Open Access News

News from the open access movement

Tuesday, October 14, 2008

More on OA for clinical drug trial data

Jocelyn Kaiser, Making Clinical Data Widely Available, Science Magazine, October 10, 2008 (accessible only to subscribers).  (Thanks to Garrett Eastman.)  Excerpt:

Last Summer, statistician Andrew Vickers e-mailed the lead author of a paper on a large clinical trial to ask for the underlying raw data set. Vickers wanted to explore whether he could predict which patients were at risk for stroke, a side effect of the drug being tested. He got a short reply, one he has heard many times before: The data are not available. “It’s just the knee-jerk refusal to share data,” says Vickers, at Memorial Sloan- Kettering Cancer Center in New York City. Vickers wasn’t surprised by the response or the lack of explanation. But he’s become so frustrated by such experiences that he penned an essay in the New York Times in January that called for making data from cancer trials freely available. Clinical researchers should get over their reluctance to share, according to Vickers; he and some others say they should emulate basic researchers who routinely deposit gene sequences in GenBank. “We need an attitude shift,” Vickers says.

Change is happening, in fact, on two fronts. Starting last month, a law enacted in 2007 will require sponsors of all clinical trials of drugs and devices that were subsequently approved in the United States to post summary results in a federal database. The aim is to ensure that all findings see the light of day, including negative results that often get buried. At the same time, the National Institutes of Health (NIH), which ramped up its data-sharing efforts with genome data more than a decade ago, has
been advancing these policies into clinical research....

[Vickers] thinks journals should encourage cooperation by requiring that clinical data sets be freely available. Although many biomedical journals have a general data-sharing policy, apparently only one —the Annals of Internal Medicine— has an explicit requirement for technical studies. Since April 2007, it has asked all authors to include a “reproducible research” statement explaining whether they will provide the study protocol, data set, and statistical code....

PS:  For background, see our past posts on OA for clinical drug trail data, and in particular, our past posts on the new federal law mandating it, the Food and Drug Administration Amendments Act of 2007 (FDAAA).