Full Clinical-Trial Data Sharing Moves Closer to Reality

A January 14, 2015, report published by the Institute of Medicine (IOM)¹ walks a fine line between the competing clinical-data-sharing comfort zones of pharmaceutical companies, physician associations, patient groups, and other advocacy organizations.

The 249-page report lays out 4 recommendations for increased clinical-trial data sharing. These include suggesting a maximum 18-month lag between study completion and sharing of all the data—with some exceptions for trials being used to support a regulatory application—and no more than 6 months between study publication and sharing of the analytic data set. The other recommendations are for clinical-trial stakeholders to “foster a culture in which data sharing is the expected norm,” to “mitigate the risks and enhance the benefits of sharing sensitive clinical trial data,” and to create a framework for addressing all the challenges associated with data sharing.

“While individual stakeholders can take steps to foster clinical trial data sharing, a broad range of stakeholders must act together to build an ecosystem in which responsible data sharing is expected, flourishes and continuously improves,” concluded report-committee chair Bernard Lo, MD, of the Greenwall Foundation, New York, in a summary of the report published in JAMA.²

The Oncology Nurse-APN/PA contacted Richard L. Schilsky, MD, Chief Medical Officer of the American Society of Clinical Oncologists (ASCO), for his view of the report. He said it responds to all of the concerns ASCO president Clifford Hudis, MD, expressed in a March 2014 comment to the report committee.³

“ASCO has long recognized that increasing the availability of clinical trial data is in the public interest. We encouraged the committee to recommend harmonizing international rules on data sharing and ensuring that the framework developed is broadly applicable to all clinical trials,” said Schilsky in an email. “We support the report’s recommendations and urge the report’s sponsors to swiftly convene a group to begin developing the infrastructure and policies that will foster responsible data sharing.”

However, members of a group called AllTrials point out on their website⁴ that—other than the suggested timeframes for sharing data from trials that have been completed and/or published—there are no other hard timelines, actionable steps, or proposed penalties for noncompliance laid out by the report’s authors, which include the editor-in-chief of the New England Journal of Medicine and the chief medical officer of Johnson & Johnson.

The goal of AllTrials is to have all past and present clinical trials by both industry and nonindustry researchers registered and to have their full methods and summary results reported, without exceptions. GlaxoSmithKline (GSK) officials agreed to do so 2 years ago,⁵ and they have been true to their word. No other pharmaceutical companies have followed in GSK’s footsteps, although Johnson & Johnson last year gave data from all of its drug trials to Yale University researchers.⁶ Most companies are opting instead to comply with the much more lax data-sharing regulations from the European Federation of Pharmaceutical Industry Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhMRA).

The leaders of AllTrials know, however, that poking giants can be tricky, and hence they are opting for a softer sell.

“The IOM report is a huge step forward for medicine. And one has to accept that institutional change is often slow,” said Trevor Butterworth, in a conversation with The Oncology Nurse-APN/PA. Butterworth heads Sense About Science USA, which is championing the AllTrials initiative in the United States. “Their affirming of the value of trial registration and data sharing is a recognition that the historical moment has changed—that transparency is the new intellectual currency. And the goal of AllTrials is to persuade all pharma companies to do what GSK did.”

References
1. Institute of Medicine (IOM) Committee on Strategies for Responsible Sharing of Clinical Trial Data. IOM website. https://www.iom.edu/Reports/2015/Sharing-
Clinical-Trial-Data.aspx. Published January 14, 2015. Accessed February 2, 2015.
2. Lo B. Sharing clinical trial data: maximizing benefits, minimizing risk. JAMA. Published online January 16, 2015. Accessed February 2, 2015.
3. ASCO comments on IOM discussion framework for clinical trial data sharing. American Society of Clinical Oncology (ASCO). www.asco.org/asco-comments-iom-
discussion-framework-clinical-trial-data-sharing. Published March 26, 2014, Accessed February 2, 2015.
4. America’s Institute of Medicine says sharing data from clinical trials should “become the norm.” AllTrials. www.alltrials.net/news/americas-institute-of-medicine-says-sharing-data-from-clinical-trials-should-become-the-norm/. Published January 14, 2015. Accessed February 2, 2015.
5. GSK announces support for AllTrials campaign for clinical data transparency [news release]. London, UK. GlaxoSmithKline plc; February 2013. www.gsk.com/en-gb/media/press-releases/2013/gsk-announces-
support-for-alltrials-campaign-for-clinical-data-transpar ency/. Accessed February 2, 2015.
6. Johnson & Johnson gives clinical trial data to researchers: a “game changer.” AllTrials. www.alltrials.net/news/johnson-johnson-gives-clinical-trial-data-to-
researchers-a-game-changer/. Published January 30, 2014. Accessed February 2, 2015.