Clinical Trial Files

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

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

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• 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.

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• File #005: Punk Rock and Patient Hope: Patryk Mikucki 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 innovationBuilding empowered, passionate global teamsDiversity beyond race: disability, access, and health equity in clinical trialsThe power of real-world evidence and personalized medicineHis dream of customized, on-demand clinical trials powered by 3D printingWith 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.”

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

  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

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