Resilience Framework in Clinical Trials

2024-01-05 Our hosts Amir Kalali, Craig Lipset, and Jane Myles were joined by Aditi Hazra with Harvard Medical School for a compelling discussion around implementing resilience framework in clinical trials.

Several references were discussed during the episode from the FDA and EMA.

1) FDA-2023-D-3550: “Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies”

https://www.federalregister.gov/documents/2023/09/21/2023-20474/considerations-for-the-conduct-of-clinical-trials-of-medical-products-during-major-disruptions-due

2) European Medicines Agency: https://www.ema.europa.eu/en/impact-war-ukraine-methodological-aspects-ongoing-clinical-trials-scientific-guideline

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