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Why Do Drugs Fail?
SummaryThis report analyses recent drug failure events and examines potential areas of remedy for regulators and companies. Greedy companies being economical with the truth? Overzealous regulators pursuing political agendas? Poorly designed or inconclusive clinical trials? Whatever your view, the failure of a drug late in its development or, worse still, post-launch hurts. It hurts the developer commercially, it hurts the credibility of the regulator, it hurts those patients who are able to benefit from it and it undermines confidence in the industry as a whole. Statistics may indicate that the rate of drug approval failure hasn't increased, but there has been a succession of failures and withdrawals, some of them very high profile, which have knocked profits, investment and confidence. What can be learnt from these events and what action can the industry and regulators take to improve their performance in this critical area?
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