Intro to Clinical Research

Episode 60 - Elyse's Corner: The Interstitium

Mon, 06 Jul 2026 08:00:00 +0100

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 2

Mon, 15 Jun 2026 08:00:00 +0100

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.

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 1

Mon, 25 May 2026 08:00:00 +0100

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!

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

Episode 57 - Medical Ethics

Mon, 04 May 2026 08:00:00 +0100

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.

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 Collaboration

Mon, 13 Apr 2026 08:00:00 +0100

In this episode, we’re going to be discussing some international collaborations in clinical research! Let’s cross some borders and work together!

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 Brochure

Mon, 30 Mar 2026 08:00:00 +0100

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.

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

Episode 54 - Medical Devices

Mon, 22 Dec 2025 08:00:00 +0000

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!)

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 Vaccines

Mon, 06 Oct 2025 08:00:00 +0100

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!

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 Management

Mon, 22 Sep 2025 08:00:00 +0100

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!

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)

Mon, 08 Sep 2025 08:00:00 +0100

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.

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 stuff

Mon, 25 Aug 2025 08:00:00 +0100

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.

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 Outcomes

Mon, 11 Aug 2025 08:00:00 +0100

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.

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

Episode 48 - Site Monitoring, part 2

Mon, 28 Jul 2025 08:00:00 +0100

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.

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 1

Mon, 14 Jul 2025 08:00:00 +0100

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).

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)

Mon, 30 Jun 2025 08:00:00 +0100

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

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 Research

Mon, 16 Jun 2025 08:00:00 +0100

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!

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 News

Mon, 02 Jun 2025 08:00:00 +0100

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.

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!

Mon, 28 Apr 2025 08:00:00 +0100

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.

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 3

Mon, 14 Apr 2025 08:00:00 +0100

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.

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 - Pharmacovigilance

Mon, 31 Mar 2025 08:00:00 +0100

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!

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

Episode 40 - Avian Influenza

Mon, 17 Mar 2025 08:00:00 +0000

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?

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

Episode 39 - Clinicians in Clinical Research

Mon, 03 Mar 2025 08:00:00 +0000

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.

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!

Mon, 17 Feb 2025 08:00:00 +0000

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!

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 Eligibility

Mon, 03 Feb 2025 08:00:00 +0000

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?

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 Life

Mon, 20 Jan 2025 08:00:00 +0000

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!

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 Ravine

Mon, 06 Jan 2025 08:00:00 +0000

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 :)

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 Topic

Mon, 23 Dec 2024 08:00:00 +0000

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.

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 Study

Mon, 09 Dec 2024 08:00:00 +0000

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!

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 2

Mon, 25 Nov 2024 08:00:00 +0000

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!

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 Research

Mon, 11 Nov 2024 08:00:00 +0000

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!

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 1

Mon, 28 Oct 2024 08:00:00 +0000

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!

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 Advertising

Mon, 14 Oct 2024 08:00:00 +0100

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?

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 Interest

Mon, 30 Sep 2024 08:00:00 +0100

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.

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 Regulators

Mon, 16 Sep 2024 08:00:00 +0100

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.

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

Episode 26 - Ozempic

Mon, 02 Sep 2024 08:00:00 +0100

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.

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 News

Mon, 29 Jul 2024 08:00:00 +0100

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 - Cancer

Mon, 15 Jul 2024 08:00:00 +0100

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.

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: Temperature

Mon, 01 Jul 2024 08:00:00 +0100

In this episode, we’re back in Elyse’s corner, and it has some extremely shiny rocks! Today, we’re talking about temperature and how important it it to the delivery of research and successful medical treatment.

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

References -

https://www.cdc.gov/heat-health/hcp/heat-and-medications-guidance-for-clinicians.html

https://www.tandfonline.com/doi/full/10.1080/10903127.2016.1258098

https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf

https://www.sciencedirect.com/science/article/pii/S0939641117308731#b0175

https://www.who.int/teams/immunization-vaccines-and-biologicals/essential-programme-on-immunization/supply-chain/controlled-temperature-chain-(ctc)

https://www.sciencedirect.com/science/article/pii/S0264410X14000723

https://www.gpha.org/expired-vaccine-guidance-from-cdc/

https://aspr.hhs.gov/SNS/Pages/default.aspx

https://torontosun.com/news/national/feds-gets-new-covid-vaccines-as-1-5-b-worth-of-shots-expire-are-trashed

https://www.state.gov/covid-19-recovery/vaccine-deliveries/

https://www.who.int/news/item/29-11-2021-joint-statement-on-dose-donations-of-covid-19-vaccines-to-african-countries

Episode 22 - Who decides what is researched?

Mon, 17 Jun 2024 08:00:00 +0100

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

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 Up

Mon, 03 Jun 2024 08:00:00 +0100

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!

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 Research

Mon, 20 May 2024 08:00:00 +0100

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.

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

Episode 19 - Informed Consent

Mon, 06 May 2024 08:00:00 +0100

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!

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 Treatments

Mon, 22 Apr 2024 08:00:00 +0100

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)

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: CPR

Mon, 08 Apr 2024 08:00:00 +0100

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!

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-End

Mon, 25 Mar 2024 08:00:00 +0000

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!.

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

Episode 15 - Good Documentation Practice (GDP)

Mon, 11 Mar 2024 08:00:00 +0000

So it’s been 5 minutes since we talked about Debbie’s favourite topic documentation, so we’re back there to discuss Good Documentation Practice (GDP). What does that mean in real, clinical trial practice, what are some of the rules that need to be followed?

Here is the link to the FDA Warning letter sent to Amazon.com in December 2023 - https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amazoncom-inc-662503-12202023

AND! Debbie finally found the name of the drug that began with a “K” = Ketek, and the fraudulent enrollment https://www.nejm.org/doi/full/10.1056/NEJMp078032#:~:text=The%20study%20was%20completed%20in,complete%20fabrication%20of%20patient%20enrollment.

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

Episode 14 - Quality Assurance

Mon, 26 Feb 2024 08:00:00 +0000

How do we ensure (and assure) the quality of every part of the clinical trial process. Why do you even need quality assurance? What sorts of things do auditors or Inspectors find? That’s our topic for today’s episode, so be prepared to hear about what QA is and why it’s important.

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

Episode 13 - Questions and Answers

Mon, 12 Feb 2024 08:00:00 +0000

Unlucky for some, but for us we’re delighted - Episode 13 is our long awaited 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!

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

Episode 12 - Phenylephrine

Mon, 29 Jan 2024 08:00:00 +0000

In this episode, Debbie explains to Elyse all about phenylephrine and why it’s been in the news (and maybe not as obvious on your pharmacy shelves) in the last 6 months. What research was done when to get this drug onto the market, what the FDA have said recently and what may the next steps be going forwards.

We recommend you check out the FDA website to stay up to date on this issue, if you’re interested, since this episode was recorded a few weeks ago compared to when it is being released - https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-results-recent-advisory-committee-meeting-oral-phenylephrine

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 11 - Elyse’s Corner: Ketamine Therapy

Mon, 15 Jan 2024 08:00:00 +0000

Ep 11

In this episode, we’re back in Elyse’s corner, and it’s lovely! Elyse is going to tell Debbie all about Ketamine therapy and how it’s being researched as a potential treatment for major depressive disorder. A content warning for this episode - consider whether this episode is right for you to listen to, as there is discussion on mental health, depression and suicide. Please proceed with caution.

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 10 - Historical Stuff part 2

Mon, 01 Jan 2024 08:00:00 +0000

In this episode, Debbie is going to continue to tell Elyse about some tragedies in clinical trials, what occurred, what we learned and the consequences of them. This is part two of two linked episodes (this and the previous episode).

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 9 - Historical Stuff

Mon, 18 Dec 2023 08:00:00 +0000

In this episode, Debbie is going to tell Elyse about some tragedies in clinical trials, what occurred, what we learned and the consequences of them. This is part one of two linked episodes (this and the next episode).

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 8 - Documentation

Mon, 04 Dec 2023 08:00:00 +0000

In this episode, Debbie is going to tell Elyse about documentation and how important it is as both the instructions of how to do the study and evidence of what/ how it was actually done. Making sure that everything is documented is an important part of transparency. We hope you enjoy us nerding out about paperwork!

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 7 - Research Study Design

Mon, 20 Nov 2023 08:00:00 +0000

Ever wondered how new medicines become available at your Pharmacy or through your Doctor? Clinical Research is key to making this happen! In this episode, Debbie is going to tell Elyse about research study design, so we’re going to learn how it works to build a study from the ground up to meet their goal?

You can get in touch with us via clinical.research.intro@gmail.com

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

Episode 6 - Rules and Regulations

Mon, 06 Nov 2023 08:00:00 +0000

Ever wondered how new medicines become available at your Pharmacy or through your Doctor? Clinical Research is key to making this happen! In this episode, we’re talking about the rules, regulations and guidance in place to ensure research is done properly.

You can get in touch with us via clinical.research.intro@gmail.com

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

Episode 5 - Elyse’s Corner: Narcan

Mon, 23 Oct 2023 08:00:00 +0100

Ever wondered how new medicines become available at your Pharmacy or through your Doctor? Clinical Research is key to making this happen! In this episode, Elyse grabs the wheel and drives us (including Debbie!) through what Narcan is, and how it’s saving lives.

You can get in touch with us via clinical.research.intro@gmail.com

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

Episode 4 - FDA Accelerated Approval Program

Mon, 09 Oct 2023 08:00:00 +0100

Ever wondered how new medicines become available at your Pharmacy or through your Doctor? Clinical Research is key to making this happen! In this episode, Debbie and Elyse explore the question, "How come some medicines get to jump the queue, and get approved through that accelerated approval program?"

You can get in touch with us via clinical.research.intro@gmail.com

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

Episode 3 - Phases

Mon, 25 Sep 2023 08:00:00 +0100

You can get in touch with us via clinical.research.intro@gmail.com

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

Episode 2 - Research Development

Mon, 11 Sep 2023 15:18:01 +0100

Ever wondered how new medicines become available at your Pharmacy or through your Doctor? Clinical Research is key to making this happen! In this episode, Debbie and Elyse explore the question, "what are the parts of the process and who is involved?"

You can get in touch with us via clinical.research.intro@gmail.com

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

Introduction to Clinical Research!

Mon, 28 Aug 2023 19:07:39 +0100

Have you ever wondered how new medicines become available at your Pharmacy or through your Doctor? Clinical Research is a key step in making this happen! In this podcast, Debbie and Elyse explore the question, "what is clinical research?"

You can get in touch with us via clinical.research.intro@gmail.com

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/