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 

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 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 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 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 -  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 

Today, we’re talking about the type of clinical staff that are often involved in Clinical Research - including Doctors, Nurses, Pharmacists and quite a few more! We’re going to consider what their work as part of research looks like, how it may differ from their usual clinical work and what the benefit is for them. 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/

It is finally time for our long awaited second Q&A episode! We throw questions at each other, though honestly Debbie does answer most of them. 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 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: Revolutionizing healthcare: the role of artificial intelligence in clinical practice -https://bmcmededuc.biomedcentral.com/articles/10.1186/s12909-023-04698-z Dosing by weight and the morning after pill - https://pmc.ncbi.nlm.nih.gov/articles/PMC4500687/  https://accpjournals.onlinelibrary.wiley.com/doi/abs/10.1002/j.1875-9114.2012.01108.x#:~:text=Dosing%20based%20on%20body%20weight,not%20increase%20with%20body%20size.

In this episode, we’re looking at another fundamental topic central to the conduct of clinical research, which is the Inclusion and Exclusion criteria that are used to determine if a patient is allowed to participate in a clinical trial (after they’ve consented, of course!) What kind of things are used to include or exclude patients, and why might there be a LOT of them? 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/

In this episode, we’re reprising some information we’ve talked generally about before, but with a new perspective -  how an average day looks for a site conducting clinical research. Spoiler alert - there’s no such thing as an average day for a clinical research site! 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/

For this episode, we’re taking an enormous detour from our normal content and diving into the philisophody or philisophities ravine, with our wonderful friend Andy. We talk about what philosophy is and why it is important to medical research, whilst investigating discussions around consent, cancer treatment, trauma and pain. Stay tuned at the end for an outtake right when we started recording :)  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/ Reading Andy recommends - "Writing History Writing Trauma" by Dominic LaCapra and "The Body in Pain" by Elaine Scarry

In this episode, we’re back in Elyse’s corner, and today, we’re talking about how governments and politics in general influence medical research and how it is conducted.  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 -  https://acrpnet.org/2024/08/15/the-politics-of-health-how-elections-will-impact-the-life-sciences  Research investment in the UK - https://www.gov.uk/government/news/uk-secures-400-million-investment-to-boost-clinical-trials  https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/how-clinical-trials-are-planned-and-organised/how-clinical-trials-are-funded   The articles Elyse referred to -  https://www.nature.com/articles/s41599-022-01269-3#Abs1 https://journals.sagepub.com/doi/full/10.1258/jrsm.2008.070373  https://pmc.ncbi.nlm.nih.gov/articles/PMC3487230/#sec1-5  https://pmc.ncbi.nlm.nih.gov/articles/PMC10741248/ https://pmc.ncbi.nlm.nih.gov/articles/PMC2739020/#b10 

We have looked previously at what is needed to start a study, and so today we’re learning what is needed at the other end, when a study is ending. What happens when the patients are completed and we’re trying to wrap everything up? How do studies end and what should be done at that point? Listen to find out! 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/

Returning for the second part of this episode, we start with recapping what we talked about in part 1 - although if you missed it you really should go back and listen to Ep30. We’re particularly looking at the healthcare impacts of inequality - why does it matter? And how these things are exacerbated by research. We hope you also note where our shiny rocks are appropriately polished to avoid any fines!  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 -  https://www.aamc.org/news/how-we-fail-black-patients-pain https://www.ncbi.nlm.nih.gov/pubmed/22239747  https://www.kingsfund.org.uk/insight-and-analysis/long-reads/what-are-health-inequalities#inequalities-in-life-expectancy https://www.ncbi.nlm.nih.gov/books/NBK584392/ https://pubmed.ncbi.nlm.nih.gov/37676096/ https://www.hra.nhs.uk/planning-and-improving-research/best-practice/people-centred-clinical-research/people-centred-clinical-research-infographic/  Books -  Invisible Women - Caroline Criado Perez Inflamed - Rupa Marya and Raj Patel Doing Harm - Maya Dusenbery Divided - Annabel Sowemimo