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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