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Review: Sharing Clinical Trial Data 2/2

18. october 2015 at 8:00 | Veronika Valdova, ARETE-ZOE |  Risk Management
Key stakeholders in clinical trials include participants, research Ethics Committees, Data Monitoring Committees (DMCs/DSMBs), disease advocacy organizations, funders and sponsors of trials both non-profit and the industry, regulatory agencies, investigators including secondary analysts, research institutions and universities, journals and professional societies (p 48). Jurisdictional differences in protection of personal data can also be a concern, especially in Europe (p 52). Funders and sponsors have significant leverage to set standards and to encourage data sharing for the trials they fund (p 58). Specific examples of effects of secondary analyses are discussed in the context of conflict of interest of different stakeholders (pp 65-67).

U.S. regulatory agencies have to maneuver within the constraints of the Freedom of Information Act (FOIA), the Trade Secrets Act (TSA), and 21 CFR 20.61(c) which makes information submitted or divulged to the FDA unavailable for public disclosure (p 70). Some legal scholars have argued that the FDA potentially has the power to disclose trade secrets for public health reasons, citing the Hatch-Waxman Act (p 71). The first recommendation of the Committee says:

"Stakeholders in clinical trials should foster a culture in which data sharing is the expected norm, and should commit to responsible strategies aimed at maximizing the benefits, minimizing the risks, and overcoming the challenges of sharing clinical trial data for all parties" (p 80).

Publication in scientific journals is the primary method for sharing clinical trial data with the scientific and medical communities. These publications, however, contain only a small subset of the data. In trials that are not part of a regulatory submission, detailed clinical study reports may or may not be prepared (p 91). The committee acknowledges that no single body or authority in the global clinical trials ecosystem has the power to enforce clinical trial data sharing (p 92).

Chapter 4 scrutinizes in thorough detail what kind of data is produced in different type of trials, and how practical (or impractical) it is to share raw data, analyzable data set, clinical trial registration number and data set, full trial protocol, manual of operations, standard operating procedures, names of members of the team, Steering Committee, Clinical Events Committee, Data and Safety Monitoring Board, Data Monitoring Committee, committee charters, details of study execution, informed consent templates, included hypotheses, full statistical analysis plan (SAP), and analytic code (pp 91-105). Additional data for sharing include publications, summaries of results for registries, lay-language summaries, and clinical study reports, either in full or abbreviated form (p 105-111).

The main argument for sharing data from legacy trials is that many current treatment decisions are based on clinical trials done in the past (p 111). The second Committee recommendation states:

"Sponsors and investigators should share the various types of clinical trial data no later than the times specified below. Sponsors and investigators who decide to make data available for sharing before these times are encouraged to do so" (p 132-133).

Chapter 5 examines with whom the data are shared and under what conditions. Potential data recipients may seek access to data for a variety of purposes, which may present different potential benefits and risks: researchers, attorneys, competitors, consultants, whose clients may include investment and financing companies and research organizations, participants in the trial, journalists, disease advocacy groups, members of the public, research ethics committees, peer-review committees, data monitoring committees or educators (p 140).

The key argument in favor of open access is that removing barriers facilitates reproducibility and more rapid advancement of new knowledge and discovery, and that the accompanying risk of invalid analyses is acceptable (p 141). Main concerns are participant privacy, unfair commercial use, invalid secondary analyses, and credit for clinical trialists and sponsors (p 145). The authors also mention already existing multi-sponsor web system ClinicalStudyDataRequest for requesting clinical trial data launched in January 2014 (p 149). Committee recommendation No 3 suggests:

"Holders of clinical trial data implement operational strategies that include employing data use agreements, designating an independent review panel, including members of the lay public in governance, and making access to clinical trial data transparent" (p 157)".

There are more platforms for sharing clinical trial data, with different data access models and sufficient total capacity to meet demand. The Committee shared its vision of culture of data sharing, articulated best practices, and called for allocating the cost of data sharing among stakeholders and protections to minimize the risks (p 164). Recommendation 4 says:
"The sponsors of this study should take the lead, together with or via a trusted impartial organization(s), to convene a multistakeholder body with global reach and broad representation to address, in an ongoing process, the key infrastructure, technological, sustainability, and workforce challenges associated with the sharing of clinical trial data" (p 177).

Appendices include details on study approach, concepts and methods of study data de-identification and legal discussions of risks to industry sponsors.

The report is an essential reading for those who need to understand industry perspective. Industry generates vast majority of clinical trial data, and its primary purpose is to generate data for approval of new drugs and return on investment. A business case has to support public health perspective to incentivize data sharing.

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