# Combi Crumbs: Clinical Trials 101 – From Safety to Strategy

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-07-12
- Length: 8m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-12-combi-crumbs-clinical-trials-101-from-safety-to-strategy
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/Combi-Crumbs-Clinical-Trials-101--From-Safety-to-Strategy-e35eggs

## Summary

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.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-12-combi-crumbs-clinical-trials-101-from-safety-to-strategy#t=0) Introduction to Clinical Trials
- [0:26](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-12-combi-crumbs-clinical-trials-101-from-safety-to-strategy#t=26) Phases of Clinical Trials: Safety to Efficacy

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Hiring & workforce](https://hardwarepodcasts.com/topic/hiring-and-workforce)

## Most relevant to

large enterprises

## Mentioned

- FDA (other)
- EMA (other)
- PMDA (other)

## Related episodes from other shows

- [#338: Site Selection for Clinical Trials](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-06-338-site-selection-for-clinical-trials) (Global Medical Device Podcast)
- [#373: Creative Clinical Recruitment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-06-06-373-creative-clinical-recruitment) (Global Medical Device Podcast)
- [Addressing Clinical Trial Challenges & Concerns during COVID-19](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-07-29-addressing-clinical-trial-challenges-concerns-during-covid-19) (Global Medical Device Podcast)
- [#419: Essential Strategies for CRO Success in Today's Clinical Landscape](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2025-08-11-419-essential-strategies-for-cro-success-in-todays-clinical-landscape) (Global Medical Device Podcast)
- [#342: Planning an FDA Submission](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-11-02-342-planning-an-fda-submission) (Global Medical Device Podcast)

## Citing this page

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