Sharing Clinical Trial Data Maximizing Benefits, Minimizing Risk (2015) / Chapter Skim
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3 The Roles and Responsibilities of Stakeholders in the Sharing of Clinical Trial Data
3 The Roles and Responsibilities of Stakeholders in the Sharing of Clinical Trial Data
Pages 47-90
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From page 47... ...
Further, all stakeholders have a role and responsibility in helping to maximize the benefits and minimize the risks of data sharing for others, as well as themselves. Participants As outlined in Box 3-1, participants in clinical trials include individual patients and healthy volunteers.
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Without willing participants, sponsors and investigators would be unable to carry out clinical trials to advance science and improve clinical care. Thus, it is vital to the clinical trials enterprise that participants be respected, that trust be maintained, and that data sharing not become a barrier (and ideally that it become an incentive)
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From page 49... ...
. If concerns about data sharing make participants less willing to enroll in clinical trials, the benefits gained by the public from clinical trials will be reduced.
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For most prospective trials, however, the informed consent process provides an opportunity to obtain participants' approval for planned data sharing and to be transparent about potential future data sharing. Although the initial consent process is unlikely to provide full details of future data sharing, investigators and sponsors can explain what data will and will not be shared with the individual participant during and after the trial, as well as under what conditions data might be shared beyond the investigators' organization or research institution.
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If large numbers of people from a specific demographic, cultural, or ethnic/racial group do not participate in clinical trials, the results will not apply to that group, weakening the evidence base for clinical decisions for the group. Proponents of compound consent argue that at least initially data sharing needs to be approached cautiously (particularly with sensitive conditions and populations that are vulnerable with respect to a particular clinical trial)
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From page 52... ...
For example, European data protection laws cover only information that relates directly or indirectly to an identified or identifiable individual (Retzer BOX 3-3 International Protections for Health Data In Europe, protections for sensitive data -- typically defined as including data on health or medical conditions -- commonly require the consent of the subject prior to data access, use, or disclosure; however, there are public policy exceptions (Retzer et al., 2011)
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From page 53... ...
. Concerns About Unsanctioned Uses of Data For participants from vulnerable populations who historically were victims of unethical research, the possibility that if data sharing becomes obligatory their data will be used for purposes or by individuals or organizations they do not sanction (IOM, 2009)
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From page 54... ...
This possibility might be addressed, strengthening engagement in clinical trials, if representatives of such vulnerable populations were included in the design and implementation of trials and if effective ways of helping participants understand the benefits of data sharing and protecting the subjects of trials were developed. Research Ethics Committees Research Ethics Committees are tasked with reviewing, revising, and approving clinical investigations involving humans, with the goal of protecting research participants and ensuring they are treated ethically as a result of their participation.
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From page 55... ...
Research Ethics Committees can establish policies that allow and promote responsible sharing of individual participant data in the clinical trials they review. To this end, they can ensure that investigators discuss with research participants during the informed consent process both the prospective benefits and the risks, including privacy risks, of sharing clinical trial data.
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From page 56... ...
DMCs indirectly facilitate data sharing because they commonly ask the trial's data management and biostatistics teams to modify their presentation of data in interim reports so as to make the data clearer and more comprehensible. The DMCs' directions likely lead to improvements in data organization and presentation that are helpful not only to the clinical trial team but also to other investigators who later analyze shared data sets.
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. Furthermore, disease advocacy organizations, through online networks, have acted as a conduit for the expression of participant frustrations regarding the lack of data sharing by investigators.
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These efforts give these organizations an opportunity to influence policies and strategies so as to encourage responsible sharing of clinical trial data. Funders and sponsors Both funders and sponsors of clinical trials have significant leverage to set standards and to encourage data sharing for the trials they fund.
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From page 59... ...
First, during the Human Genome Project, NIH was a key driver of researchers' sharing of genome sequencing data soon after they discovered the sequence so that other scientists could benefit from this knowledge to make further discoveries (NIH issues genomic data sharing policy, 2014)
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. Finally, the recent NIH Genomic Data Sharing Policy sets forth the responsibilities of NIH-funded researchers for sharing genomic data (including clinical trial data)
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. The foundation supports increased transparency and sharing of clinical trial data from the research it funds by (1)
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. Industry Sponsors In the past, the culture of clinical research in industry did not include proactively sharing clinical trial data.
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Of course, clinical trial data also are generated in medical device trials. With medical devices, however, issues regarding data exclusivity, even in jurisdictions like the United States, are less clear-cut.
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and the European Federation of Pharmaceutical Industries and Associations (EFPIA) announced a commitment from all of their member companies to develop a process for and commit to sharing clinical trial data (PhRMA and EFPIA, 2013)
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THE ROLES AND RESPONSIBILITIES OF STAKEHOLDERS 65 TABLE 3-1 Examples of Effects of Independent Analyses Carried Out on Clinical Trial Data Concerns Raised by Independent Analyses of Clinical Trial Data Effects Oseltamivir • Trials with 60 percent of • Public and scientific debate patient data not reported about the decision to • Full study reports inaccessible stockpile oseltamivir as part for 29 percent of trials of pandemic preparedness • Missing modules for 16 of 17 (Godlee, 2009) available full study reports • Further reanalyses of existing • Discrepancies between clinical trial data carried out published articles and full by additional investigators, study reports with conflicting conclusions • Independent analysis showed (Cochrane Neuraminidase that oseltamivir did not Inhibitors Review Team, 2011; necessarily reduce hospital Hernán and Lipsitch, 2011a,b; admissions and pulmonary Michiels et al., 2013)
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From page 66... ...
analysis of clinical trial data • A study using health claims submitted to it showed that data showed that after the use of antidepressants in FDA issued its black-box adolescents was associated warning in 2003, use of with a mild increase in antidepressants among youth suicidality (Hammad et al., decreased by 31 percent; 2006) ; this publication was during the same period, criticized by a professor with suicide attempts involving many contracts with industry overdoses of psychotropic • Independent review in 2008 drugs increased by 22 percent showed that 94 percent of in adolescents (Lu et al., 2014)
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From page 67... ...
The EMA has been a pioneer in the sharing of clinical trial data; its 9 It is important to note that regulatory agencies in different jurisdictions differ in the types of data they hold and in what authority they have to provide access to data submitted to them or to other parties.
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• ork to create templates for informed consent forms, clinical study reports, W etc. to allow for greater data sharing • ata sharing coordinators -- independent roles assigned to manage the D intake and fulfillment of requests *
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European Medicines Agency (EMA) As noted, the EMA has been a key promoter of greater transparency in sharing of clinical trial data.
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Furthermore, critics have objected that effective masking of products would limit the usefulness of the data for secondary analyses of individual clinical trials and meta-analyses. The power of U.S.
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From page 71... ...
has authority to promulgate constitute "law." Further, some legal scholars have argued that the FDA potentially has the power to disclose trade secrets for public health reasons, citing the provision in the Hatch-Waxman Act stating that the FDA is supposed to release clinical trial data after HatchWaxman data exclusivity expires, absent "extraordinary circumstances."16 Section 301(j) of the Food, Drug, and Cosmetic Act (FDCA)
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In this report, the term trialist is used to refer specifically to researchers who design and conduct clinical trials, while investigators is used for all researchers. Among investigators, the term secondary users refers to investigators who use clinical trial data for purposes including reanalyses, novel analyses, and meta-analyses but were not involved in generating the primary data.
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From page 73... ...
Finally, it is trialists who have the understanding and expertise to interpret the trial data and give them clinical meaning. Thus, without motivated and knowledgeable trialists, the clinical trial process would come to a halt.
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From page 74... ...
Furthermore, making clinical trial data shareable could make future clinical trials more efficient in the long run because new research could build on secondary analyses of the shared data. New models for funding the sharing of clinical trial data may alleviate some concerns if the costs of sharing are spread more equitably among the various stakeholders.
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Research Institutions and Universities Universities can influence data sharing activities through infrastructure support, incentives, training, and scientific review. Infrastructure Support Academic centers typically provide infrastructure in support of investigators who conduct clinical trials and generate new data.
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Appropriate recognition of data sharing activities in the promotion process would provide incentives for sharing data and obtaining maximal value from completed trials. Other promotion-related incentives for data sharing would exist if promotion committees took into account secondary publications by others based on clinical trial data produced and shared by their faculty.
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. Although responsible sharing of clinical trial data is consistent with the goals of biomedical journals, journals in general cannot take on data sharing responsibilities that are beyond their scope of work and resources.
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From page 78... ...
As recommended in this report, these details are key to the success of any data sharing program. In addition, medical journals could help address challenges to responsible sharing of clinical trial data, particularly concerns about the usefulness and validity of secondary analyses of shared data.
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Professional societies could require that authors in their official journals follow the recommendations in this report for responsible sharing of clinical trial data and that investigators submitting and presenting abstracts at their meetings agree to do so when they publish their clinical trial findings. Members of professional societies commonly take the lead in designing and carrying out clinical trials in their specialty.
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From page 80... ...
Funders and sponsors should • romote the development of a sustainable infrastructure and p mechanism by which data can be shared, in accordance with the terms and conditions of grants and contracts; • rovide funding to investigators for sharing of clinical trial data as p a line item in grants and contracts; • nclude prior data sharing as a measure of impact when deciding i about future funding; • nclude and enforce requirements in the terms and conditions of i grants and contracts that investigators will make clinical trial data available for sharing under the conditions recommended in this report; and • und and promote the development and adoption of common data f elements. Disease advocacy organizations should • equire data sharing plans as part of protocol reviews and criteria r for funding grants; • provide guidance and educational programs on data sharing for clinical trial participants; • require data sharing plans as a condition for promoting clinical trials to their constituents; and • contribute funding to enable data sharing.
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From page 81... ...
Research Ethics Committees or IRBs should • provide guidance for clinical trialists and templates for informed consent for participants that enable responsible data sharing; • onsider data sharing plans when assessing the benefits and risks c of clinical trials; and • adopt protections for participants as recommended by this com mittee and the emerging best practices of clinical trial data sharing initiatives. Investigators and sponsors should • design clinical trials and manage trial data with the expectation that data will be shared; • adopt common data elements in new clinical trial protocols unless there is a compelling scientific reason not to do so; • explain to participants during the informed consent process − hat data will (and will not)
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From page 82... ...
Membership and professional societies should • establish policies that members should participate in sharing clini cal trial data as part of their professional responsibilities; • require as a condition of submitting abstracts to a meeting of the society and manuscripts to the journal of the society that clinical trial data will be shared in accordance with the recommendations in this report; and • collaborate on and promote the development and use of common data elements relevant to their members. references Adams, B
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From page 83... ...
2014. Guiding principles for clinical trial data sharing.
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From page 84... ...
Paper presented at IOM Committee on Strategies for Responsible Sharing of Clinical Trial Data: Meeting One, October 22-23, Washington, DC.
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2014c. Finalisation of the EMA policy on publication of and access to clinical trial data -- tar geted consultation with key stakeholders in May 2014.
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2013. Strategies for responsible sharing of clinical trial data: NIH perspective.
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. NIH issues genomic data sharing policy.
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From page 88... ...
2014. Considerations of informed consent in the discussion of clinical trial data sharing -- domestic issues.
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From page 89... ...
2014. Finalisation of EMA policy on publication of and access to clinical trial data.
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