US FDA, Industry Share Early Lessons From Complex Innovative Trial Designs Program
Timelines in the CID program are tight, and sponsors should have a ‘fully baked’ trial design before heading into their first meeting with the agency, industry reps say; agency needs more simulation data from participating sponsors earlier and is working to ensure continuity for firms after the second of two meetings allowed under the program.
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US FDA says sponsors generally won’t need to publicly disclose company or product if selected for pilot, but rather elements about design of their complex trial.