Hardware Podcasts

Combi Crumbs: Clinical Trials 101 – From Safety to Strategy

Let's Combinate · 12 Jul 2025 · 8m

What this episode covers

Archana Sah, a clinical development expert with over 30 years of experience, explains the critical phases of clinical trials for drug approval. She details how Phase 1 focuses on safety and PK/PD measurements, while Phase 2 and 3 assess efficacy in diverse populations, often comparing new drugs against standard-of-care treatments in oncology. Sah emphasizes the importance of protocol design, regulatory alignment with the FDA, and incorporating patient-reported outcomes to capture the patient experience. She also discusses the logistical complexities of patient recruitment, site selection, and the role of various vendors in executing decentralized or hybrid trial models.

Most relevant to

large enterprises

Topics

Mentioned

Also
FDA, EMA, PMDA

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