# 195 - Clinical Trial Design, Oncology Innovation & Decentralized Trials with Archana Sah

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2025-07-02
- Length: 47m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-02-195-clinical-trial-design-oncology-innovation-decentralized-trials-with-archana
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/195---Clinical-Trial-Design--Oncology-Innovation--Decentralized-Trials-with-Archana-Sah-e34vlav

## Summary

Archana Sah, a clinical development thought leader with 30 years of experience at companies including Genentech/Roche, Bayer, and Medable, explains the rigorous design of oncology clinical trials, emphasizing the shift from placebo to standard-of-care comparators and the critical role of patient diversity. She details the evolution toward Decentralized Clinical Trials (DCTs) and the use of digital health technologies to overcome enrollment barriers and address historical mistrust in medical research. Sah argues that while DCTs introduce complexity for sponsors, they are essential for enrolling diverse populations, provided they are deployed in a 'fit for purpose' manner that balances data integrity with patient burden.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-02-195-clinical-trial-design-oncology-innovation-decentralized-trials-with-archana#t=0) Introduction: Archana Sah and Clinical Trial Fundamentals
- [0:55](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-02-195-clinical-trial-design-oncology-innovation-decentralized-trials-with-archana#t=55) Phases of Clinical Trials: Safety, Efficacy, and Standard of Care
- [9:35](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-02-195-clinical-trial-design-oncology-innovation-decentralized-trials-with-archana#t=575) Oncology Patient Pathways and Standard of Care Guidelines
- [19:13](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-02-195-clinical-trial-design-oncology-innovation-decentralized-trials-with-archana#t=1153) Trial Designs: Basket, Umbrella, and BA/BE Studies
- [26:07](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-02-195-clinical-trial-design-oncology-innovation-decentralized-trials-with-archana#t=1567) Addressing Mistrust and the DEPICT Act for Diversity
- [26:59](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-02-195-clinical-trial-design-oncology-innovation-decentralized-trials-with-archana#t=1619) The Rise and Reality of Decentralized Clinical Trials
- [42:47](https://hardwarepodcasts.com/podcast/lets-combinate/2025-07-02-195-clinical-trial-design-oncology-innovation-decentralized-trials-with-archana#t=2567) Technology, Regulation, and Fit-for-Purpose Deployment

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Connected products & IoT](https://hardwarepodcasts.com/topic/connected-products-and-iot)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Careers & education](https://hardwarepodcasts.com/topic/engineering-careers-and-education)

## Most relevant to

large enterprises

## Mentioned

- Genentech/Roche (company)
- Bayer (company)
- Johnson & Johnson (company)
- ICON (company)
- Medable (company)
- Tecentriq (product)
- Alecensa (product)
- Polivy (product)
- Hemlibra (product)
- Gazyva (product)
- FDA (other)
- EMA (other)
- Tufts University (company)
- AstraZeneca (company)

## Related episodes from other shows

- [#373: Creative Clinical Recruitment](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-06-06-373-creative-clinical-recruitment) (Global Medical Device Podcast)
- [#332: Regulatory Strategy and the Advantage of Diversity in MedTech](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-08-17-332-regulatory-strategy-and-the-advantage-of-diversity-in-medtech) (Global Medical Device Podcast)
- [Managing Clinical Data Activities](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-07-managing-clinical-data-activities) (Global Medical Device Podcast)
- [#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)
- [#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)

## Citing this page

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