The Tea in STEM

<p>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...

<p>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...

<p>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...

<p> 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...

<p>Part 1: Regulatory</p><p> 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...

<p>E<b>pisode 7: Big Pharma… in a Kitchen?!</b> 🍳💊🚔</p><p>What happens when a man decides to <b>skip the lab, the regulations, and basic ethics</b>—and mass-produce <b>fake medication</b> in his own...

<p> 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...

<p>Last time, we uncovered the shocking moment when a doctor running shady clinical trials told the <b>FDA</b>:<br/> “This isn’t your jurisdiction.” </p><p>Well… the FDA <b>disagreed.</b></p><p>Now, in Part 2, we’re...

<p>What happens when you tell the FDA "Monitoring my clinical trials is not your jurisdiction". The FDA is known for many things, but in the world of clinical trials, we know that if you F*** around, the FDA will find...

<p> 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...

<p>Brittney is back with the Tea in STEM to discuss what she wished she knew as a new coordinator. <br/>Some common issues or struggles, and some ways to overcome them.</p>

<p>The FDA is known for many things, but in the world of clinical trials, we know that if you F*** around, the FDA will find out. <br/><br/>Episode 5 of Wild FDA audit stories. </p>

<p> 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...

<p> 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...

<p> 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...