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Vivli comments on NIH Data Sharing Policy

The NIH asked for public input on a NIH data management and sharing policy proposal.

Full details on the DRAFT NIH Policy for Data Management and Sharing and the Supplemental DRAFT guidance can be found here.

Below are the comments that Vivli submitted.

As the world’s largest funder of research, NIH has a major leadership opportunity to significantly impact data sharing by updating and aligning its data sharing policy with contemporary best practices. Sadly, this recently issued draft policy does not reflect the major step forward we had hoped for, but is simply an incremental change over the last policy.

Vivli is a non-profit organization founded in 2018 that manages the world’s largest clinical trial data sharing platform. We provide a single point of search and request to participant-level data from over 4700 trials representing 2.2 million participants from 109 countries. Our comments are restricted to clinical trial data sharing, which we believe has the broadest and most immediate impact on advancing human health by accelerating new findings through data reuse. Moreover, clinical trial data sharing also respects trial participants’ assumption of personal risk to contribute to science by maximizing the value of their contributions.

The plan as currently drafted is significantly weakened by choosing “deliberate flexibility” over a robust and clear mandate for clinical trial data sharing. Typically, flexibility in the conduct of science is a benefit; however, in this instance this approach significantly weakens our accountability to participants. We recommend at a minimum that the following be mandated elements within the data sharing plan with respect to clinical trials data rather than “flexible” elements managed at the discretion of the investigator:

  • The current proposal leaves open the timeframe for when data would be made available to users at the discretion of researchers. We recommend that NIH funded clinical trials require reporting of individual participant-level data (IPD) to an approved repository within a reasonable time period. The National Academy of Medicine Report has suggested a practical timeframe of 18 months post-trial completion.
  • The current proposal does not bind clinical trial proposals to declare a particular trial repository in the data sharing plan. We strongly recommend that NIH establish clear standards, criteria and best practices for clinical trial data sharing repositories, maintain a list of these approved repositories, promote awareness among researchers of this list, and require investigators to declare which approved repository they will be using.
  • For clinical trial proposals, NIH should institute a requirement that demonstrates a rigorous search of prior relevant summary and IPD results in the research plan section. This would ensure that duplicative trials are not initiated, and we are respecting our participants contributions by leveraging them to the fullest.

In conclusion, Vivli strongly supports mandatory data sharing for clinical trial proposals. Investigators who that do not meet minimum thresholds should have direct measurable rewards and consequences based on their data sharing performance. Perhaps the single most impactful change to the current draft policy would be to score the data sharing plan during the grant review process and ensure that this score impacts the funding decision. We have waited for 15 years for this important update to the NIH’s data sharing policy. As this new policy lacks any effective mandate for sharing of clinical trial data, it in effect relinquishes NIH’s responsibility to the research community, researchers and patients. This incremental proposal if enacted would signal to researchers that clinical trial data sharing is a voluntary endeavor, which breaks trust with trial participants’ strong desire to share. We can do better.

NIH is in the enviable position of being able to alter incentives and investigator behavior in ways to produce lasting changes for future generations of patients if this proposal is crafted carefully. We appreciate the opportunity to share our perspective, and we urge the NIH to consider our suggestions carefully in the next draft of its data sharing policy and to lead in clinical trial data sharing.