APhA-ASP Proposal 2005.2 Clinical Trials

APhA-ASP encourages legislation that requires pharmaceutical manufacturers and researchers to disclose the results of all clinical trials regardless of outcome through an independently reviewed, publicly accessible, national electronic database.

Background Statement:
Clinical studies with positive findings are more likely to be published than negative studies or studies that are inconclusive. Over the past year, questions about the availability of studies revealing adverse effects have emerged. This raises the concern that the pattern of publication distorts medical literature and ultimately affects decisions made by health care professionals. Although some drug manufacturers have offered to make the results of clinical trials available to the public, it is currently not required. Therefore, we feel it is necessary for legislation that requires all clinical studies, regardless of outcome, conducted by drug manufacturers, academic researchers, and other independent research facilities be compiled in an independently reviewed national electronic database. Such a database would ensure standardization of data, results and information. This database should be made available to both health care providers and to the public.

As an American, I have a right to disclose anything I want. The same should be afforded to drug companies. If they created a drug and it killed everyone on the trial, obviously it will be D/C'ed but no need to create a mass hysteria by releasing that result!