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Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
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1

Introduction

The clinical trials enterprise,1 tasked with testing the safety and efficacy of health interventions and informing medical decisions, is poised to undergo important changes in response to significant and sustained challenges, including the lengthy time frame, high cost, and often limited relevance of the research it produces (NRC and IOM, 2011). A key driver of the changes on the horizon for clinical trials is the increasingly consumer- and patient-driven nature of research and health care (NRC and IOM, 2011). The traditional system of investigators, sponsors, and journal editors as gatekeepers of clinical trials and their results is being tested as calls for “open science” and the democratization of clinical research intensify. Although a large-scale transition is still under way and significant challenges remain, many observers note that early adopters of the principles and practices of open science will be rewarded (Boulton et al., 2011; Walport and Brest, 2011).

The movement toward greater transparency is being further accelerated by trial participants who have emerged from behind the veil of being termed and treated only as “research subjects” to assume the roles of full partners, leaders, and funders of research. Organized and motivated groups of patients and healthy individuals can and are moving beyond the traditional research and health systems to publicly generate

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1 The clinical 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.

Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
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data about themselves and/or the treatments they choose, compare and analyze these data, and share the results (Kaye et al., 2012; Terry and Terry, 2011; Wicks et al., 2014). These efforts suggest a larger cultural shift already under way, one in which the results of research are deemed a public good that can benefit society only when shared in a timely and responsible manner (Loder, 2013; Mello et al., 2013; Ross et al., 2012). Exploring the implementation of this broad societal desire to extract maximal benefit from the data generated by volunteers in a clinical trial reveals a number of benefits and risks to the sharing of clinical trial data. There is significant potential to share these data successfully in a responsible manner that does not entail complete, unfettered access to individual participant data (ClinicalStudyDataRequest.com, 2014; YODA Project, 2014), but determining the appropriate sharing strategy for various types of clinical trial data will require identifying, evaluating, and addressing the benefits and risks involved.

Clinical trials are crucial to determining the safety and efficacy of health interventions. Vast amounts of data are generated over the course of a clinical trial; however, a large portion of these data is never published in peer-reviewed journals (Doshi et al., 2013b; Zarin, 2013). Today, moreover, researchers other than the trialists have limited access to clinical trial data that could be used to reproduce published results, carry out secondary analyses, or combine data from different trials in systematic reviews (Rathi et al., 2012). Public well-being would be enhanced by the additional knowledge that could be gained from these analyses. 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. In economic terms, these missed opportunities result in a suboptimal return on the altruism and contributions of clinical trial participants, the efforts of clinical trialists and research staff, and the financial resources invested by study funders and sponsors (Doshi et al., 2013a). At the same time, however, the sharing of clinical trial data presents risks to various important stakeholders and raises complex challenges regarding the consent and privacy of participants, protection of the legitimate interests of stakeholders, and the development of a sustainable and equitable business model for sharing (IOM, 2013b).

Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
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STUDY CONTEXT

Historical Highlights

Before 2012, the evolution of enhanced transparency in clinical research involved a number of research stakeholders, including international regulatory and funding organizations such as the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), the U.S. National Institutes of Health (NIH), 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) to test the effectiveness of experimental drugs for patients with serious or life-threatening diseases or conditions (Zarin, 2007). The International Committee of Medical Journal Editors further supported trial registration by requiring it as a condition of consideration for publication in 2004 (De Angelis et al., 2004). In 2003, NIH issued its Final Statement on Sharing Research Data, which states that “all investigator-initiated applications with direct costs greater than $500,000 in any single year will be expected to address data sharing in their application” (NIH, 2003). In 2007, the Food and Drug Administration Amendments Act (FDAAA) required reporting of summary results from certain trials (e.g., non-phase 1) of FDA-approved drugs, biologics, and devices to ClinicalTrials.gov, whether the results have been published or not (Zarin, 2011).2 Also in 2007, the Annals of Internal Medicine launched a Reproducible Research initiative, requiring that all original articles include a statement indicating the authors’ willingness to share with the public the study protocol (original and amendments), the statistical code used to generate results, and the data set from which the results were derived (Laine et al., 2007). And in 2009 the British Medical Journal required that authors include data sharing statements at the end of each published article, indicating what data are available, to whom, and how (FDA, 2010; Groves, 2009; Roehr, 2009).

In November 2010, the EMA created an “access to documents” policy and agreed to release clinical study reports (CSRs) to external persons who submit a freedom of information request (EMA, 2014). In 2011, an international group of funders (Inserm, The Wellcome Trust, the UK Medical Research Council, NIH, The World Bank, and others) issued a statement endorsing “making research data sets available to investigators beyond the original research team in a timely and responsible manner, subject to appropriate safeguards” (The Wellcome Trust, 2011). Also in

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2 42 U.S.C. § 282(j)(3)(C).

Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×

2011, the health data sharing platform PatientsLikeMe released the results of a patient-initiated observational study of amyotrophic lateral sclerosis (ALS) patients experimenting with lithium carbonate treatment—the first time a social network of patients convened to evaluate a treatment in real time (PatientsLikeMe, 2011; Wicks et al., 2011).

2012 Institute of Medicine (IOM) Workshop on Sharing Clinical Research Data

In October 2012, the IOM convened a broad range of experts and stakeholders to discuss the sharing of clinical research data. As highlighted by participants at the workshop, data sharing can have important benefits for industry, nonprofit funders of research, academic investigators, patient advocacy groups, and ultimately patients and the public. These benefits include, for example, accelerating medical innovation by reducing redundancies, facilitating the identification and validation of new drug targets, identifying new indications for use, and improving understanding of the safety and efficacy of therapies (IOM, 2013b). Workshop participants suggested that the conversation around sharing clinical research data has evolved from whether the data should be shared to how best to facilitate sharing, and cited examples of data sharing activities that had been established or proposed at the time (EMA, 2014; Krumholz and Ross, 2011; Nisen and Rockhold, 2013; Zarin, 2013). Concerns were raised, however, that the potential benefits of data sharing may not be realized if the sharing is fragmented or conducted largely through uncoordinated initiatives. 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. Major developments include the following:

  • Medtronic and Johnson & Johnson partnered with Yale University Open Data Access (YODA). Medtronic agreed to release all clinical trial data on one product widely used in spine surgery, rBMP2, to academic investigators for reanalysis (YODA Project, 2013). Johnson & Johnson transferred authority to YODA for making decisions on data requests for all Janssen pharmaceutical trials (Johnson & Johnson, 2014).
  • The EMA issued a draft policy, modified it in response to consultation and feedback, and has now issued requirements for sharing
Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×
  • clinical trial data submitted to the agency3 once a marketing decision on the study products has been made (EMA, 2014).

  • The AllTrials campaign was launched, calling for “all past and present clinical trials to be registered and their full methods and summary results reported” (AllTrials, 2013). As of December 2014, more than 81,000 people had signed the AllTrials petition, and 532 organizations had joined AllTrials (AllTrials, 2014).
  • Astellas, Bayer, Boehringer Ingelheim, GlaxoSmithKline, Lilly, Novartis, Roche, Sanofi, Takeda, UCB, and ViiV Healthcare committed to sharing clinical trial data through ClinicalStudyDataRequest. com and allowing an independent review panel to make decisions on data requests (ClinicalStudyDataRequest.com, 2014).
  • The British Medical Journal issued a policy requiring data sharing for clinical trials it publishes (BMJ, 2013).
  • The Pharmaceutical Research and Manufacturers of America (PhRMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Biotechnology Industry Organization (BIO) released principles documents signaling their support for sharing clinical trial data (BIO, 2014; PhRMA, 2013).
  • The National Institute of Allergy and Infectious Diseases (NIAID) made de-identified data from 11 clinical trials available through the Immunology Database and Analysis Portal (ImmPort) (ImmPort, 2013).
  • NIH issued a new policy on sharing of genomic data. The new policy outlines and emphasizes the expectation that investigators will obtain informed consent from study participants for potential future use of the participants’ de-identified data for both research and broad sharing, and commit to sharing data no later than the date of first publication of the study results (NIH, 2014).

Numerous approaches and models for sharing clinical trial data are being implemented with varying levels of access control. At one end of the spectrum, ImmPort in the United States and the FreeBIRD website (FreeBIRD, 2014) in the United Kingdom make available some de-identified data sets from publicly funded clinical trials (NIAID and CRASH trials, respectively) with minimal restrictions; the data sets can be downloaded from the Web upon registration and acceptance of their terms

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3 Clinical trial sponsors seeking regulatory approval from authorities such as the EMA and the FDA must submit detailed CSRs and individual participant data as required, which form the basis of the marketing application for a product. In trials not conducted for regulatory approval of a product, detailed CSRs may or may not be prepared (Doshi et al., 2012; Teden, 2013).

Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×

of use. At the other end of the spectrum, many programs for sharing of clinical trial data from private sponsors (e.g., GlaxoSmithKline, Johnson & Johnson) place various restrictions on data access—for example, requiring review of requests by an independent scientific review board and access through a format that cannot be downloaded. As an increasing number of organizations take the initiative to share their data more actively, the time is right to develop broadly accepted guidance for responsible sharing of clinical trial data that will increase the availability and usefulness of the data while mitigating the risks of data sharing.

CHARGE TO THE COMMITTEE AND STUDY SCOPE

As a follow-up to the 2012 IOM workshop, a group of federal, industry, and U.S. and international foundation sponsors4 asked the IOM to conduct a consensus study that would generate guiding principles and a framework for the responsible sharing of clinical trial data.

As described in the committee’s statement of task (see Box 1-1), over a 17-month study period, the committee was charged with releasing two reports:

  • a discussion framework document (“the Framework”) 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. Individual committee members’ expertise spans academic clinical trial design, performance, and dissemination; pharmaceutical product development; statistics, informatics, and data security; ethics of human subjects research; and law and regulatory requirements (including privacy, security, and intellectual property). Committee members also have insight into the global context of data sharing; the concerns of research participants, patients, and their families; and

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4 AbbVie Inc., Amgen Inc., AstraZeneca Pharmaceuticals, Bayer, Biogen Idec, Bristol-Myers Squibb, Burroughs Wellcome Fund, Doris Duke Charitable Foundation, Eli Lilly and Company, EMD Serono, Genentech, GlaxoSmithKline, Johnson & Johnson, Medical Research Council (UK), Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc., Sanofi-Aventis, Takeda, U.S. Food and Drug Administration, U.S. National Institutes of Health, and The Wellcome Trust.

Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
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BOX 1-1
Statement of Task for This Study

An ad hoc committee of the Institute of Medicine will conduct a study to develop guiding principles and a framework (activities and strategies) for the responsible sharing of clinical trial data. For the purposes of the study, the scope will be limited to interventional clinical trials, and “data sharing” will include the responsible entity (data generator) making the data available via open or restricted access, or exchanged among parties. For the purposes of this study, data generator will include industry sponsors, data repositories, and researchers conducting clinical trials. Specifically, the committee will:

  • Articulate guiding principles that underpin the responsible sharing of clinical trial data.
  • Describe a selected set of data and data sharing activities, including but not limited to:
    • − Types of data (e.g., summary, participant).
    • − Provider(s) and recipient(s) of shared data.
    • − Whether and when data are disclosed publicly, with or without restrictions, or exchanged privately among parties.
  • For each data sharing activity, the committee will:
    • − Identify key benefits of sharing and risks of not sharing for research sponsors and investigators, study participants, regulatory agencies, patient groups, and the public.
    • − Address key challenges and risks of sharing (e.g., resource constraints, implementation, disincentives in the academic research model, changing norms, protection of human subjects and patient privacy, intellectual property/legal issues, preservation of scientific standards and data quality).
    • − Outline strategies and suggest practical approaches to facilitate responsible data sharing.
  • Make recommendations to enhance responsible sharing of clinical trial data. The committee will identify guiding principles and characteristics for the optimal infrastructure and governance for sharing clinical trial data, taking into consideration a variety of approaches (e.g., a distributed/federated data system).

In developing the principles and framework and in defining the rights, responsibilities, and limitations underpinning the responsible sharing of clinical trial data, the committee will take into account the benefits of data sharing, the potential adverse consequences of both sharing and not sharing data, and the landscape of regulations and policies under which data sharing occurs. Focused consideration will also be given to the ethical standards and to integrating core principles and values, including privacy. The committee is not expected to develop or define specific technical data standards.

A discussion framework will be released for public comment, which will include tentative findings regarding (a) guiding principles and (b) a selected set of data sharing activities. Based on the public comments received and further deliberations, the committee will prepare a final report with its findings and recommendations.

Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
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BOX 1-2
Key Definitions

For the purposes of this study, interventional clinical trials are defined as “research in which participants are assigned to receive one or more interventions (or no intervention) so that the effects of the interventions on biomedical or health-related outcomes can be evaluated. Assignments to treatment groups are determined by the study protocol” (ClinicalTrials.gov, 2012). An intervention is a “process or action that is the focus of a clinical trial. This can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available” (ClinicalTrials.gov, 2012). For the purposes of this study, intervention types are limited to drugs, devices, biologics, surgical procedures, behavioral interventions, and changes in the administration or delivery of clinical care. The committee further found it useful to consider interventional 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* from scientific research available for secondary uses. This report distinguishes between primary and secondary uses of data. The former include analyses addressing research questions the trial was originally designed to address; these questions would be delineated in the analysis plan that is registered prior to enrollment of the first participant. The latter include (1) reanalyses of questions addressed in the primary uses to check for replicability/validity, (2) meta-analyses, and (3) de novo analyses designed to address questions the trial was not explicitly designed to address. Data may be shared either proactively (e.g., by posting to a website or providing to a repository) or upon request.

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* Many different types of data may be shared, including individual participant data (i.e., raw data and the analyzable data set); metadata, or “data about the data” (e.g., protocol, statistical analysis plan, and analytic code); and summary-level data (e.g., summary-level results posted on registries, lay summaries, publications, and clinical study reports). See Chapter 4 for the committee’s analysis of the benefits and risks of sharing different types of data.

other relevant issues. As specified in the statement of task (see Box 1-1), the scope of the study was limited to interventional clinical trials (see the definitions in Box 1-2).

STUDY APPROACH

Study Process

During the course of its deliberations, the committee gathered information through a variety of mechanisms: (1) three 1.5-day face-to-face workshops held in Washington, DC, in October 2013, February 2014,

Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×

and May 2014 and one virtual workshop held in April 2014, all of which were open to the public (see Appendix A for the workshop agendas and speaker information); (2) release in January 2014 of the Framework document, which invited public feedback on a set of issues relevant to this report and is described in greater detail in the section below; (3) reviews of the scientific literature and commissioning of two papers on special topics—the de-identification of clinical trial data (see Appendix B) and drug regulation in selected developing countries5; and (4) personal communication between committee members and staff and individuals who have been directly involved in or have special knowledge of the issues under consideration.

Framework for Discussion and Public Feedback

In accordance with the study charge, the Framework was publicly released in January 2014. 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. The committee invited comments on a set of difficult issues that were likely to be complex and on which stakeholders were likely to have differing perspectives (see Appendix A).

In addition to the public release of the Framework, several medical journals—including the New England Journal of Medicine, the British Medical Journal, and the Journal of the American Medical Association—wrote editorials or otherwise published on the committee’s work and encouraged their readership to send comments (Drazen, 2014; Kuehn, 2014; McCarthy, 2014). In response to these efforts, the committee received 85 written comments from a variety of individuals and organizations, including academic researchers from across the globe, industry representatives (pharmaceutical, device, and biologic from both individual companies and trade associations), clinicians and health care organizations, patient/disease advocacy representatives, and others (a complete list of these individuals and organizations is provided in Appendix A). IOM staff collected and compiled all comments for the committee’s review, calling particular attention to cross-cutting themes and unique perspectives.

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5 The commissioned paper “The Interaction Between Open Trial Data and Drug Regulation in Selected Developing Countries” was used by the committee in support of its analysis in this report. This paper is available on this report’s website (www.iom.edu/datasharing).

Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
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Formulation and Applicability of the Committee’s Recommendations

Sharing of clinical trial data is a relatively new and evolving field, with a limited evidence base in the scientific literature. Consequently, although the committee drew on the literature when possible, its conclusions and recommendations were formulated largely on the basis of knowledge gained through its extensive information gathering process, as described above, as well as its members’ own expertise.

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 improvement, behavioral interventions, and health care delivery modifications as well as drug trials;
  • trials carried out in resource-poor settings, where unfunded mandates 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.

Additionally, as a result of advances in methods and technology, the way clinical trials are conducted is undergoing a major transformation (Munos, 2014), and clinical trials are likely to continue to change dramatically:

  • Trials will increasingly collect patient-centered data directly from participants and from personal sensors, social media, and other digital information technologies (IOM, 2013a; Munos, 2014).
  • Trials will progressively use electronic health records as data sources, for example, to assess simple clinical endpoints in large pragmatic trials (IOM, 2013a; Munos, 2014).
  • Many trials will be embedded into clinical care. Examples include quality improvement and prevention trials, prompted optional randomized trials (PORTs) (e.g., trials using point-of-care randomization), and n-of-1 studies (Flory and Karlawish, 2012; Pletcher et al., 2014).
  • Innovative clinical trial designs are increasingly being used, including adaptive designs (e.g., stepped wedge, PORTs).
Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
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  • Also likely are more hybrid methodology trials (i.e., those that collect both quantitative and qualitative data).
  • Citizen-scientists and patient advocacy groups will become active collaborators with traditional sponsors in designing and implementing clinical trials.

Policies regarding responsible sharing of clinical trial data will need to take these new developments into account. For example, data collected from clinical care and from personal devices and sensors will present additional opportunities for secondary research but also new challenges regarding consent and sharing of private and identifiable data. 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. Informed by these principles and the committee’s consideration of the various sources of information detailed above, Chapters 3 through 5 address the “who, what, when, and how” of data sharing. Chapter 3 addresses the question of “who.” It identifies the stakeholders in clinical trials, their roles and responsibilities with respect to the clinical trials enterprise, and the benefits and risks of data sharing from their perspectives. In this chapter, the committee recommends actions each stakeholder could take to help foster a culture in which data sharing is the expected norm. Chapter 4 articulates professional and community standards for “what” data should be shared and “when” in the clinical trials process. Chapter 5 addresses the question of “how” these data should be shared. It presents various approaches for controlling access to data, ranging from less to more restrictive, and explores their associated implications. Throughout Chapters 4 and 5, the committee delineates the salient benefits and risks associated with sharing different types of data at different timepoints and under various conditions; this discussion serves as the foundation for the committee’s conclusions and recommendations in these two chapters. Finally, Chapter 6 presents a vision for data sharing based on the discussion in the preceding chapters and outlines remaining challenges that need to be addressed before this vision can be realized. This chapter offers the committee’s

Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
×

recommendation for beginning to address these challenges and moving forward.

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Suggested Citation:"1 Introduction." Institute of Medicine. 2015. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: The National Academies Press. doi: 10.17226/18998.
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Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health.

Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs.

Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research--from funders, to researchers, to journals, to physicians, and ultimately, to patients.

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