The U.S. Food and Drug Administration (FDA) has created a five-year pilot program to help drug and biologic companies advance their clinical development programs.
The agency's Complex Innovative Designs Pilot Meeting Program will connect FDA staff with company representatives to discuss novel complex innovative trial designs, such as modeling and simulations to evaluate trial operating characteristics and the use of biomarker-enriched populations.
"The aim is to develop more efficient strategies to assess the safety and efficacy of medical products earlier in the development process and to adopt innovative techniques that help make clinical trials more cost-efficient and flexible, enabling innovators to advance new approaches to care," said FDA Commissioner Dr. Scott Gottlieb in a statement.
Meetings under the pilot program will be conducted through the third quarter of 2023.
