Increasing openness in clinical trials

[MeSci]

From Physician's First Watch.

I was particularly struck by this phrase:

participants put themselves at risk to participate in clinical trials

Although a clinical trial may help some participants gain remission from their illnesses, the main beneficiaries are the drug companies. The trials (if successful) enable the drug companies to gain a licence to market their drugs.

OTOH, the patients who take such risks may not be able to continue taking the drugs because they cannot get funding to do so, especially if, as sometimes appears to happen, the drug companies put up the price once the licence has been obtained.

Hidden Clinical Trial Data: A Dam About to Burst?
By Larry Husten
Edited by
- Susan Sadoughi, MD, and
- Richard Saitz, MD, MPH, FACP, FASAM

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

In the first, a preliminary report from the Institute of Medicine lends strong support to the open data movement. Among the IOM's recommendations: investigators should be required to establish a data-sharing plan at the time the trial is registered, and data underlying a trial analysis should be made available within 6 months after journal publication.

In the second development, the Yale University Open Data Access (YODA) Project announced that Johnson & Johnson plans to share data from its device and diagnostic trials -- a first in the field. (J&J previously announced plans to share data from its drug portfolio.)

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 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."

Link(s):
Institute of Medicine report (Free) http://click.jwatch.org/cts/click?q=227;68125318;1JYDVYywKbpFqXw+eUC8W+Kd5f3QO+g2qAcjoMbJqQg=
YODA website (Free) http://click.jwatch.org/cts/click?q=227;68125318;1JYDVYywKbpFqXw+eUC8W2fOku7GBwsTqAcjoMbJqQg=
NEJM perspective (Free) http://click.jwatch.org/cts/click?q=227;68125318;1JYDVYywKbpFqXw+eUC8W5IRmQ1sMzR5qAcjoMbJqQg=
Background: Physician's First Watch coverage of Johnson & Johnson sharing clinical trial data (Free) http://click.jwatch.org/cts/click?q=227;68125318;1JYDVYywKbpFqXw+eUC8WyO7aBh9mfchqAcjoMbJqQg=