Report calls for transparency in clinical trial data

Washington, DC-The Institute of Medicine (IOM) recently released a report that called for increased sharing of clinical trial data in order to advance scientific discovery and avoid duplicate trials.

IOM assembled a committee with the support of 23 public and private sector sponsors to develop guidelines and a practical framework for the sharing of clinical trial data.

“Although clinical trials generate vast amounts of data, a large portion is never published or made available to other researchers,” the report’s authors write. “Data sharing 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.”

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The report also acknowledges the significant risks and challenges that come with sharing clinical trial data and says policies will be needed to protect the privacy of trial participants, the investments of sponsors, the academic efforts of the investigators, and the validity of the analyses. 

“If honesty is the best policy, full disclosure is clearly a best practice,” says Art Epstein, OD, FAAO, who is in private practice in Phoenix. “While complete disclosure of study findings bears some commercial risk for drug and device manufacturers, the potential benefits of increased transparency justify adoption of this practice as a standard.”   

The committee created the following guiding principles for the sharing of clinical data:

• Maximize the benefits of clinical trials while minimizing the risks of data sharing

• Respect individual participants whose data are shared

• Increase public trust in clinical trials and the sharing of trial data

• Conduct the sharing of trial data in a fair manner

“Sharing clinical trial data has the potential to benefit patient care as well as future research,” says Optometry Times Editorial Advisory Board member Danica Marrelli, OD, FAAO, clinical associate professor at the University of Houston College of Optometry.  “I'm sure there will be some challenges associated with the implementation of the data sharing, but I support IOM's guidelines.”

Next: Timing of data sharing

Timing of data sharing

The committee identified the optimal stage in the clinical trial lifecycle at which each data type-including individual participant data, metadata, and summary-level data- and under what kinds of conditions. The report said that the timing of the data sharing should be based on several goals:

• To allow a fair opportunity for those conducting the clinical trial to publish results before secondary investigators gain access to the data

• To allow secondary investigators to access unpublished trial data after a fair period has passed or reproduce the findings of a published analysis

• To protect the commercial interests of sponsors in gaining regulatory approval for a product so that they receive fair financial rewards for their investment

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The committee concluded that 18 months would be enough time for the original investigators to conclude their analyses. After that time period, regardless of whether the results of the clinical trial had been published yet, the committee says other investigators should have access to the data. The committee does make an exception for trials that are part of a submission to a regulatory agency for approval, but says that the data should be shared no later than 30 days after regulatory approval or 18 months after product abandonment.

The committee also recommends that the supporting analytic dataset from a clinical trial published within the 18-month deadline should be shared within six months of publication.

According to the IOM report, each of these deadline recommendations would act as professional standards, rather than hardline rules because the committee recognized that there would be many trials that would be necessary exceptions. 

Next: Controlling access to the data

Controlling access to the data

There are a number of obvious risks associated with granting access to all clinical trial data, but the committee decided those risks could largely be avoided by controlling who could access the data and under what conditions they could do so.

In general, the committee recommends open, public access to the data as long as all of the stakeholders are comfortable with doing so. But there will be cases in which the stakeholders may have concerns, and for that, the committee recommends a case-by-case review of data access requests by independent panels that include representatives from the community, patient, and disease advocacy groups to ensure transparency policies.

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Challenges to sharing clinical trial data

IOM recognized there are a few barriers to safely and effectively sharing clinical trial data-including infrastructure, technology, workforce, and sustainability.

There are no platforms sufficient to efficiently store and manage the amount of trial data that would be available. And the current data sharing platforms are not consistently discoverable, searchable, and interoperable, according to the committee.

The report found that there was not an adequate workforce within the clinical trial ecosystem to manage the operational and technical aspects of data sharing. And finally, for a system of data sharing to be sustainable, the costs will need to be distributed equitably across generators and users of the data, the report says.