Bioethicists: Consider efficacy before human trials

In a commentary published Monday in Nature, bioethicists from McGill University argued that ethics panels should consider the potential clinical efficacy of drug candidates more rigorously when reviewing proposed Phase I studies. The authors proposed creating a centralized advisory system that would combine ethical and scientific review of preclinical data.

Discussion of the data requirements to begin first-in-human studies was renewed last year after one subject died and several were others hospitalized in a Phase I study that tested the safety of a fatty acid amide hydrolase (FAAH) inhibitor (see BioCentury Extra, March 10, 2016)...