Monday, October 14, 2013

Don't Keep Clinical Trial Adverse Events Data Secret!

Drug company attempts to repress open dissemination of Clinical Study Reports by the European Medicines Agency are quite shortsighted. In addition to the obvious public benefit of providing comprehensive safety data to academic researchers, the transparent approach would be of value to the drug companies themselves. One of the major factors in the high cost of new drugs is the expense involved in failed late-stage clinical trials.  In many cases several companies will conduct trials on similar medications with each trial being veiled by corporate secrecy. In contrast, prompt dissemination of full CSRs could prevent late entrants into a therapeutic field from making the same mistakes in trial design as earlier entrants. While this might be perceived as rather negative for the pioneer in any particular case, over time the advantages would average out to the benefit of the entire industry. Surely steps can be taken to protect key intellectual property involved in clinical trials while still disseminating important information on adverse events. The EMA is very forward looking on this issue; one would hope that the FDA would follow, but don’t count on it!

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