Intro to Clinical Research

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

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 [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/

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 [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/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