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Intro to Clinical Research: Daily Summaries Delivered
by Debbie and Elyse
Welcome to the Introduction to Clinical Research Podcast! Join Debbie, a clinical research professional, as she explains clinical research to her friend Elyse. Curious how the COVID vaccine was developed so quickly? Ever wondered what rules determine when you can get a new drug? Remember that one miracle drug they swore would cure cancer back in 2002 but then you never heard of it again? Let’s talk about that.
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- 1 weeks ago51 min
Episode 58 - Interpretation of ICH GCP part 1
Today, we’re finally getting into why Debbie says “it depends” so much in answer to many of Elyse’s questions. We’re looking at how ICH GCP sets out the principles and practices that should be followed to have harmonised, quality research. This is part 1, so stay tuned for part 2 following soon! Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
- May 4, 202650 min
Episode 57 - Medical Ethics
Today, Debbie throws us all back into the Philosophy Ravine together to discuss medical ethics. We’re going to talk about what it is and use the framework of Medical Ethics to consider two case studies - the Minnesota Starvation Experiments and Covid-19 Challenge Studies. Content Warning - this podcast does discuss WW2, and experiments where patients chose to restrict their access to food. Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ References - https://www.bmj.com/content/371/bmj.m4258#:~:text=In%20the%20current%20pandemic%2C%20over%2038%20000,a%20non%2Dprofit%20organisation%20advocating%20for%20these%20volunteers https://www.bbc.co.uk/news/health-56097088#:~:text=Getty%20Images,more%20than%2015%20million%20people. https://www.pushkin.fm/podcasts/revisionist-history/the-rise-of-the-guinea-pigs https://thispodcastwillkillyou.com/2025/10/14/episode-190-starvation-more-than-hunger/ Firsthand: The Minnesota semi-starvation experiment, University Publications, Archives & Special Collections, Colorado State University https://hdl.handle.net/10217/02.0036381
- Apr 13, 202651 min
Episode 56 - International Collaboration
In this episode, we’re going to be discussing some international collaborations in clinical research! Let’s cross some borders and work together! Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ References - https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/opening-procedures-ema-non-eu-authorities-open-framework Who Guidance for Best Practice on Clinical Trials - https://iris.who.int/server/api/core/bitstreams/dbe6d97c-b659-4e7b-8070-b4a3c667d6e5/content https://picscheme.org/en/about
- Mar 30, 202654 min
Episode 55 - Safety Events & Investigator's Brochure
Hey everyone! We’re back (again!) and we hope you didn’t miss us too much. In this episode, we’re going to be discussing safety events, safety reporting and the compilation of information in the Investigator’s Brochure. Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
- Dec 22, 202548 min
Episode 54 - Medical Devices
Hey everyone! We’re back and we hope you didn’t miss us too much. In this episode, we’re diving right back in and talking about Medical Devices - what they are, how varied they can be, and how they’re regulated (in general terms!) Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ References https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices https://www.fda.gov/medical-devices/regulatory-controls/general-controls-medical-devices https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/class-ii-special-controls-documents https://www.fda.gov/media/82395/download https://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirements https://hollandhoudek.com/implants
- Oct 6, 202557 min
Episode 53 - Elyse's Corner: Anthrax Vaccines
In this episode, we’re back in Elyse’s corner (hooray!), and today, we’re talking about Anthrax, and Anthrax vaccines. Maybe you know as little about it as Debbie, or maybe you know loads, but as always, Elyse is going to guide us through this topic from her goblin corner! Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ References https://www.ncbi.nlm.nih.gov/books/NBK220522/ https://www.cdc.gov/anthrax/prevention/index.html https://blogs.cdc.gov/niosh-science-blog/2022/04/21/welders-anthrax/ https://www.cnn.com/2024/05/05/us/how-it-really-happened-anthrax-attacks https://pmc.ncbi.nlm.nih.gov/articles/PMC7993152/ https://journalofethics.ama-assn.org/article/informed-consent-military-anthrax-vaccination-case/2007-10 https://www.fbi.gov/history/famous-cases/amerithrax-or-anthrax-investigation https://www.sciencedirect.com/science/article/abs/pii/S0264410X22010453 https://pmc.ncbi.nlm.nih.gov/articles/PMC6147967/ https://ajph.aphapublications.org/doi/full/10.2105/AJPH.92.5.715 https://clearinghouse.net/doc/40458/ https://web.archive.org/web/20171114165441/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474027.htm https://web.archive.org/web/20171114200815/https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMRegulatoryScience/ucm391665.htm https://www.fda.gov/vaccines-blood-biologics/vaccines/biothrax
- Sep 22, 20251h 0m
Episode 52 - Data Management
In this episode, we’re talking about Data Management because of a listener question - thanks very much Aswini! So, we get into the weeds about the data that is collected as part of a clinical trial and what is done with it - including what “data cleaning” really is! Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/
- Sep 8, 202551 min
Episode 51 - Good Manufacturing Practice (GMP)
Today, we’re going to discuss Good Manufacturing Practice - GMP - which is like GCP but for the manufacturing of drugs, devices, food and cosmetics rather than the clinical processes involved in research. Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ References - https://database.ich.org/sites/default/files/Q7%20Guideline.pdf https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice https://pmc.ncbi.nlm.nih.gov/articles/PMC7395820/ Maintenance Phase Episode - https://open.spotify.com/episode/2iqRW5kzS02w4HRi6vOi6Q
About Intro to Clinical Research
Welcome to the Introduction to Clinical Research Podcast! Join Debbie, a clinical research professional, as she explains clinical research to her friend Elyse. Curious how the COVID vaccine was developed so quickly? Ever wondered what rules determine when you can get a new drug? Remember that one miracle drug they swore would cure cancer back in 2002 but then you never heard of it again? Let’s talk about that.
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