Shows
The Tea in STEMDark History of Clinical Trials Part 5In this powerful installment of Dark History of Clinical Trials, we examine one of the most tragic and transformative episodes in pharmaceutical history: the thalidomide disaster.Marketed as a safe sedative and morning sickness treatment in the late 1950s, thalidomide was distributed to thousands—only to cause severe congenital deformities and pregnancy losses across the globe. This catastrophe exposed critical flaws in drug testing, marketing, and approval processes.In this episode, we uncover:The rise and reckless distribution of thalidomideThe real human cost behind corporate and regulatory failuresHow this tragedy reshaped modern drug approval la...2025-06-3009 minThe Tea in STEMFDA: F*** Around and Find out Episode 8In this episode, we dive deep into the recent FDA action that exposed a pharmaceutical manufacturer distributing counterfeit codeine cough syrup. What began as a quiet compliance concern quickly escalated into a full-scale investigation—leading to shutdowns, criminal charges, and regulatory fallout.2025-06-1016 minThe Tea in STEMDark History of Clinical Trials Episode 4When 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 national conversation about ethics, consent, and mental illness in clinical research.In this episode, we examine the heartbreaking story of the Markinson case—a chilling example of how regulatory systems meant to protect can fail the most vulnerable. We explore IRB b...2025-05-2718 minThe Tea in STEMDark History of Clinical Trials Episode 3In 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 earlier data. We uncover what went wrong, the oversight failures, and how it shook public trust in drug development.This tragedy serves as a sobering reminder of why data review, transparency, and ethical safeguards in early-phase trials are not just protocols—they are matters of life an...2025-05-1221 minThe Tea in STEMInterview: Navigating Clinical Trials in Government-Funded Hospitals (Part 3)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 professionals thrive in this environment. Is it the detail-oriented? The mission-focused? The ones who care deeply about equity in access to care?Tune in as we explore why some coordinators and investigators choose this path—and why they stay.2025-04-2114 minThe Tea in STEMInterview: Navigating Clinical Trials in Government-Funded Hospitals (Part 2) 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 disconnect between research benchmarks and real-life feasibility. We also discuss the impact of wealth distribution on patient access and trial participation. What happens when hospitals close patient accounts, but research teams still need documentation? How do these trials ensure continuity of care? Join us as we unpack the complexities of conducting research in a g...2025-04-0718 minThe Tea in STEMInterview: Navigating Clinical Trials in Government-Funded Hospitals Part 1Part 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 processes that shape the landscape of government-backed research. How do these differences impact trial efficiency, patient access, and innovation? Tune in for an insider’s perspective on the critical nuances of conducting research outside the private sector. Stay tuned for Part 2. 2025-04-0113 minThe Tea in STEMFDA: F*** Around and Find Out Episode 7Episode 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 dangerous fake drugs that hit the market, and how it all ended with a one-way ticket to prison....2025-03-2415 minThe Tea in STEMDark History of Clinical Trials Episode 2 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 signs? 2025-03-1715 minThe Tea in STEMFDA: F*** Around and Find Out Episode 6 part 2Last time, we uncovered the shocking moment when a doctor running shady clinical trials told the FDA: “This isn’t your jurisdiction.” Well… the FDA disagreed.Now, in Part 2, we’re looking at what happened next. What punishments did he face? Where is he now? And did justice really get served?2025-03-0323 minThe Tea in STEMFDA: F*** around and Find out Episode 6 part 1What 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 out. Episode 6 part 1 of Wild FDA audit stories. 2025-02-2417 minThe Tea in STEMClinical Trials_Dark History Episode 1 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 shaped the ethical frameworks that safeguard clinical trial participants now. 2025-02-0315 minThe Tea in STEMInterview with a CRC: What I wish I knewBrittney is back with the Tea in STEM to discuss what she wished she knew as a new coordinator. Some common issues or struggles, and some ways to overcome them.2025-01-2818 min
MedEvidence! Truth Behind the Data🎙 Starting a Clinical Research Site After COVID-19 Ep 267Send us a textDr. Michael Koren sits down with Alexandria Clark and Anna Fehr of One of a Kind (1-OAK) Clinical Research to discuss their bold decision to launch a clinical research company in 2021, shortly after the disruptions caused by the COVID-19 pandemic. Dr. Koren reflects on how the pandemic reshaped the clinical research landscape, forcing the closure of many smaller sites which couldn't continue seeing patients in-person. Alexandria and Anna saw an opportunity in the vacuum to build a business specializing in high-need areas like asthma, immunology, and gastroenterology. The conversation also explores the unique...2025-01-1515 minThe Tea in STEMFDA: F*** Around and Find Out Episode 5The 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. Episode 5 of Wild FDA audit stories. 2025-01-1324 minThe Tea in STEMInterview with a Regulatory Specialist: CDISC follow up 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 CRO representatives. This episode discusses DOA regulations, Re-consenting issues, SUSAR management and Central document distribution. Tune in to uncover how to navigate the evolving regulatory landscape with confidence! 2025-01-0619 minThe Tea in STEMFDA Decentralized Guidance with Ted Barduson PART 2 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. 2024-12-2313 minThe Tea in STEMFDA Decentralized Guidance with Ted Barduson PART 1 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 the practical implications of this groundbreaking change. From improving patient access and engagement to navigating oversight and compliance, we explore how this new guidance can reshape the clinical trial landscape. Tune in for insights and actionable tips to put this into practice at your site. 2024-12-1617 minThe Tea in STEMInterview with a CRC: What I wish I knewBrittney joins us again for another episode of Interview with a CRC. Today we discuss some of the common problems and issues facing new CRC's and lessons we wish we learned earlier on in our careers. 2024-05-2716 minThe Tea in STEMInterview with a CRA: Part 2Welcome back to Daniel, an accomplished CRA, as he tells us some of his horror site stories! Bonus: Daniel discusses his side gig.The CRA Coach - CRA Training, Clinical Research Associate Training2024-05-2028 minThe Tea in STEMInterview with a CRA: Part 1Join us as we interview Daniel, a CRA with an impressive career. Anna and Daniel discuss trials and tribulations of the CRA role and the training program Daniel has created to help support CRA's. The CRA Coach - CRA Training, Clinical Research Associate Training 2024-05-1315 minThe Tea in STEMThe Golden Nose: Bad Boy of AstrologyNot all Scientists match the image of a nerdy, pocket protector wearing, loner, in fact, sometimes they are the ones throwing the biggest parties.2024-05-0611 minThe Tea in STEMHappy Accidents: ED treatmentThe Happy Accident of how both the understanding and treatment for ED changed. 2024-04-1510 minThe Tea in STEMCRA Stories: Spilling the TeaJoin us as we share some stories written in about CRA's that were not so ethical in their practices. 2024-04-0823 minThe Tea in STEMThe Father of GastroenterologyToday we discuss the story of the father of Gastroenterology and his early experiments. TW: Graphic wounds verbally described 2024-04-0115 minThe Tea in STEMInterview With a Research Coordinator P2: Sponsor, PI, Patient IssuesBrittney Joins us again to discuss some of the hardships of the CRC role. We talk about sponsor/CRC communication, PI involvement, and some of the struggles in recruitment. 2024-03-2622 minThe Tea in STEMFDA Audits: Manufacturing vs ResearchEver wonder what happens to devices/IP after it leaves the site? Join us as we discuss FDA Audits with J, who has experience with FDA audits in medical device manufacturing, and how these differ from pre-approval research audits. 2024-03-1115 minThe Tea in STEMTo the Discovery of the UndiscoverableBigfoot- the Myth and Legend and the Scientist who gave up his social standing to try to prove its existence. 2024-03-0413 minThe Tea in STEMCRA: F*** around and Find outCRA Horror stories, Catching the bag guy before the FDA does. This Coordinator was caught by their CRA enrolling an ineligible patient as a birthday gift to their boss. 2024-02-2617 minThe Tea in STEMInterview: Women in STEMMajority of STEM fields are male dominated, but how close is social media to real life of a new woman entering the STEM field. Join us for Interviewing Carmen, a Project Manager in Construction. 2024-02-1914 minThe Tea in STEMDinosaur Hunters: The friendship falloutFriendship between scientists that lead to one of the biggest fall-outs in history and also some of the biggest discoveries. 2024-01-2216 minThe Tea in STEMFDA: F*** Around and Find Out Episode 3Physicians taking on too much, when it rains it pours, how to handle a divorce and FDA audit at the same time. 2024-01-1522 minThe Tea in STEMInterview With a Research CoordinatorJoin us for our first interview with a Clinical Research Coordinator. On this episode we discuss Sponsor/Pharma involvement and communication with the site and the inclusivity of technology for patients with diverse backgrounds. 2024-01-0817 minThe Tea in STEMHappy Accidents P52023-12-1114 minThe Tea in STEMDr. Pare- The invention of surgeryDr. Pare the doctor of surgery brought attention to the field and supported new techniques2023-12-0416 minThe Tea in STEMFDA: F*** Around and Find Out Episode 2Unconsented patients, staff untrained... when is busy too much?2023-11-2825 minThe Tea in STEMZombie AntsFollow the discovery of amazing world of parasites2023-11-1308 minThe Tea in STEMFDA: F*** Around and Find OutIf there is one thing we know for sure, that is when it comes to the FDA, if you f*** around they will find out2023-11-0625 minThe Tea in STEMWho Really Invented the TelephoneFind out who actually invented the telephone... 2023-10-3018 minThe Tea in STEMHappy Accident P4Explore the happy accidents that have led to amazing discovery!2023-10-2312 minThe Tea in STEMRevival of the Tasmanian TigerJurassic park showed the dangers of bringing back the dinosaurs, but what if this concept was used for a more recently extinct species. 2023-10-1612 minThe Tea in STEMHappy Accidents P3Explore the Happy Accidents that have led to some of the most amazing scientific advancements! 2023-10-1211 minThe Tea in STEMScientist Mafia31 Scientists in Mexico are being charged with organized crime?!2023-10-0223 minThe Tea in STEMHappy Accidents P2Have you ever wondered how a mishap in the lab has led to some of science's greatest discoveries?2023-09-2513 minThe Tea in STEMTaking Advantage of Vunerable PopulationsWhat happens when vunerable populations are not protected?2023-09-1818 minThe Tea in STEMHappy Accidents P1Have you ever wondered how a mishap in the lab was the reason for some of our biggest scientific breakthroughs? 2023-09-1111 minThe Tea in STEMIntro to usIntroduction to the voices behind the stories, why we started this podcast!2023-09-0304 minThe Tea in STEMScientists, Giants, and GraverobbersUncover the story of how a surgeon got ahold of his most prized possession... ... a giant. 2023-09-0323 min