Hardware Podcasts

038 - "Clinical Trials" with Dan Sfera

Let's Combinate · 22 Jun 2022 · 1h 13m

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Yuma Clinical Trials, DSCS Sweat Equity and Investments, South Coast Clinical Trials
Also
Comprehensive Guide to Clinical Research, CRA and CRC Academies, USC, Jenny Craig, FDA

Related episodes from other shows

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 54m

    #338: Site Selection for Clinical Trials

    Isabella Schmidt and Samantha Pickett from Proxima Clinical Research discuss the critical process of selecting clinical trial sites for medical devices. They emphasize starting with a complete protocol to guide feasibility questionnaires and site qualification visits, highlighting the importance of patient diversity, investigator bandwidth, and technological readiness. The experts warn against defaulting to Key Opinion Leaders (KOLs) without verifying their capacity and advise using central IRBs to accelerate startup timelines while ensuring diverse patient enrollment.

    Validation & product-market fitQuality & yield
    7 chapters

  • Global Medical Device Podcast · 30m

    #419: Essential Strategies for CRO Success in Today's Clinical Landscape

    Christine Wilbert, an account executive at Greenlight Guru, discusses strategic considerations for Clinical Research Organizations (CROs) selecting Electronic Data Capture (EDC) systems. She emphasizes the critical need for due diligence, scalability from pilot to pivotal studies, and robust post-sales support to avoid hidden costs. The conversation highlights the importance of intuitive design, speed of implementation, and involving site users to ensure data integrity and adoption in medical device trials.

    Validation & product-market fitConnected products & IoT
    8 chapters

  • Global Medical Device Podcast · 24m

    Managing Clinical Data Activities

    Pall Johannesson, CEO and co-founder of Smart Trial, explains how his digital platform helps medical device companies manage clinical data activities, addressing the industry's historical reliance on outdated paper and Excel-based systems. He discusses the impact of EU MDR and the pandemic on clinical trial strategies, noting a shift toward decentralized or hybrid trials and the importance of collecting clinical evidence early to avoid regulatory delays. Johannesson highlights common mistakes, such as collecting too much data without statistical rigor, and emphasizes best practices like involving statisticians early and planning for post-market surveillance from the start.

    Medical & health devicesValidation & product-market fit
    8 chapters

  • Global Medical Device Podcast · 39m

    #362: Managing Risk in Clinical Investigations

    Helene Quie, a medical device regulatory expert, explains the dual nature of risk management in clinical investigations, distinguishing between residual product safety risks and procedural risks inherent in study protocols. She emphasizes the need for measurable, data-driven benefit-risk assessments to satisfy ethics committees and competent authorities, particularly under the EU MDR. Quie highlights the operational challenges of enrolling vulnerable patient populations, such as children or acute patients, and the regulatory confusion surrounding the integration of AI in medical devices.

    Medical & health devicesCertification & compliance
    6 chapters

  • Global Medical Device Podcast · 49m

    #373: Creative Clinical Recruitment

    Dr. Kelly Palmer, an Assistant Professor at the University of Arizona and former Principal Investigator at IU School of Medicine, discusses innovative strategies for recruiting diverse populations into clinical trials. She details how moving from traditional mailings to 'guerrilla marketing' and community partnerships with churches and local organizations significantly improved recruitment ROI and trust. Palmer also explains the operational shift from paper-based data collection to electronic data capture (EDC) on iPads to reduce errors and increase efficiency, while emphasizing the need for flexibility in handling logistical barriers like childcare and transportation for participants.

    Validation & product-market fitScaling production
    8 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Let's Combinate. The episode itself belongs to its publisher.