Delay in licensing drugs costs lives
Licensing authorities require that drugs have a clinically meaningful
effect, and in the case of anticancer drugs this is taken to mean an
increase in survival compared with standard treatment. However, waiting
for these clinical endpoints poses a dilemma, as the introduction of a
potentially valuable drug may be delayed considerably. Koopmans
(p 1389) argues that other endpoints and quality of life data should
be used and that the effect on survival could be investigated after the
drug is marketed.
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- Clinical endpoints in trials of drugs for cancer: time for a rethink?
- P P Koopmans
BMJ 2002 324: 1389-1391.[Extract] [Full Text] [PDF]
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