# 038 - "Clinical Trials" with Dan Sfera

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-06-22
- Length: 1h 13m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-22-038-clinical-trials-with-dan-sfera
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/038---Clinical-Trials-with-Dan-Sfera-e1k90r6

## Summary

Dan Sfera, founder of Yuma Clinical Trials and author of the Comprehensive Guide to Clinical Research, explains the operational realities of clinical trials, highlighting the conflict between 'patient-centric' technology and actual patient burden. He details the high screen-failure rates in Phase 2 and 3 trials, the critical role of the Investigator's Form 1572, and the specific risks of investigational product mix-ups during randomization. Sfera also discusses the dynamics between sponsors, CROs, and sites, arguing that direct sponsor involvement often yields better outcomes than using rigid CROs.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-22-038-clinical-trials-with-dan-sfera#t=0) Introduction: Dan Sfera and Yuma Clinical Trials
- [3:18](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-22-038-clinical-trials-with-dan-sfera#t=198) Sfera's Background and the Origin of Yuma Clinical Trials
- [10:07](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-22-038-clinical-trials-with-dan-sfera#t=607) The Problem with ePro Technology and Patient Burden
- [15:41](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-22-038-clinical-trials-with-dan-sfera#t=941) Patient Recruitment, Screening, and High Screen-Failure Rates
- [29:23](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-22-038-clinical-trials-with-dan-sfera#t=1763) Randomization, Investigational Product (IP) Management, and Mix-up Risks
- [38:50](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-22-038-clinical-trials-with-dan-sfera#t=2330) Clinical Trial Phases 1-4 and Patient Incentives
- [45:35](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-22-038-clinical-trials-with-dan-sfera#t=2735) Sponsor vs. CRO Dynamics and FDA Accountability
- [48:27](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-22-038-clinical-trials-with-dan-sfera#t=2907) IRB Roles, Ethics, and Informed Consent Processes
- [59:54](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-22-038-clinical-trials-with-dan-sfera#t=3594) HIPAA, PHI Protection, and Data Analysis
- [1:08:19](https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-22-038-clinical-trials-with-dan-sfera#t=4099) Recruitment Challenges, Completion Rates, and Decentralized Clinical Trials

## Topics

- [Validation & product-market fit](https://hardwarepodcasts.com/topic/validation-and-product-market-fit)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)
- [Security & privacy](https://hardwarepodcasts.com/topic/security-and-privacy)
- [Manufacturing partners & offshoring](https://hardwarepodcasts.com/topic/manufacturing-partners)
- [Medical & health devices](https://hardwarepodcasts.com/topic/medical-devices)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Connected products & IoT](https://hardwarepodcasts.com/topic/connected-products-and-iot)

## Most relevant to

early-stage companies

## Mentioned

- Yuma Clinical Trials (company)
- Comprehensive Guide to Clinical Research (other)
- CRA and CRC Academies (other)
- DSCS Sweat Equity and Investments (company)
- South Coast Clinical Trials (company)
- USC (other)
- Jenny Craig (other)
- FDA (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)
- [#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)
- [Managing Clinical Data Activities](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-07-07-managing-clinical-data-activities) (Global Medical Device Podcast)
- [#362: Managing Risk in Clinical Investigations](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-04-25-362-managing-risk-in-clinical-investigations) (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)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/lets-combinate/2022-06-22-038-clinical-trials-with-dan-sfera. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Let's Combinate.