • Non-financial conflicts include:
      • Desire to prove prior hypotheses were correct
      • Self-promotion/peer recognition
      • Political agendas
      • Religious beliefs
    • Financial conflicts include:
      • Study support
      • Investigator support to conduct a study
      • Royalties/patents
      • Expert Witness
      • "Insider" information

    Prevalence of Financial Conflicts

    • 22% of community internists participated in industry trials in 2003.
    • 28% of faculty received industry research funds in 1996.
    • 124 academic institutions held equity in businesses engaged in research at the same institution.
    • 36% of IRB members had financial conflicts in 2006. (Ashar et al., 2004; Blumenthal et al., 1996; Campbell et al., 2006)

    Financial Conflict of Interest

    • Defined as situations where financial considerations compromise or appear to compromise an investigator's judgment in conducting or reporting research. (1990 AAMC Guidelines)
    • Authors' published opinions strongly correlate with their financial arrangements. (Gross, 200X)

    Study Design Bias

    • Example: Fluconazole vs. amphotericin B, where 92% of trial patients were in trials sponsored by the manufacturer of fluconazole. (Johansen et al., 20XX)
    • Oral amphotericin was a poorly absorbed comparison agent rarely used for systemic infections.
    • Fluconazole shows a wonder-drug effect compared to the poorly performing control.

    Systematic Review: Industry Sponsorship vs. Study Outcome

    • Industry-supported studies often had a hazard ratio greater than one, suggesting a positive impact. (Bekelman et al., 2003)

    Financial Conflicts in Research

    • Financial conflicts in research are pervasive, powerful, clinically hazardous, and threaten scientific integrity.

    Potential Problems with Industry-Supported Clinical Research

    • Financial conflicts of interest
    • Nondisclosure agreements
    • Research contracts
    • Development of research protocols
    • Comparative groups (inclusion/exclusion criteria)
    • Blinding and randomization
    • End points
    • Cost considerations
    • Institutional review board (IRB) approval
    • Data analysis
    • Data collection, analysis, and control of data (data monitoring committee)
    • Interim data release
    • Presentation and publication of data
    • Adverse events
    • Delays in publication
    • Multiple publications
    • Publication committees
    • Contract complexity and potential for investigator rights/integrity issues

    Case Studies

    • The Olivieri case highlights issues with financial conflicts and contracts. (Rutherford, 2000)
    • The Rhone-Poulenc-Rorer case demonstrates a more positive relationship between industry and investigator. (Rutherford, 2000)

    Journals

    • Journals emphasize author independence, objective data analysis, and publication bias.

    Trial Registration

    • Trial registration is required for trials and includes details like hypothesis, interventions, endpoints, eligibility criteria, and funding sources. (ICMJE, 2005)

    JAMA Policy Regarding Data Analysis

    • Industry-sponsored studies must have independent statisticians who are identified and provided with the entire raw data set, study protocol, and analytic plan.

    Disclosure to Participants

    • Consent forms should disclose conflicts of interest, with committee oversight.
    • A 2004 survey of IRBs found that disclosure was suggested by 48% of IRBs in surveys but oversaw financial conflicts by only 4%.

    Types of Scientific Misconduct from Self-Reports

    • Overinterpretation
    • Selective reporting
    • Subgroup analyses
    • Negative outcomes
    • Inappropriate subgroup analysis
    • Reporting issues
    • Analysis by sponsor

    Publication Standards

    • Editorial oversight and independent investigations are key for controlling misconduct.
    • Consolidated Standards of Reporting Trials (CONSORT) guidelines improve clinical trial reporting.

    Methods to Limit Ethical Misconduct in Clinical Trials

    • Pre-trial: Institutional/funding agencies take responsibility for training, contracting, monitoring, and reporting.
    • Individual/Research Teams: Use of publication standards (e.g., CONSORT).
    • Peer and Editorial Review
    • Open Access Publishing

    CONSORT E-CHECKLIST

    • Detailed checklist for describing information needed in publication of clinical trials (see specific pages 30, and 31 for full list).

    Meta-analysis Principles

    • All trials must be included, regardless of publication status.

    • Identification of all relevant trials is crucial

    • Randomly select trials, do not arbitrarily lump trials.

    • Reanalysis of raw data is preferred for uniform endpoints

    • Appropriate measures of trial quality should be used.

    • Sensitivity analyses are needed to evaluate robustness of conclusions.

    • Be careful lumping fundamentally different interventions into analysis

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    Publication of Clinical Research PDF

    Description

    This quiz explores the essential ethical responsibilities of investigators in clinical research. It covers topics such as the importance of critically evaluating sponsor-drafted protocols and the implications of inclusion/exclusion criteria in studies. Participants will also learn about issues related to the publication of clinical trial results.

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