Changing with the times
In early 2000, when the US FDA recognised that increased spending on biomedical research does not necessarily reflect an increase of the success rate of pharmaceutical development, the organisation kicked off the Critical Path Initiative to assist sponsors not only to diagnose the scientific challenges underlying medical product pipeline problems, but also to identify solutions to bridge the gap between the quick pace of new biomedical discoveries and the slower pace at which those discoveries are currently being developed into therapies. The use of advancing innovative trial designs is identified as one of the top opportunities for streamlining clinical trials, not only to increase the probability of success, but also to expedite the biopharmaceutical development process. The potential use of adaptive design methods in clinical trials has been discussed in detail within the pharmaceutical and biotech industries and regulatory agencies since then.
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