Intro to Clinical Research

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 

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 
 

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/

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 

Episode 50 - Out-takes and unreleased stuff

Wow, 50 episodes of our podcast. How exciting. So, in celebration, I’ve collected together some out-takes and previously un-released material (un-released, in that, we recorded it and I edited it out of the main episode, often for a good reason!) So you have a real mixed bag selection of Debbie stumbling over words, lots of laughter, reading emails out loud to Elyse, and us talking about how to survive the Skull Cave in Stardew Valley, plus so much more. 
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/

Episode 49 - Patient Reported Outcomes

Today, we’re discussing patient reported outcomes - what are they, how can they be measured and how do they compare to other measures we often use to measure the success (or not) of 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://www.jmir.org/2020/3/e12689/ 
https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-18#:~:text=A%20patient%2Dreported%20outcome%20(PRO,(Powers%20et%20al%202017). 
https://www.gov.uk/guidance/patient-reported-outcomes-and-experiences-study#:~:text=Broadly%2C%20PROMs%20evaluate%20either%20the,pain%20or%20discomfort
https://www.birmingham.ac.uk/research/centres-institutes/patient-reported-outcomes/prolearn/pros-in-trials#:~:text=Capturing%20Patient%2DReported%20Outcomes%20(PROs,and%20treatment%20on%20their%20life. 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims 

Episode 48 - Site Monitoring, part 2

In this episode, we’re talking about the activities broadly referred to as “monitoring” in ICH GCP. We’re going to focus on site monitoring, because of a listener question - thanks very much Rashmi! This is part two (so go back and listen to part 1 if you haven't already), where we look at the detail of the things the monitor gets up to whilst on site (aka at the hospital or clinic) that we didn't cover in Ep 1. 
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
ICH GCP E6 R3

Episode 47 - Site Monitoring, part 1

In this episode, we’re talking about the activities broadly referred to as “monitoring” in ICH GCP. We’re going to focus on site monitoring, because of a listener question - thanks very much Rashmi! This is part one (part two will be released in a couple of weeks), where we introduce the concept of monitoring and get into the detail of some of the things the monitor gets up to whilst on site (aka at the hospital or clinic). 
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
ICH GCP E6 R3

Episode 46 - Elyse's Corner: PPE (Personal Protective Equipment)

In this episode, we’re back in Elyse’s corner (hooray!), and today, we’re talking about a topic we all probably had some exposure to during Covid but might not remember a lot about it - PPE, or Personal Protective Equipment
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://pmc.ncbi.nlm.nih.gov/articles/PMC10001160/
https://pmc.ncbi.nlm.nih.gov/articles/PMC11223943/
https://pmc.ncbi.nlm.nih.gov/articles/PMC8662528/ 
https://aging.networkofcare.org/riverside/CommunityResources/ClinicalTrials/Detail/NCT05369663?keyword=%22Speech%22 
https://pmc.ncbi.nlm.nih.gov/articles/PMC9190185/ 
https://pmc.ncbi.nlm.nih.gov/articles/PMC9845060/ 
https://bmcnurs.biomedcentral.com/articles/10.1186/s12912-024-02370-5 
https://pmc.ncbi.nlm.nih.gov/articles/PMC8111204/
 

Episode 45 - Contracting in Clinical Research

Alright so we’ve talked about contract research organisations and vendors and suppliers lots, but it’s time to put on our legal hats and discuss contracting! Why is it needed, why is it so widespread, which kinds of things can be contracted and what does GCP have to say about it. If this is what you want to know - you’re in the right place!
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 - ICH_E6(R3)_Step4_FinalGuideline_2025_0106.pdf