FDA’s OND Issues Annual Report Highlighting Innovative Trial Designs

The FDA’s Office of New Drugs (OND) provides a look into its work with stakeholders to support innovative trial designs in 2021, in its latest yearly report.

For example, through its Complex Innovative Trial Design program, OND provided feedback last year on several trial designs for serious diseases like systemic lupus erythematosus. It also worked closely with stakeholders on trial designs to evaluate potential COVID-19 therapy candidates, including innovative approaches to hasten trial operations and cut costs.

The innovations “enabled the launch of new drug development programs, the inclusion of previously underrepresented patient populations in clinical trials that might otherwise have been impracticable, the use of real-world data to inform new trial designs and support the approval of treatments, guidance on clinical trials for transdermal delivery of drugs, and guidance on consumer behavior studies to expand the nonprescription drug market, to name a few,” OND said.

Read the full report here: bit.ly/3OAQJvn.