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Anna Fehr And Alexandria Clark Podcasts

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When 26-year-old Markinson suffered a psychotic break, he was given a choice no one should ever face: participate in a clinical trial or face long-term involuntary confinement. What followed was a tragic chain of events—his worsening condition, the helpless fight of a mother trying to save her son, and ultimately, a suicide that would spark a natio…
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In this chilling episode of Dark History of Clinical Trials, we explore the devastating 2016 Phase 1 clinical trial in Rennes, France, that left one man dead and several others with lasting neurological damage. Designed to test a new painkiller, the study went catastrophically wrong after investigators escalated the dose without properly analyzing …
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In Part 3 of our series on government-funded clinical trials, we shift the focus to the upsides of working in publicly funded research. From greater patient diversity and broader public health impact to mission-driven work and long-term study follow-through, we highlight what makes this space both rewarding and unique. We also explore what kind of …
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In this continuation of our deep dive into government-funded clinical trials, we explore real-world examples of how these studies operate differently from private pharma-sponsored research. Our guest shares firsthand insights into challenges like proving adverse events without medical records, navigating patient compensation differences, and the di…
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Part 1: Regulatory In this episode, we sit down with a clinical research coordinator from a government-funded hospital to explore the unique challenges and regulatory differences between publicly funded and private pharmaceutical company-sponsored trials. We discuss key topics such as study selection, start-up timelines, and the distinct approval p…
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Episode 7: Big Pharma… in a Kitchen?! 🍳💊🚔 What happens when a man decides to skip the lab, the regulations, and basic ethics—and mass-produce fake medication in his own kitchen? The FDA found out. And let’s just say… he fked around and definitely found out. In this episode, we unravel the insane true story of a DIY “pharmaceutical empire,” the dang…
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Not all medical disasters stem from unethical research—sometimes, even the most promising trials take a devastating turn. In this episode, we examine a clinical trial that had a flawless safety profile in pre-clinical testing but went horribly wrong when tested in humans. What critical mistakes were made? How did the researchers miss the warning si…
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In this episode, we uncover the shocking and often tragic history of clinical trials gone wrong. These cases exposed the dire need for ethical oversight in medical research. But from these dark moments came progress: the Belmont Report, informed consent, and strict regulations that protect patients today. Join us as we explore how past mistakes sha…
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In this episode of Tea in STEM, we're joined by Nikki Jundt, a seasoned regulatory specialist, to delve into the complexities of Investigator Site File (ISF) maintenance. Nikki shares her expertise and highlights critical challenges faced by research sites, drawing from her recent experience on a CDISC conference panel alongside FDA auditors and CR…
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In Part 2 of our discussion on the FDA’s new guidance for clinical trials, we move from theory to practice. Ted B. from Medvector joins us again to dive into solutions for addressing potential challenges when implementing this new flexibility allowing healthcare providers (HCPs) to conduct visits with Principal Investigator (PI) oversight.…
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In this episode, we dive into the latest FDA guidance expanding flexibility for clinical trials by allowing healthcare providers (HCPs) to conduct visits under Principal Investigator (PI) oversight. What does this mean for patients, research sites, and sponsors? Join us as we sit down with Ted Barduson, COO and Co-founder of Medvector to discuss th…
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