Advertise on podcast: Intro to Clinical Research

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 

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 [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.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   

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 [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 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 [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://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 [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 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 [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.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 [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 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 [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 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 [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://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 [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 - 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 [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/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 [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/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 [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/ 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 

Pharmacovigilance is a big work that we’re going to break down in this episode, to look at the data around safety events, or patient experienced side effects in clinical trials and after a drug is on the market. Where does the data come from, and what is done with it. We are going to dive into the WHO definition of pharmacovigilance, and look out for a special appearance from our favourite shiny rock! 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/

Episode 40 In this episode, we’re back in Elyse’s corner (hooray!), and today, we’re talking about a hot topic in the US: Bird flu. AKA why my eggs so spensy? 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/ Resources/ references -  https://www.tandfonline.com/doi/full/10.1080/21505594.2024.2343931?src=recsys https://respiratory-therapy.com/products-treatment/pharmaceuticals/clinical-trials/fda-oks-phase-1-trial-mrna-vaccine-h5n1-avian-flu/ https://www.tandfonline.com/doi/full/10.1586/14760584.2013.811178 https://pmc.ncbi.nlm.nih.gov/articles/PMC9027673/ https://www.clinicaltrialsarena.com/news/traws-trials-h5n1-drug/?cf-view&cf-closed https://www.efsa.europa.eu/en/topics/topic/avian-influenza https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2025.9191 https://www.wattagnet.com/poultry-meat/diseases-health/avian-influenza/article/15707933/avian-flu-confirmed-on-poultry-farms-in-13-european-countries  https://www.cdc.gov/media/releases/2025/m0106-h5-birdflu-death.html