Episode 58 - Interpretation of ICH GCP part 1

In this episode, we’re talking about Site Selection, which means how it is decided which clinical locations should conduct a clinical study. If you haven’t already, before we get into this episode I really recommend you check out Ep 16 (End to end of a study for a rapid paced overview of a study from beginning to end), Ep 21 (Site start up) and Ep 36 (A day in the life of a research site) to get the idea of what we’re talking about in the wider context. Remember, you can get in touch with us via [email protected]. 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/

In this episode, we’re talking about generic medicines. We’re going to outline what they are, how they end up on the market and perhaps in your medicine cabinet and the advantages/ disadvantages of them.  Remember, you can get in touch with us via [email protected]. 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.thebureauinvestigates.com/stories/2025-06-25/what-are-generic-drugs-and-are-they-safe https://www.ummhealth.org/simply-well/the-pros-and-cons-of-using-generic-drugs https://www.moneysavingexpert.com/news/2016/06/revealed-huge-price-differences-between-branded-and-own-brand-medicines-and-generic-equivalents/

It is finally time for another long awaited Q&A episode! Elyse is the questioner and Debbie does her best with the pre-researched and prepared answers. Huge thanks to everyone who submitted a question - don’t hesitate to send any more you may have to our email address!  Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and suggestions into us! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ References -  https://casp-uk.net/casp-tools-checklists/ http://www.understandinghealthresearch.org/# https://sites.google.com/nihr.ac.uk/pi-standards/home https://www.cochranelibrary.com/  https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/humanitarian-device-exemption  https://www.fda.gov/emergency-preparedness-and-response/preparedness-research/animal-rule-information   

In this episode, we’re talking about anti-microbial resistance (AMR). The episode will include what we mean by a pathogen, how they may become resistant, how that resistance spreads and what we can do about it.  Remember, you can get in touch with us via [email protected]. 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.bbc.co.uk/sounds/play/w3ct6sxh  https://www.ncbi.nlm.nih.gov/books/NBK513277/  https://www.who.int/news/item/14-06-2024-who-releases-report-on-state-of-development-of-antibacterials  https://today.uic.edu/new-antibiotic-attacks-bacteria-in-never-before-seen-way/  https://warwick.ac.uk/news/pressreleases/new_antibiotic_for_drug_resistant_bacteria_found_hiding_in_plain_sight/ https://www.who.int/europe/news-room/fact-sheets/item/bacteriophages-and-their-use-in-combating-antimicrobial-resistance  https://www.youtube.com/watch?v=NWo4MwE3zfU  Meera Senthilingam - “Outbreaks & Pandemics”, particularly Chapter 6

It’s time for us to update you on current events, medical research or drugs in the news! We’ve got a few stories at different points in their research journey, from just getting started to failing publicly, and an update on regulation changes in the UK.  Remember, you can get in touch with us via [email protected]. 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.bbc.co.uk/news/articles/c4gllr5y3n2o https://www.theguardian.com/science/2026/may/30/cancer-jab-can-eradicate-entire-tumours-in-patients-trial-shows https://www.theguardian.com/science/2026/may/30/trial-of-multi-cancer-blood-test-among-142000-nhs-patients-fails-to-meet-main-aim https://www.legislation.gov.uk/uksi/2025/538 https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/clinical-trial-regulations-reform/

Episode 60   In this episode, we’re back in Elyse’s corner (hooray!), and today, we’re talking about the interstitium (with a prelude into the human lymphatic system). Don’t worry if you have no clue what either of those things are, we’re doing a basic guide today but check out the references for much more info! Remember, you can get in touch with us via [email protected]. 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.nature.com/articles/s41598-018-23062-6.pdf  https://pmc.ncbi.nlm.nih.gov/articles/PMC6399417/  https://www.scientificamerican.com/article/meet-your-interstitium-a-newfound-organ/ https://www.nytimes.com/interactive/2026/05/11/magazine/interstitium-anatomy-acupuncture-medicine.html

This is part 2 of our discussion on interpretation of GCP. If you haven’t listened to part 1, I recommend going and checking that out first. We’re covering a few more examples where ICH GCP sets out the principles and practices that should be followed to have harmonised, quality research.  Remember, you can get in touch with us via [email protected]. 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/

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 [email protected]. 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/

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 [email protected]. 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

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 [email protected]. 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