Improving the Next Generation of Drugs Through Patient-Centric Design for Clinical Trials

December 26, 2019

(STAT News) – 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 and safety, but also by taking into consideration the broader needs of patients as individuals.