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Jill Wechsler is Pharm Exec's Washington Corespondent
Investigators and sponsors of clinical trials will have to make more detailed data available following study completion, according to a new report from an Institute of Medicine (IOM) expert panel.
Investigators and sponsors of clinical trials will have to make more detailed data available following study completion, according to a new report from an Institute of Medicine expert panel, but they will have several months to disclose individual case reports and complete data supporting registration applications. Just what data will be shared, with whom and under what terms will be specified in a data-sharing plan that sponsors will submit when they register a study on a public website.
Industry has been under increased pressure in both Europe and the U.S. to make public extensive detailed information collected during clinical trials, and the IOM advisors have produced a compromise approach that supports broad, routine data sharing, while also protecting the rights of multiple stakeholders. Data sharing is important for encouraging further research, supporting regulatory decisions, and increasing public trust in clinical research, said Bernard Lo, president of The Greenwall Foundation, who chaired the IOM committee. The main goal, he observed, is that the sharing of clinical trial data should become “the expected norm.”
The report on “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks” (available at http://www.iom.edu/Reports/2015/Sharing-Clinical-Trial-Data.aspx) maps out a series of steps that academic researchers and sponsors of commercial studies should take to enhance transparency in research. The upfront data sharing plan is an important addition to the study registration information already requried to be posted on clinicaltrials.gov or other public trial registry platform before patient enrollment begins.
Sponsors next would make summary level trial results, including lay summaries, publicly available within 12 months of study completion, as currently required for most U.S. clinical trials. More detailed data that support a journal article would be provided within 6 months of publication – if not earlier. A “full data package,” which includes the analyzable data set, protocol, statistical analysis plan and analytic code, would be “shared” no later than 18 months after study completion to allow time.
For clinical trials that support product registration with FDA or other regulatory authority, sponsors would release a “post-regulatory data package” within 30 days of approval, or 18 months after study completion, whichever occurs later. This would include all the data listed above plus the clinical study report, redacted for commercially and personal confidential information. Commercial studies that are abandoned would share this data package within 18 months – unless the sponsor licenses the product to another party.
The aim of these timeframes and disclosure requirements, Lo explained, is to enable trialists and universities to publish and get credit for research, while also protecting patient privacy. The report also seeks to reduce the risk of invalid secondary analyses by supporting sponsor use of independent panels and transparent processes for reviewing review requests for detailed data. The panel acknowledges the need for biopharmaceutical companies to be able to protect intellectual property and commercially confidential information to encourage continued industry investment in costly clinical research. Data sharing requirements should be designed to “prevent other companies from using data to gain an unfair competitive advantage,” Lo commented. At the same time, both independent investigators and commercial sponsors should design clinical trials and manage data with the expectation that data will be shared.
The IOM panel also calls on FDA and other agencies to provide guidelines and standards to help academic institutions and industry meet transparency requirements. Regulatory authorities should seek to harmonize disclosure policies, such as developing new CSR templates that omit commercially confidential information. Institutional Review Boards (IRBs) should encourage responsible and ethical data sharing, provide guidance on addressing data sharing in informed consent, and consider data sharing plans when assessing the benefits and risks of clinical trials. Investigators should address data sharing specifics in the informed consent process, and sponsors should adopt common data elements in study protocols.
Lo emphasized the need for all stakeholders – starting with the project sponsors that includes the National Institutes of Health, FDA, 18 biopharma companies and several foundations -- to collaborate on building an infrastructure for managing and sharing clinical trial data. Relying on pharmaceutical companies to underwrite the cost of such a system “is not a fair model,” he stated, noting that all parties that benefit from clinical trial data sharing should bear some of the cost.
Users of disclosed research data also have obligations, notes panel member Jeffrey Drazen, editor-in-chief of the New England Journal of Medicine. In a NEJM perspective (Jan. 15, 2015), Drazin advises data recipients to credit the data source in their analyses and to clarify why their conclusions may differ from previously published results. The end goal, he notes, is to turn the data provided by “self-less volunteers” into broader applicable knowledge.