Clinical Trial Files

About Clinical Trial Files

Karin Avila, Roberto Torres, and Taymeyah Al-Toubah welcome you to Clinical Trial Files — your window into the world of clinical research beyond the protocol. 🎙️📁 We’re excited to open the files on the people, processes, and progress shaping today’s global research landscape. With over 40 years of combined experience in clinical research—and more than 15 roles spanning research coordination to executive leadership, from hands-on clinical investigations to operations oversight—we bring a wide-lens view of this dynamic field. Together, we’ve supported, managed, or influenced over 800 clinical trials across 45 countries and six continents. Our global perspective is rooted in real-world connections and cross-cultural collaboration. In this podcast, we’ll: 🔍 Share behind-the-scenes insights from every corner of the research ecosystem 🎤 Host thoughtful conversations with diverse voices in the industry 🌐 Highlight global perspectives on trends, challenges, and opportunities From career development and training to emerging technologies like AI, Clinical Trial Files explores the issues shaping research today—and tomorrow. Whether you're navigating your first trial or leading your fiftieth, our goal is to inform, connect, and inspire. 🎧 Join us as we break down clinical research—one file at a time.

Publisher

Clinical Trial Files

Category

education · health & fitness

Language

en

Explicit

No

First episode

8 May 2025

Latest episode

17 May 2026

Latest episodes

10 episodes in the feed.

1. 

   17 May 2026

   File #010: Fixing the Evidence Engine: Shaun Treweek on Trial Design, Recruitment, and Doing Research Better

   Clinical trials are the backbone of evidence-based medicine—but too often, they struggle with inefficiency, poor recruitment, and avoidable design flaws. In this episode of Clinical Trial Files, we’re joined by Shaun Treweek, Professor of Health Services Research and a leading voice in clinical trial methodology. Shaun shares his perspective on why so many trials fail to recruit as planned, what the research community gets wrong about trial design, and how embedded studies and methodological research can dramatically improve how trials are run. Drawing from decades of experience across academia, global research collaborations, and methodological innovation, he challenges conventional thinking and advocates for a more evidence-informed approach to doing research itself. We explore practical ways to make trials more efficient, more ethical, and more likely to deliver meaningful results—while asking a fundamental question: Why don’t we apply the same rigor to how we design trials as we do to the interventions we test? Whether you’re a researcher, coordinator, sponsor, or policymaker, this episode offers a thoughtful, grounded look at how we can stop repeating the same mistakes and start building better trials from the ground up.

2. 

   16 May 2026

   File #009: Building Quality Into Clinical Trials: A Data-Driven Mindset from Day One with Akanksha Jain

   In this episode of Clinical Trial Files, we’re joined by Akanksha Jain, a clinical research quality and data professional with deep expertise spanning biostatistics, data management, risk-based quality management (RBQM), and trial oversight. Akanksha shares her career journey from a strong foundation in statistics into clinical research, offering a unique perspective on how data, quality, and operational decision-making intersect across the clinical trial lifecycle. She explains why quality cannot be an afterthought—and how embedding risk-based thinking early in study design leads to stronger outcomes, better compliance, and fewer downstream issues. The conversation explores practical applications of RBQM, centralized monitoring, and data-driven oversight, along with common misconceptions about quality roles in clinical trials. Akanksha also discusses the evolving expectations under ICH E6 (R3), including proactive risk identification, cross-functional collaboration, and the growing importance of analytics in sponsor and CRO decision-making. Listeners will gain insight into how quality professionals can move from reactive issue management to strategic partners within clinical development teams—and how early-career professionals can build the skills needed to thrive in an increasingly data-centric research environment. This episode is a must-listen for clinical research professionals interested in quality management, data strategy, monitoring innovation, and the future of risk-based oversight.

3. 

   8 Feb 2026

   File #008: Breaking Silos in Clinical Research: Karen Cloete on Training the Whole Trial Ecosystem

   In this episode of Clinical Trial Files, we sit down with Karen Cloete, founder of TASK Research Academy, to explore how clinical research training can, and must, evolve beyond silos and checklists. With over 17 years of experience across clinical operations, monitoring, audits, compliance, and sponsor oversight, Karen shares her unconventional journey into clinical trials and how seeing the industry from every angle inspired her to rethink how professionals are trained. From CRA to site leader to sponsor-side expert, Karen explains why understanding the entire clinical trial lifecycle is essential for quality, compliance, and career growth. The conversation dives into real-world challenges in global training, including language barriers, cultural context, and regulatory complexity, and how animation, simulation, and scenario-based learning can make training more inclusive, practical, and engaging. Karen also discusses TASK Research Academy’s innovative approach to experiential learning, internships, and workforce development, helping research-naïve professionals successfully enter the field. We also unpack key updates from ICH E6 (R3), including service provider oversight, data governance, sponsor responsibilities, and decentralized trial considerations—what they mean in practice and where sites should focus now. Whether you’re a CRA, coordinator, investigator, sponsor, or educator, this episode highlights why seeing the “big picture” in clinical research isn’t optional—it’s foundational.

4. 

   13 Aug 2025

   File #007: Empathy & Equity: Redefining Clinical Trials with Patient Voices"

   In this compelling episode of Clinical Trial Files, hosts Karin Avila and Taymeyah Al‑Toubah sit down with Dr. Hillary Edwards from the University of Maryland’s Patients Program. They explore the evolution of patient‑centered and ethical clinical research—from historical wrongs like the Nuremberg Trials and Tuskegee to modern movements such as the formation of PCORI and the impact of COVID‑19 in increasing public trust and trial accessibility. Dr. Edwards shares how the Patients Professors Academy fosters shared governance, continuous patient engagement, and a common research language to better enroll, retain, and serve participants. Through vivid metaphors (like comparing radiation therapy to spray versus stream) and personal anecdotes—from dentist relationships to international travel—she illustrates how empathy, clarity, and inclusivity transform clinical trials into trustworthy, equitable, and human-centered endeavors.

5. 

   23 Jul 2025

   File #006: Hope in Every Trial: Dr. Jaydira Del Rivero on Rare Cancers, Clinical Models, and the Power of Patient Advocacy

   In this inspiring episode of Clinical Trial Files, Dr. Jaydira Del Rivero, triple-board-certified oncologist and endocrinologist at the NIH, shares her deeply personal journey from internal medicine to leading global research on rare endocrine cancers. Joined by hosts Taymeyah Al-Toubah, Karin Avila, and Roberto Torres, Dr. Del Rivero reflects on overcoming early career setbacks, the value of mentorship, and the importance of lifelong learning. She breaks down complex concepts like natural history studies, explains the challenges of designing trials for ultra-rare tumors like pheochromocytomas and ACC, and makes a compelling case for personalized medicine, improved community education, and quality-of-life endpoints in research. Her compassion, humility, and patient-driven mission offer rare insights into the human side of science.

6. 

   9 Jul 2025

   File #005: Punk Rock and Patient Hope: Patryk Micucki on Humanizing Clinical Trial

   In this inspiring episode, we sit down with Patryk Mikucki, Vice President and Global Head of Country Operations at Alexion AstraZeneca Rare Diseases. With over 25 years of experience across veterinary medicine, academia, and the pharmaceutical industry, Patryk brings a bold, deeply human perspective to the world of clinical trials. From his unexpected career journey—starting with animal ethics committees in Poland to building operations in Ukraine—to his philosophy of punk-rock leadership, Patryk emphasizes diversity, transparency, emotional intelligence, and hope as essential elements in research. We discuss: The future of AI in pharma and patient-centric innovation Building empowered, passionate global teams Diversity beyond race: disability, access, and health equity in clinical trials The power of real-world evidence and personalized medicine His dream of customized, on-demand clinical trials powered by 3D printing With heart, humor, and fierce honesty, Patryk shares what it really takes to move science forward—without losing sight of the people it’s meant to serve. 💬 “As long as we don’t have solutions for all patients, we are not done.”

7. 

   25 Jun 2025

   File #004: Paramedics, Pipelines & Phase 4: Doug Schantz on Steering Global Clinical Ops

   Doug Schantz shares how his paramedic background informs his leadership in global clinical operations across various therapeutic areas, offering insights into managing international studies and building strong site relationships in this interview.

8. 

   12 Jun 2025

   File #003: From Fast Data to Faster Drugs — Thomas Wood on AI for Clinical Trials

   NLP expert Thomas Wood discusses with hosts Karin and Taymeyah how artificial intelligence accelerates clinical trials, highlighting his work with Fast Data Science and the Clinical Trial Risk Tool in this interview.

9. 

   20 May 2025

   File #002: At the Heart of Clinical Research Nursing

   Join us as seasoned Clinical Research Nurse (CRN) Elyce takes us inside the intersection of science, ethics, and compassionate patient care. Tracing the CRN role’s evolution—from navigating rigid study protocols to championing patient-centered advocacy—Elyce reveals the ethical tightropes nurses walk, the trust they build, and the values that guide them. She shares personal stories, career advice, and points listeners to resources like the International Association of Clinical Research Nurses (IACRN) that are shaping the profession’s future. Whether you’re curious about clinical trials or considering a career in research nursing, this candid conversation offers an inspiring, insider’s guide to the vital work of CRNs.

10. 

    8 May 2025

    File #001: Meet the Cohosts

    Clinical trials affect millions—but most people have no idea how they actually work. In our pilot episode, meet your cohosts Roberto Torres, Taymeyah Al-Toubah, and Karin Avila as they share their personal paths into research and why this field matters more than ever. From the human impact of oncology trials to how natural disasters can disrupt research, this episode dives into the real challenges, surprising stories, and the power of collaboration in clinical science. Whether you’re a curious outsider or deep in the research world, this series will help you see trials in a whole new way.

Reach and audience

Public platform figures. Ratings count people who left a rating, not total listeners.

Apple Podcasts (US)

3.0 / 5

2 ratings

Podcast Authority Score: 19 / 100

A composite of feed quality, social presence, YouTube performance and engagement. Read the methodology.

Quality

25

Social presence

0

YouTube

0

Engagement

30

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Based on episode analysis; this does not confirm that the show is currently accepting guests.