Episode 19: Beyond ADAURA: What's Right and What's Wrong With FDA Regulations?

Chadi welcomes back Jack West (@JackWestMD), MD, associate clinical professor and medical oncologist, City of Hope Comprehensive Cancer Center, and Nathan Pennell (@n8pennell), MD, PhD, thoracic medical oncologist, director of the thoracic oncology program and director of clinical research, Cleveland Clinic, to the show. The task was to break down the ADAURA trial again, but to go beyond ADUARA and explore the use of various endpoints in lung cancer and how trials should be optimally designed to assure that patients garner the benefits that they deserve. The trio uses this discussion to contextualize a debate on the FDA lowering vs raising regulation on adjuvant therapies and whether the FDA should simply make drugs available and encourage physicians to use their best clinical judgment when prescribing them. ADAURA is only one study, but there are so many lessons that can be learned from the trial that can benefit current and future trial design.View Dr. West’s JAMA viewpoint on the ADAURA trial https://jamanetwork.com/journals/jamaoncology/article-abstract/2775933View Dr. Pennell’s opposing JAMA viewpointhttps://jamanetwork.com/journals/jamaoncology/fullarticle/2775934