January 14th, 2015

Hidden Clinical Trial Data: A Dam About to Burst

Two important new developments may mean that many more researchers will soon be able to access and analyze data from many more clinical trials.

In recent years, in response to troubling and far-reaching questions about the availability and reliability of clinical trial data, reformers have called for new policies that would require drug companies and other clinical trial sponsors to provide outside researchers access to the data. The two announcements today appear to bring the open data movement closer to the tipping point.

In the first development, a preliminary report from the prestigious Institute of Medicine lends strong support to the open data movement. The IOM report states that investigators should be required to establish a data-sharing plan at the same time the trial is registered. The report includes detailed recommendations for when and how the data should be made available. Among the major recommendations: data underlying a trial analysis should be made available within 6 months after journal publication, and all data should be made available no later than 18 months after the last patient visit in the trial.

In the second development, the Yale University Open Data Access (YODA) Project announced that Johnson & Johnson is expanding its plans to share data. The company had previously announced that it planned to share data from its large drug portfolio. Now the company has announced that it will also share data from its device and diagnostic trials — a first in the field. YODA will act as “a fully independent intermediary to manage requests and promote data use,” said YODA. The project will have “full control” over the data.

The “guiding principle” of the IOM report “is that participants put themselves at risk to participate in clinical trials,” writes panel member Jeffrey Drazen, in a perspective published in the New England Journal of Medicine. “The clinical trial community therefore has the responsibility to reward that altruistic behavior by widely sharing the information gathered so that as much useful knowledge as possible can be wrought from the data.”

Says Drazen: “We need to change how we think about data. We need to view it as a community resource, much like a shared park, rather than as personal property.”

Harlan Krumholz, head of the YODA project (and editor-in-chief of CardioExchange), commented on both developments: “It is gratifying to see the IOM come out strongly for data sharing. At this point they are codifying what is an emerging consensus and unstoppable growing momentum for open science in medical research. How we ever developed a culture that favored researchers over society is a good question – but the good news now is that we are firmly on our a way to a better, more responsible scientific culture. It is no longer just the voices of those outside the power structures that are calling for change.”

A statement from the IOM notes that “no body or authority currently is capable of enforcing the recommendations offered in the report.” The committee suggests that the study sponsors — which include the NIH, the FDA, large foundations, and major pharmaceutical and biotechnology companies — “take the lead to convene a multi-stakeholder body with global reach and broad representation to address, in an ongoing process, the key challenges associated with sharing clinical trial data.” The IOM panel was chaired by Bernard Lo, president of the Greenwall Foundation.


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