Clinical Trial Files

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.

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.

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.

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— illustrates how empathy, clarity, and inclusivity transform clinical trials into trustworthy, equitable, and human-centered endeavors.

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— illustrates how empathy, clarity, and inclusivity transform clinical trials into trustworthy, equitable, and human-centered endeavors.

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.

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.”

Veteran clinical-operations leader Doug Schantz joins Clinical Trial Files to trace a career that spans emergency-room stretchers and first-in-human gene-therapy trials. In this lively conversation Doug unpacks:

• how a paramedic’s mindset shaped his approach to Phase 1-4 global programs at Pfizer, AstraZeneca, Alexion, and AskBio;
• the biggest headaches—and hidden advantages—of running studies across borders and therapy areas (oncology, neuroscience, cardiovascular, rare disease, gene therapy);
• practical lessons on in-house vs. outsourced monitoring, risk-based quality management, and building site relationships that last;
• the future of gene-therapy trials—and the three traits he’d engineer into a “perfect” clinical site;

Whether you’re running your first study or steering an entire portfolio, Doug’s candor and hard-won playbook will leave you with fresh tactics—and a few laughs—to bring back to your own trials.

👉 Subscribe for new episodes every 2nd and 4th Wednesday, and share your thoughts with #ClinicalTrialFiles on LinkedIn

Physicist-turned-NLP expert Thomas Wood joins hosts Karin and Taymeyah to explore how artificial intelligence is shortening the road from protocol to patient. Thomas recounts founding Fast Data Science, explains why a Bill & Melinda Gates Foundation grant sparked his open-source Clinical Trial Risk Tool, and reveals the AI workflows already cutting months—and millions—from large pharma studies. The panel marks Alan Turing’s 113th birthday, trades “one thing I wish AI could do today,” and tackles myths around machine learning in healthcare. Looking ahead five-to-ten years, Thomas sketches a future of decentralised, patient-centric trials, but warns of regulatory and data-governance hurdles that still loom. New to the field? Stick around for book picks, career tips and a closing thought experiment for Turing himself.

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.