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Explore every episode of the podcast Intro to Clinical Research

Dive into the complete episode list for Intro to Clinical Research. Each episode is cataloged with detailed descriptions, making it easy to find and explore specific topics. Keep track of all episodes from your favorite podcast and never miss a moment of insightful content.

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TitlePub. DateDuration
Episode 65 - Site Selection19 Oct 202601:06:59

In this episode, we’re talking about Site Selection, which means how it is decided which clinical locations should conduct a clinical study. If you haven’t already, before we get into this episode I really recommend you check out Ep 16 (End to end of a study for a rapid paced overview of a study from beginning to end), Ep 21 (Site start up) and Ep 36 (A day in the life of a research site) to get the idea of what we’re talking about in the wider context.

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 64 - Generic Medicines28 Sep 202600:39:22

In this episode, we’re talking about generic medicines. We’re going to outline what they are, how they end up on the market and perhaps in your medicine cabinet and the advantages/ disadvantages 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/

References -  

https://www.thebureauinvestigates.com/stories/2025-06-25/what-are-generic-drugs-and-are-they-safe

https://www.ummhealth.org/simply-well/the-pros-and-cons-of-using-generic-drugs

https://www.moneysavingexpert.com/news/2016/06/revealed-huge-price-differences-between-branded-and-own-brand-medicines-and-generic-equivalents/

Episode 63 - Q & A Again07 Sep 202600:46:24

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 

 

Episode 62 -Antimicrobial Resistance (AMR)17 Aug 202600:55:04

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

Episode 61 - Research in the News27 Jul 202600:46:10

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 - Elyse's Corner: The Interstitium06 Jul 202600:57:32

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

Episode 59 - Interpretation of ICH GCP part 215 Jun 202600:49:00

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/

Episode 58 - Interpretation of ICH GCP part 125 May 202600:51:24

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/

Episode 57 - Medical Ethics04 May 202600:50:52

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

Episode 56 - International Collaboration13 Apr 202600:51:31

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

Episode 55 - Safety Events & Investigator's Brochure30 Mar 202600:54:17

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/

Episode 54 - Medical Devices22 Dec 202500:48:44

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 Vaccines06 Oct 202500:57:03

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 Management22 Sep 202501:00:18

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)08 Sep 202500:51:57

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 stuff25 Aug 202500:29:13

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 Outcomes11 Aug 202500:55:36
Episode 48 - Site Monitoring, part 228 Jul 202501:00:20

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 114 Jul 202500:54:55

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)30 Jun 202501:05:28

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 Research16 Jun 202500:54:16

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

Episode 44 - Research in the News02 Jun 202500:50:57

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 

Episode 43 - ICH GCP (R3): The New Version for 2025!28 Apr 202500:47:59

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 - Historical Stuff part 314 Apr 202500:44:06

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 

Episode 41 - Pharmacovigilance31 Mar 202500:55:45

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 - Avian Influenza17 Mar 202500:54:41
Episode 39 - Clinicians in Clinical Research03 Mar 202500:56:38

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/

Episode 38 - Questions and Answers AGAIN!17 Feb 202500:55:04

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.

Episode 37 - Patient Eligibility03 Feb 202500:51:44

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/

Episode 36 - A Research Site: A Day in the Life20 Jan 202500:52:57

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/

Episode 35 - The Philosophy Ravine06 Jan 202501:03:16

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

Episode 34 - Elyse's Corner: The Forbidden Topic23 Dec 202401:03:27

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 

Episode 33 - The End of a Study09 Dec 202400:53:30

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/

Episode 32 - Prejudice, Discrimination and Healthcare Impact Part 225 Nov 202400:55:49

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 

Episode 31 - Technology in Clinical Research11 Nov 202401:01:57

What is technology and how is it used in research? How can we, or should we, be using all of the data collected about us for research, and what are the ethical dangers of this? What rules are in place around the handling of our healthcare data? All questions we try and tackle in this episode. We’ll get back to Prejudice, discrimination and healthcare impacts next time!

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://ourfuturehealth.org.uk/ 

https://healthdatagateway.org/en

Episode 30 - Prejudice, Discrimination and Healthcare Impacts part 128 Oct 202400:59:25

Do we have an equitable or equal society? What even do those words mean? And why do we care - what possible impacts could those things have on people and/ or their healthcare outcomes? The answer - A LOT! We start to tackle this in this episode, part 1, with more to follow in part 2! Also, keep your ears peeled for a very brief outing for 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/

Resources - 

https://www.aamc.org/news/how-we-fail-black-patients-pain

https://www.ncbi.nlm.nih.gov/pubmed/22239747 

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

Episode 29 - Elyse's Corner: Drug Advertising14 Oct 202401:04:40

In this episode, we’re back in Elyse’s corner, with the marvellous shiny rocks, which today will go unpolished! Instead, we’re talking about direct to consumer advertising for prescription and over the counter drugs - the history of it, and why does it happen in such a limited number of places worldwide? 

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 - 

Direct-To-Consumer Prescription Drug Advertising: Trends, Impact, And Implications

Pharma and healthcare industry advertising in the U.S. - statistics & facts

Ad spending in dietary supplements category

How advertisers are building up their cannabis ad budgets

Manufacturer Spending on Direct-to-Consumer Advertising for Pharmaceutical Products

AMA press release Nov 2015

Advertising and the promotion of medicines in the UK

Episode 28 - Conflict of Interest30 Sep 202400:52:01

What is a conflict of interest and why might it be important? In this episode we briefly define what a COI is, and explore some examples around medical research and what the impact may be. 

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/

GMC Guidance - https://www.gmc-uk.org/-/media/gmc-site/ethical-guidance/mdg-2023/identifying-and-managing-conflicts-of-interest-english.pdf

MHRA Board Members receiving payments from Pharma - https://www.theguardian.com/society/2022/apr/17/medical-regulator-faces-questions-over-board-members-links-to-drug-firms

MHRA 2022 COI Report - https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1173562/Annual_Compliaince_Report_2022.pdf

Episode 27 - Government Regulators16 Sep 202400:57:57

A question that has stood since time immemorial. What DO government regulators do, when it comes to drugs and devices? Hopefully, this episode will give you some answers to that question! Debbie attempts to tell Elyse about Government regulators, but in the process, does forget her own name and how to say thank you successfully. 

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 26 - Ozempic02 Sep 202400:33:47

Welcome back from our summer break! Today, a shorter episode looking at the use of Ozempic/ Wegovy (brand names) - type II diabetes semiglutide drugs, because they’re all over the news media at the moment. Living in the most fatphobic bit of the world and discussing it made us feel not great, which is why the episode is shorter today. We also talk about the ban on puberty blockers in the UK, drawing some interesting parallels between that and Ozempic. 

Content Warnings - fatphobia & diet culture, weightloss, death by suicide, transphobia. 

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.theguardian.com/society/article/2024/jun/13/top-doctor-warns-against-using-anti-obesity-drugs-to-get-beach-body-ready 

https://www.maintenancephase.com/

https://www.yourfatfriend.com/

Episode 25 - Drugs in the News29 Jul 202401:03:32

Today, Elyse and Debbie are putting their finger on the pulse of THE NEWS around clinical research, drugs, science, health - as much news as you could want! We’re going to take it in turns and share with each other - and you - 2 stories each that we’ve seen in the news recently. And then at the end, we go on a tangent about racism and imperialism and white supremacy, you know what we’re like by now. 

Also, just to let you know, Elyse & I will be taking a summer holiday - which means no new episodes for August. See you in September! Feel free to send in questions or suggestions if you miss us too badly!

Resources

Debbie Story 1 - IBD - https://www.theguardian.com/society/article/2024/jun/05/bowel-disease-hope-researchers-find-biological-pathway

Elyse story 1 - Covid vaccines 

https://www.forbes.com/sites/ariannajohnson/2024/05/22/covids-new-flirt-variants-what-to-know-as-experts-fear-summer-surge/?sh=59372a3dd705

https://www.forbes.com/sites/ariannajohnson/2024/06/05/fda-panel-recommends-new-covid-vaccines-for-jn1-lineage-by-fall/

https://www.fda.gov/advisory-committees/advisory-committee-calendar/postponed-vaccines-and-related-biological-products-advisory-committee-may-16-2024-meeting 

https://www.who.int/news/item/26-04-2024-statement-on-the-antigen-composition-of-covid-19-vaccines 

Debbie Story 2 - lung cancer 

https://www.theguardian.com/society/article/2024/may/31/trial-results-for-new-lung-cancer-drug-are-off-the-charts-say-doctors

https://clinicaltrials.gov/study/NCT03052608

Elyse Story 2 - Hair Relaxers 

https://www.nytimes.com/2023/10/16/health/hair-straighteners-black-women-fda.html 

https://www.nytimes.com/2024/06/13/magazine/hair-relaxers-cancer-risk.html 

https://pubmed.ncbi.nlm.nih.gov/36245087/ 

Episode 24 - Cancer15 Jul 202401:02:23

Today’s topic is not a fun one, but is something many of us have experience with - we’re talking about cancer - what causes it, how it works, and how it’s treated. Once we’ve got the science part out of the way, we’ll look at how complex and interesting cancer research 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/

References - 

Hank Green’s blog on cancer - https://youtu.be/rCo71uX_pCI?si=0Gv2eEg8J5ZL7s0p

Hank Green’s chemo vlog - https://youtu.be/ceF4GxVkOqA?si=fynv30g5hynlKB58

Episode 23 - Elyse's Corner: Temperature01 Jul 202401:03:00
Episode 22 - Who decides what is researched?17 Jun 202400:54:19

As members of the public how can we influence what is developed? Who is making the decisions about which new medicines and products get researched? That’s the topic for today, and I’m afraid it’s not great news, everyone!

References - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7841468/

https://researchsupport.admin.ox.ac.uk/equity-and-inclusivity-in-research-funding

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 21 - Site Start Up03 Jun 202400:57:14

Getting a clinical trial site (or sites) ready to start is a busy, hectic and high pressure time and the focus of our episode today. What is needed, how the items interlock and overlap, and who is responsible!

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 20 - Careers in Clinical Research20 May 202401:00:12

Ever thought about a career in clinical research? In this episode that’s exactly what we’re talking about - what the options are, what you need to know, and what transferable skills you need. 

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 19 - Informed Consent06 May 202400:49:15

Today, we’re talking about Informed Consent - what it is, how it works, how it's documented and how it is handled for different people. This is a whistle-stop tour covering the main principles and points, but as always we could talk for hours about this topic!

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 18 - Issues with Treatments22 Apr 202401:07:42

In this episode, we’re talking about some issues with treatments. We’re looking at some drugs that have lost or might lose their approvals, or cases where additional measures are put in place for safety reasons. 

Here are some resources or references used in the research for this episode - 

Crizanlizumab statement. January 2024 » Sickle Cell Society

Crizanlizumab - end of NHS supply » Sickle Cell Society

FDA starts speedy review of Novartis’ sickle cell antibody - PMLiVE

Exa-Cel (Casgevy) Gene Therapy Update » Sickle Cell Society

Montelukast (Singulair): reminder of the risk of neuropsychiatric reactions - GOV.UK (www.gov.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/

Episode 17 - Elyse's Corner: CPR08 Apr 202401:01:19

In this episode, we’re back in Elyse’s corner, and it has far fewer cobwebs - someone has been dusting! Elyse is going to tell Debbie all about CPR - how it works, how well it works, and we’re going to discover together how it’s possible to do research around something like CPR when the patient is unconscious! 

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 16 - Study End-to-End25 Mar 202401:05:33

We’ve covered a lot of topics so far, so today we’re recapping what we’ve discussed already AND looking at the end of end of a clinical study - from about 10000 feet! We do want to dive in more to some areas in detail, but for now, it’s a sprint through from beginning to end!. 

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/

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