Watch Gottlieb's speech where he outlines the steps FDA is taking to modernize how clinical information to make decisions about the safety/effectiveness of new drugs is being collected and evaluated. In particular he focuses on two aspects -
- Adaptive and seamless clinical trial approaches
- Better use of more advanced computing tools, and more sophisticated statistical and computational methodologies, as part of the drug development and the drug review process
Here is the transcript and a key message.
"In silico clinical trials use computer models and simulations to develop and evaluate devices and drugs. Modeling and simulation play a critical role in organizing diverse data sets and exploring alternate study designs. This enables safe and effective new therapeutics to advance more efficiently through the different stages of clinical trials. FDA’s efforts in modeling and simulation are enabled through multiple collaborations with external parties that provide additional expertise and infrastructure to advance the development of these state-of-the-art technologies.
FDA’s Center for Drug Evaluation and Research (CDER) is currently using modeling and simulation to predict clinical outcomes, inform clinical trial designs, support evidence of effectiveness, optimize dosing, predict product safety, and evaluate potential adverse event mechanisms. We’ll be putting out additional, updated guidance on how aspects of these in silico tools can be advanced and incorporated into different aspects of drug development."