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For the past two or three years, the call for greater clinical trial data transparency has been a common one, with research ethicists pushing for tougher data reporting rules. Now, the Institute of Medicine (IOM) has weighed in with a new report, “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risks.”
The report lays out guidelines for “responsible sharing of clinical trial data,” created by a collaboration of 23 public and private sponsors from the U.S. and around the world. Research stakeholders can collaborate to share clinical trial data with outside researchers, which could “advance scientific discovery and improve clinical care by maximizing the knowledge gained from data collected in trials, stimulating new ideas for research, and avoiding unnecessarily duplicative trials,” according to the report. The report guidelines can help trial sponsors create plans for data sharing that take the context of the clinical trial and the needs of the stakeholders into account. It also gives steps for planning the timing of data release.
There are also concerns, limitations, and burdens related to this data sharing, according to the report. Privacy and security are two of the major concerns, but steps can be taken to mitigate the risk and better protect identifying data of participants, according to the report. “[T]he committee urges stakeholders to share lessons and best practices for data access policies as data sharing practices evolve,” the report states. Other challenges include insufficient infrastructure, lagging technology, inadequate workforce, and sustainable costs.
“[A] multi-stakeholder effort is needed to develop a culture, infrastructure, and policies that will foster responsible sharing—now and in the future,” the report concludes.
The push for more clinical trial data transparency came about largely due to the hesitation of clinical trial sponsors and drug companies to release greater amounts of data, citing worries about trade secrets. But a few drug companies, such as GlaxoSmithKline, Pfizer, and Johnson & Johnson, are making more of an effort to release more trial data to outside researchers through avenues such as Yale University’s Open Data Access Project (YODA). While the IOM committee’s report will give the call for data a bigger boost, other drug companies and clinical trial sponsors may still be reluctant to let it all – or even some of it – hang out.