Sharing Clinical Trial Data Maximizing Benefits, Minimizing Risk (2015) / Chapter Skim
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1 Introduction
1 Introduction
Pages 17-30
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Organized and motivated groups of patients and healthy individuals can and are moving beyond the traditional research and health systems to publicly generate 1 Theclinical trials enterprise encompasses the full spectrum of clinical trials and their applications. It includes the processes, institutions, and individuals that participate in research, as well as those who eventually apply clinical trial findings in a care setting.
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Furthermore, sharing clinical trial data might accelerate the drug discovery and development process, reducing redundancies and facilitating the identification and validation of new drug targets or surrogate endpoints. In short, there are today many missed opportunities to gain scientific knowledge from clinical trial data that could strengthen the evidence base for the treatment decisions of physicians and patients.
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, and The Wellcome Trust; biomedical journals; and participant groups. The Food and Drug Administration Modernization Act of 1997 mandated registration on ClinicalTrials.gov of federally or privately funded clinical trials conducted under Investigational New Drug applications (INDs)
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Further, data sharing involves costs, burdens, risks, lack of incentives, and even disincentives that need to be addressed from the perspectives of multiple stakeholders. Progress Since the 2012 IOM Workshop Since the 2012 workshop was held, momentum has continued to build for sharing clinical trial data.
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. • The British Medical Journal issued a policy requiring data sharing for clinical trials it publishes (BMJ, 2013)
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that was released in January 2014 for public comment, summarizing the committee's tentative findings regarding guiding principles and describing a selected set of data sharing activities; and • a final report containing conclusions and recommendations related to the committee's full charge. To respond to this charge, the IOM convened a 13-member committee comprising experts in key scientific and research-related domains, including academia, industry, funding bodies, regulatory activities, scientific publications, clinicians, and patients.
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For the purposes of this study, data generator will include industry sponsors, data repositories, and researchers conducting clinical trials. Specifically, the committee will: • rticulate guiding principles that underpin the responsible sharing of clinical A trial data. • escribe a selected set of data and data sharing activities, including but not D limited to: − Types of data (e.g., summary, participant)
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The committee further found it useful to consider inter ventional clinical trials in two broad categories -- those studies intended and those not intended to support a regulatory application. Data sharing is the practice of making data*
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The Framework articulated the committee's preliminary observations on guiding principles for the responsible sharing of clinical trial data, a nomenclature for data sharing, and a description of a selected set of data sharing activities. The Framework did not contain conclusions or recommendations but rather served to elicit feedback from a variety of stakeholders to inform the second phase of this study and the conclusions and recommendations contained in this final report.
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It is the committee's hope that the rationale for data sharing, the guiding principles, and the recommendations articulated in this report will apply to a broad range of current and future trials. Although much current discussion has focused on trials conducted by large pharmaceutical companies and publicly funded trials conducted in academic medical centers, the committee also considered, consistent with its charge, • clinical trials involving educational interventions, quality improve ment, behavioral interventions, and health care delivery modifica tions as well as drug trials; • trials carried out in resource-poor settings, where unfunded man dates or expectations for data would be particularly burdensome; and • clinical trials sponsored by small nonprofits and small companies without a revenue stream and investigator-initiated trials with no external funding, cases in which resources for data sharing will be very limited.
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In its analyses and recommendations, the committee focused on present-day challenges and constraints while also attempting to account for such potential changes in the landscape in which clinical trials are conducted and in the attitudes of clinical trial investigators, sponsors, and the public toward data sharing, which cannot be fully anticipated. Organization of the Report Following this introduction, Chapter 2 presents the major potential benefits and risks of sharing clinical trial data and the guiding principles set forth in the Framework document.
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2014. BIO principles on clinical trial data shar ing.
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2013. EFPIA and PhRMA release joint principles for responsible clinical trial data sharing to benefit patients.
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Paper presented at IOM Committee on Strategies for Responsible Sharing of Clinical Trial Data: Meeting One, October 22-23, Washington, DC. Terry, S
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