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IN HER POLICY FORUM “CLINICAL TRIALS RESULTS DATABASES: UNANSWERED

By Edited Etta Kavanagh

Abstract

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. For example, the sample size of a certain trial may be large enough to allow general conclusions to be drawn but may not have sufficient power to distinguish effects on a particular age group. By taking the raw data of several such small trials together, though, it may be possible to safely extend the conclusions beyond those of the original trials. The inclusion of results from trials with both positive and negative results is vital to such meta-analyses to ensure they are not statistically skewed. Fisher also wonders whether “the availability of large bodies of dat

Year: 2010
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