Intro to Clinical Research

It is finally time for another long awaited Q&A episode! Elyse is the questioner and Debbie does her best with the pre-researched and prepared answers. 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 suggestions into us! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ References - https://casp-uk.net/casp-tools-checklists/ http://www.understandinghealthresearch.org/# https://sites.google.com/nihr.ac.uk/pi-standards/home https://www.cochranelibrary.com/ https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/humanitarian-device-exemption https://www.fda.gov/emergency-preparedness-and-response/preparedness-research/animal-rule-information

In this episode, we’re talking about anti-microbial resistance (AMR). The episode will include what we mean by a pathogen, how they may become resistant, how that resistance spreads and what we can do about it. 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/sounds/play/w3ct6sxh https://www.ncbi.nlm.nih.gov/books/NBK513277/ https://www.who.int/news/item/14-06-2024-who-releases-report-on-state-of-development-of-antibacterials https://today.uic.edu/new-antibiotic-attacks-bacteria-in-never-before-seen-way/ https://warwick.ac.uk/news/pressreleases/new_antibiotic_for_drug_resistant_bacteria_found_hiding_in_plain_sight/ https://www.who.int/europe/news-room/fact-sheets/item/bacteriophages-and-their-use-in-combating-antimicrobial-resistance https://www.youtube.com/watch?v=NWo4MwE3zfU Meera Senthilingam - “Outbreaks & Pandemics”, particularly Chapter 6

It’s time for us to update you on current events, medical research or drugs in the news! We’ve got a few stories at different points in their research journey, from just getting started to failing publicly, and an update on regulation changes in the UK. 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/c4gllr5y3n2o https://www.theguardian.com/science/2026/may/30/cancer-jab-can-eradicate-entire-tumours-in-patients-trial-shows https://www.theguardian.com/science/2026/may/30/trial-of-multi-cancer-blood-test-among-142000-nhs-patients-fails-to-meet-main-aim https://www.legislation.gov.uk/uksi/2025/538 https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/clinical-trials-investigational-medicinal-products-ctimps/clinical-trial-regulations-reform/

Episode 60 In this episode, we’re back in Elyse’s corner (hooray!), and today, we’re talking about the interstitium (with a prelude into the human lymphatic system). Don’t worry if you have no clue what either of those things are, we’re doing a basic guide today but check out the references for much more info! 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.nature.com/articles/s41598-018-23062-6.pdf https://pmc.ncbi.nlm.nih.gov/articles/PMC6399417/ https://www.scientificamerican.com/article/meet-your-interstitium-a-newfound-organ/ https://www.nytimes.com/interactive/2026/05/11/magazine/interstitium-anatomy-acupuncture-medicine.html

This is part 2 of our discussion on interpretation of GCP. If you haven’t listened to part 1, I recommend going and checking that out first. We’re covering a few more examples where ICH GCP sets out the principles and practices that should be followed to have harmonised, quality 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/

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 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, 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 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.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 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/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 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/

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

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

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/

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