Open Access News

News from the open access movement


Friday, April 21, 2006

Defending OA to clinical trial data

Matthew James Cockerill and Melissa Norton, Assessing Clinical Trial Results, Science Magazine, April 21, 2006. A letter to the editor. Cockerill and Norton are both from BioMed Central. Excerpt:
In her policy forum "Clinical trials results databases: unanswered questions" (13 Jan., p. 180), C. B. Fisher warns of several undesirable effects that might result from open access to raw data from clinical trials. Referring to the editorial policy of a new journal, Fisher suggests that "lack of emphasis on the direction of results or size … risks diluting scientific standards for peer review."

In fact, neither the size of a trial nor the direction of its results in itself determines the trial's scientific validity. Certainly, it is vital that trials based on small numbers of participants and trials delivering negative results should not be overinterpreted. But, if properly conducted and controlled, small trials and trials with negative results can both make important contributions to medical knowledge....

Fisher also wonders whether "the availability of large bodies of data from studies that may or may not have scientific merit will improve or distract from the peer-review process." Recent events in South Korea and elsewhere strongly suggest that making additional raw data available to peer reviewers whenever possible would be desirable. While not eliminating the possibility of fraud, it would at least make it less straightforward and so, arguably, less tempting....

Any science, including published peer-reviewed research, may be abused by misinterpretation. This should not be used as a justification for hiding important data behind closed doors.