STAT December 26, 2019
When a process works, it’s natural to try to repeat it rather than recreate or rethink it. This holds true in running clinical trials to develop new drugs: the main path to FDA drug approval is often the same path that led to the prior drug’s approval.
For decades, the foundational basis for determining if a drug should be approved is whether its benefits outweigh its known and potential risks for the intended population. At its core, this is a quantitative risk-benefit analysis. It is not a patient-centric evaluation and it does not emphasize individual patient quality of life as a significant factor.
It’s time to start shifting this strategy and instead approach drug development not only through balancing efficacy...
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