Combi Crumbs: Clinical Trials 101 – From Safety to Strategy

Let's Combinate - Drugs + Devices

From Episode 195 with Archana Sah

In this clip of the larger interview with Archana Sah, she covers the critical phases and elements of clinical trials—from phase one focusing on safety to phase three assessing effectiveness in diverse populations. Key aspects include the importance of the trial design, the role of comparator arms, regulatory requirements, patient recruitment, and the cultural preferences that influence trial protocols. The episode provides an in-depth look at how data is collected and analyzed to ensure the safety and efficacy of new drugs.00:00 Introduction to Clinical Trials00:26 Phases of Clinical Trials02:09 Designing Oncology Trials04:00 Protocol Design and Regulatory Approval05:27 Patient-Centric Considerations06:25 Vendor Roles and Statistical Analysis