FDA, Industry Members Propose Models for Real-World Clinical Trials

Three clinical trial designs incorporating real-world evidence were proposed by a working group consisting of members the FDA and industry, who said the trials could possibly be used in future regulatory decisions.

At the Friends of Cancer Research annual meeting, the group warned that patient selection, navigating informed consent and assuring the quality of electronic records are still major issues blocking the widespread use of real-world data in clinical trials.

Real-world data from electronic medical records and other sources could be used for analyzing post-market safety, predicting biomarkers and assessing use in special populations they said.