Innovating Clinical Trials

Ep. 2.25 The Burdens Still Breaking Clinical Trials: 50-Page Consents, Broken Tech, and Stolen CRCs

15 min · 17. juni 2026
episode Ep. 2.25 The Burdens Still Breaking Clinical Trials: 50-Page Consents, Broken Tech, and Stolen CRCs cover

Beskrivelse

In this episode, Ted  opens with a poem that captures the persistent, compounding burden on clinical trial sites: 50-page consents, non-functional tech, poached CRCs, financial holdbacks, and study designs that ask far too much from participants for far too little payoff. What follows is a candid conversation between Ted and Liam about why these problems haven't gone away and in many cases, have gotten worse. Study visits in 2026 take twice as long as a decade ago. One in three procedures collected don't support a primary or key secondary endpoint. Endpoints, procedures, and planned visits have each grown by roughly 40% over 15 years. But this episode isn't only a critique. Conversations with small biotech, mid-size sponsors, and a large pharma groups, all reached out to ask what sites actually need and what's getting in the way. Thirty years ago, that didn't happen. There is a shift and that's worth paying attention to.

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54 episoder

episode Ep. 2.25 The Burdens Still Breaking Clinical Trials: 50-Page Consents, Broken Tech, and Stolen CRCs cover

Ep. 2.25 The Burdens Still Breaking Clinical Trials: 50-Page Consents, Broken Tech, and Stolen CRCs

In this episode, Ted  opens with a poem that captures the persistent, compounding burden on clinical trial sites: 50-page consents, non-functional tech, poached CRCs, financial holdbacks, and study designs that ask far too much from participants for far too little payoff. What follows is a candid conversation between Ted and Liam about why these problems haven't gone away and in many cases, have gotten worse. Study visits in 2026 take twice as long as a decade ago. One in three procedures collected don't support a primary or key secondary endpoint. Endpoints, procedures, and planned visits have each grown by roughly 40% over 15 years. But this episode isn't only a critique. Conversations with small biotech, mid-size sponsors, and a large pharma groups, all reached out to ask what sites actually need and what's getting in the way. Thirty years ago, that didn't happen. There is a shift and that's worth paying attention to.

17. juni 202615 min
episode Ep 2.24 The Decision Threshold Matrix: Why Patient Motivation Isn't Fixed and What It Means for Trial Recruitment cover

Ep 2.24 The Decision Threshold Matrix: Why Patient Motivation Isn't Fixed and What It Means for Trial Recruitment

In this episode, Liam and Ted explore one of the most underexamined problems in clinical trial recruitment: patient motivation is not static.  Drawing on real-world experience from a late-night participant funnel audit to an insomnia study no-show Liam introduces two interconnected frameworks: the Decision Threshold Matrix and the Trial Value Equation. The matrix maps patient motivation across four quadrants defined by disease severity and perceived treatment adequacy. It breaks down how patients unconsciously calculate whether participation is worth it and why trial teams consistently inflate the denominator (burden) without strengthening the numerator (benefit).  Together, these tools offer a behavioral science-grounded lens for understanding when, why, and how patients engage with research and what teams can do about it. This episode is for anyone working in patient recruitment, site management, or protocol design.

10. juni 202621 min
episode Ep 2.23: Jill Fikowski on Why Participants Drop Out and What to Do About It (3/3) cover

Ep 2.23: Jill Fikowski on Why Participants Drop Out and What to Do About It (3/3)

In the final episode of our three-part series with Jill Fikowski, founder and CEO of Changemark Research + Evaluation, we get into one of the most persistent problems in clinical research: retention. Jill unpacks why participants drop out and it's rarely what sponsors assume.  From there, we get into the pressure that lands on research coordinators when enrollment is behind, the practices that pressure produces. We also look at what happens after the last visit particularly in psychedelic trials and whether researchers have a responsibility that doesn't end when the database closes. Retention problems, Jill argues, are almost always inception problems. And solving them starts with a question most teams never ask. Part 3 of 3.

21. maj 202613 min
episode Ep 2.22: Jill Fikowski on Designing Trials That Communities Actually Want to Join (2/3) cover

Ep 2.22: Jill Fikowski on Designing Trials That Communities Actually Want to Join (2/3)

In Part 2 of our conversation with Jill Fikowski, founder and CEO of Changemark Research + Evaluation, we get into what good community engagement actually looks like in practice not as a checkbox, but as a core design principle. Jill opens with a clear answer to what good looks like: involve community from the very beginning and not just at the consent stage, not just in an advisory board email, but in protocol design, recruitment strategy, and how findings are shared. Jill walks us through a Quebec youth cannabis and psychosis study that surpassed both its enrollment and retention targets simply by asking participants what they needed before the protocol was finalised.  We also get into the tension between industry-sponsored research and genuine community care.   Part 2 or 3

20. maj 202621 min
episode Ep 2.21: Jill Fikowski on on Substance Use, Stigma, and the Research That Actually Changed Policy (1/3) cover

Ep 2.21: Jill Fikowski on on Substance Use, Stigma, and the Research That Actually Changed Policy (1/3)

Jill Fikowski, founder and CEO of Changemark Research + Evaluation, brings 25+ years of lived and professional experience in substance use and mental health research. In this episode we cover her work on the SALOME trial, one of the rare studies that directly changed policy. But it wasn't just the science. It was how they centered participants from the beginning. We also explore: 1. How to design community engagement and knowledge translation into your trial from day one 2. The gap between saying participants matter and actually building research around their humanity 3. What happens when you ask participants at the end: "What could we have done better?" 4. The difference between checking the box on community input and genuinely centering stakeholder voices She challenges us to confront how our biases shape every decision: who we enroll, what data we collect, what we do with findings, and whether we ever ask participants what they actually needed.  Part 1 of 3.

19. maj 202613 min