Intro to Clinical Research

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 

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/

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 

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

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

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/
 

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

It’s time for us to update you on current events, medical research or drugs in the news! We’ve got a couple of stories from Debbie and an update on our favourite shiny rock from Elyse. 
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.bbc.co.uk/news/articles/cy48jynpm8wo
https://www.nature.com/articles/s41586-025-08771-z 
https://www.theguardian.com/commentisfree/2025/may/09/male-bias-medical-trials-women-lives-data-gap 
Maya Dusenbery - Doing Harm (Book)
https://www.nejm.org/doi/full/10.1056/NEJMsb2506929 (FDA article)
https://apnews.com/article/vaccines-fda-kennedy-covid-shots-rfk-trump-bb4de15b6ff955d6cd0b406aaec3cdc5 
https://www.sciencealert.com/expert-explains-fdas-new-covid-vaccine-rules-in-the-us 

You may have heard us talk about GCP before, the international standard for the conduct of clinical studies globally. But, there’s a new version on the block! This episode is all about why the changes were needed and how they look in practice. 
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/documents/scientific-guideline/ich-e6-r3-guideline-good-clinical-practice-gcp-step-5_en.pdf 
 

Episode 42
In this episode, the unexpected third part in our “Historical Stuff” series, Debbie is going to tell Elyse about some tragedies in clinical trials, what occurred, what we learned and the consequences of them.  
So, heads up, definitely a content warning for this episode, it will include medical outcomes, death (including deaths of children), fetal development, torture, unethical conduct, medical racism (racism in general) - just a whole mixed bag of really terrible stuff. If that doesn’t sound like something you want to listen to, feel free to give this one a miss. 
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/
Resources/ references - 
Japan & Atomic Bomb experiments - https://web.archive.org/web/20130210011533/http://docs8.chomikuj.pl/2097817100,PL,0,0,Hiroshima---Atomic-Victims-as-Human-Guinea-Pigs-(criminal-Japan%E2%80%99s-National-Institute-of-Health-(JNIH)-Prof.-Shingo-Shibata-1996).pdf 
Nigeria & Pfizer - https://pmc.ncbi.nlm.nih.gov/articles/PMC1119465/ 
https://www.washingtonpost.com/wp-dyn/content/article/2006/05/06/AR2006050601338.html 
Puerto Rico & Contraceptive Pill - https://www.pbs.org/wgbh/americanexperience/features/pill-puerto-rico-pill-trials/ 
Retinoids podcast - https://podcasts.apple.com/gb/podcast/ep-156-retinoids-part-1-how-it-started/id1299915173?i=1000675737651 
Research misconduct (actual and alleged) https://www.ncbi.nlm.nih.gov/books/NBK475955/ 
Stolen: Surviving St Michael’s https://open.spotify.com/episode/2BllRP1ZQRKq2lxfpLUhzA