Season 8 Episode 9 : Exploring Clinical Trials & FDA Approvals with Dave Hughes

The PQI Podcast

In this episode, we’re joined by Dave Hughes, PharmD, BCOP, MPH, Senior Medical Director at Pfizer, who shares his expertise on the clinical trial landscape. With years of experience in oncology research and clinical pharmacy, Dave breaks down the key phases of clinical trials—from early-stage safety assessments to confirming effectiveness in large populations. Understanding these phases is essential for anyone involved in the drug development process.

Dave also delves into the growing role of real-world evidence, which offers valuable insights into how therapies perform in everyday clinical settings, complementing traditional clinical trial data. He discusses how FDA approval pathways, such as fast track, breakthrough therapy, and accelerated approval, are designed to expedite access to life-saving therapies.

We also explore the future of clinical trials, from AI and machine learning’s transformative impact on research to the evolving strategies that will shape patient care. Finally, Dave addresses the common misconception that clinical trials are only available as a last resort, emphasizing that they offer early access to cutting-edge treatments throughout a patient’s journey.

Disclaimer:
The views and opinions expressed in this episode are solely those of our guest, Dave, and do not represent the official stance, policies, or views of Pfizer, NCODA, or any other organization. This discussion is for informational purposes only and should not be considered medical or regulatory advice. Always consult with regulatory authorities for official guidance.