Opinion: Improving the next generation of drugs through patient-centric design for clinical trials
In developing cancer drugs, the focus has been on eradicating cancer cells and shrinking tumors. It's time to also focus on patient factors like tolerability, ease of use, compliance with…
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
