FDA’s 2021 Clinical Trial Regulatory Plan Focuses on Diversity, Complex Design
The FDA’s plan for regulating clinical trials in 2021 will focus on increasing participant diversity, encouraging complex and innovative trial designs, and qualifying new drug development tools.
The FDA said it will pursue efforts to advance the use of complex innovative trial designs (CID), including complex adaptive and Bayesian trial designs. The FDA will continue to administer the CID Pilot Meeting Program to help sponsors using complex designs increase their interaction with FDA staff and improve clinical trial efficiency.
Another topic of interest to the FDA is improving the use of agency-endorsed drug development tools, such as biomarkers and clinical outcomes assessment tools.
Read the report at https://bit.ly/2Lr24Db.