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.
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/
Dr. Simrit Parmar, founder of Cellenkos, joins the show to discuss her journey from the lab to the biotech startup world, detailing the inspiration behind launching her company, the challenges of securing funding, and the resilience required to overcome rejections. She shares insights into Cellenkos’ lead product, its progress toward market approval, and the rigorous
Carol Rausch—a healthcare professional, cancer researcher, and former patient with lymphoma—shares how her journey from researcher to patient transformed her understanding of medical language. She discusses the impact of word choice on patients, why certain battle and war metaphors can be harmful, and how language used in clinical settings differs from what resonates with those
Drs. David Braun and Toni Choueiri join to discuss a groundbreaking Nature study on a personalized neoantigen vaccine for adjuvant renal cell carcinoma. They explore the inspiration behind the trial, how the vaccine was developed and administered, and its safety profile. The conversation also covers patient outcomes after 3-4 years, including immune responses and disease
