Gottlieb: FDA To Move Away From Traditional Trials, Foster Computational Modeling

FDA Commissioner Scott Gottlieb said the agency is taking steps to make the clinical trial process smoother and less costly for sponsors, including: embracing seamless trial designs, which abandon the traditional three phases of trials; using master protocols; and relying on advanced computational modeling. Gottlieb said these moves are part of his commitment to lowering drug costs by increasing competition. The commissioner also announced the agency will engage with stakeholders, particularly with regard to computational modeling by: issuing guidance, conducting...