Episode 148: Pitfalls of Clinical Trials – Lessons From ADAURA

Episode 148: Pitfalls of Clinical Trials – Lessons From ADAURA

Making their return to the show are Drs. Jack West and Nathan Pennell, of City of Hope Comprehensive Cancer Center and Cleveland Clinic, respectively, this time to use the ADAURA trial as a springboard to discussing pitfalls and shortcomings of modern clinical trial designs. The trio go back and forth on control arms keeping pace with standards of care, studies mandating the ability for crossovers, and appropriate endpoints for adjuvant studies. Then, they highlight underwhelming clinical trial data that have led to FDA approvals, whether ADAURA featured a “known inferior agent” and an “inferior crossover design,” and whether ADAURA proved to be an “unethical” trial, among many other points of contention.

Related Resources

Listen to Drs. West and Pennell’s previous episode on the ADAURA trial from 2021: https://chadinabhan.com/podcast/episode-19-beyond-adaura-whats-right-and-whats-wrong-with-fda-regulations/

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