IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data
The open sharing of clinical trial data has received a major boost from a new report by the Institute of Medicine (IOM) calling for fostering a culture to make data sharing the norm, while protecting the privacy and consent of trial participants and providing researchers with sufficient time to analyze and publish the data they collect.
Overcoming the challenges of sharing clinical trial data, which entails significant risks and burdens, should be an integral part in conducting clinical trials according to the report titled Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk.
Unlike previous industry attempts at developing piecemeal approaches to sharing clinical data, the IOM report lays out recommended guidelines about which data from a trial should be shared and when. It specifies, for example, the analytic data set that supports publication of results which should be shared no later than six months after publication. Fully analyzable data should be shared within 18 months after the study is completed or 30 days after regulatory approval.
This framework was assembled by an IOM committee with support from 23 public and private-sector sponsors that included 17 leading pharmaceutical companies, the FDA and clinical research funders including the NIH and British medical charity Wellcome Trust. In explaining the reasons for the report, the committee concluded that sharing data “is in the public interest, but a multi-stakeholder effort is needed to develop a culture, infrastructure and policies that will foster responsible sharing—now and in the future.”
Those stakeholders have roles and responsibilities for sharing the data. They include study participants, sponsors, regulators, investigators, research institutions, IRB, journals and professional societies.
Among the report’s major recommendations for which specific data should be shared before and after key periods in a clinical trial:
- Sponsors and investigators should have a plan for which clinical trial data will be shared and when by the time the first patient is enrolled.
- Sponsors and investigators should make summary-level results of the clinical trial available no later than 12 months after the study is completed.
- Within six months after a publication reports clinical trial results, the “post-publication data package,” which consists of the analytic data supporting the results and metadata, including the protocol, statistical analysis plan and analytic code, should be released.
- For studies of products or new indications approved, the “post-regulatory data package” should be shared 30 days after regulatory approval or 18 months after the study completion, whichever occurs later. This package consists of the clinical study report, redacted for commercially or personal confidential information, plus the full analyzable data set, complete protocol, statistical plan and analytic code.
- For studies of a new indication abandoned, the “post-regulatory data package” should be shared no later than 18 months after abandonment.
In a statement from PhRMA, Jeffrey K. Francer, vice president and senior counsel, said the organization supports the IOM’s efforts to identify strategies for responsible clinical trial data and sharing and looks forward to reviewing the report. “The biopharmaceutical industry is strongly committed to enhancing public health through responsible data sharing that recognizes the importance of protecting patient privacy, respects the integrity of national regulatory systems and maintains incentives for continued investment in biopharmaceutical research,” he stated.
Francer cited the July 2013 adoption by PhRMA and the European Federation of Pharmaceutical Industries and Associations (EFPIA) of Principles for Responsible Clinical Trial Data Sharing, by which members of both organizations committed to enhance data sharing with qualified researchers. They also agreed to share trial results with patient participants, enhance access to clinical study information and publish clinical trial results.
The Biotechnology Industry Organization (BIO) has not yet reviewed the IOM report in depth, but said responsible sharing of clinical trial data can help advance medical research and discovery while protecting patient privacy. BIO spokesperson Tracy Cooley said in a statement: “Responsible data sharing policies should recognize the importance of maintaining incentives to invest in biomedical research and recognize the resource constraints of small, pre-revenue enterprises.”
The IOM report includes strategies to develop infrastructure, oversight and sustainability. It lists specific actions for funders and sponsors of clinical trials, as well as detailed activities for regulatory and research oversight agencies and actions for research ethics committees/IRBs.
The three main guidelines for IRBs outline:
- Providing guidance for clinical trialists, along with templates for informed consent that include language to inform potential study participants about data sharing plans for the study they are considering participating in and to enable future data sharing
- Considering data sharing plans as a benefit in IRBs’ oversight of a study
- Ensuring protections for study participants, such as protections against re-identification, are in place as appropriate.
“They are fairly clear suggestions,” said Lindsay McNair, M.D., chief medical officer and president of consulting services for WIRB-Copernicus Group, who said she was impressed with the report’s thoroughness and the level of gravity and robustness of its conclusions.
“We are in favor of sharing clinical trial data that maximize the benefits of clinical trials, where multiple scientific groups learn from each other and there is no duplication of studies to look at a question someone else already may have answered,” said McNair. “There is stronger research subject protection in studies that maximize the use of data, and participants want to know their contributions ultimately will result in more scientific knowledge.”
While no body or authority can enforce the recommendations offered in the report, the IOM recommended the 23 sponsors of the report convene a multi-stakeholder body with global reach and broad representation to address the key challenges associated with the data sharing plan.
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