Intro to Clinical Research

Intro to Clinical Research

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Welcome to the Introduction to Clinical Research Podcast! Join Debbie, a clinical research professional, as she explains clinical research to her friend Elyse. Curious how the COVID vaccine was developed so quickly? Ever wondered what rules determine when you can get a new drug? Remember that one miracle drug they swore would cure cancer back in 2002 but then you never heard of it again? Let’s talk about that.

Debbie and Elyse


    • Apr 28, 2025 LATEST EPISODE
    • every other week NEW EPISODES
    • 56m AVG DURATION
    • 43 EPISODES


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    Latest episodes from Intro to Clinical Research

    Episode 43 - ICH GCP (R3): The New Version for 2025!

    Play Episode Listen Later Apr 28, 2025 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 3

    Play Episode Listen Later Apr 14, 2025 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 - Pharmacovigilance

    Play Episode Listen Later Mar 31, 2025 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 Influenza

    Play Episode Listen Later Mar 17, 2025 54:41


    Episode 40 In this episode, we're back in Elyse's corner (hooray!), and today, we're talking about a hot topic in the US: Bird flu. AKA why my eggs so spensy? Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It's fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ Resources/ references -  https://www.tandfonline.com/doi/full/10.1080/21505594.2024.2343931?src=recsys https://respiratory-therapy.com/products-treatment/pharmaceuticals/clinical-trials/fda-oks-phase-1-trial-mrna-vaccine-h5n1-avian-flu/ https://www.tandfonline.com/doi/full/10.1586/14760584.2013.811178 https://pmc.ncbi.nlm.nih.gov/articles/PMC9027673/ https://www.clinicaltrialsarena.com/news/traws-trials-h5n1-drug/?cf-view&cf-closed https://www.efsa.europa.eu/en/topics/topic/avian-influenza https://efsa.onlinelibrary.wiley.com/doi/full/10.2903/j.efsa.2025.9191 https://www.wattagnet.com/poultry-meat/diseases-health/avian-influenza/article/15707933/avian-flu-confirmed-on-poultry-farms-in-13-european-countries  https://www.cdc.gov/media/releases/2025/m0106-h5-birdflu-death.html 

    Episode 39 - Clinicians in Clinical Research

    Play Episode Listen Later Mar 3, 2025 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!

    Play Episode Listen Later Feb 17, 2025 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 Eligibility

    Play Episode Listen Later Feb 3, 2025 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 Life

    Play Episode Listen Later Jan 20, 2025 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 Ravine

    Play Episode Listen Later Jan 6, 2025 63:16


    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 Topic

    Play Episode Listen Later Dec 23, 2024 63:27


    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 Study

    Play Episode Listen Later Dec 9, 2024 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 2

    Play Episode Listen Later Nov 25, 2024 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 30 - Technology in Clinical Research

    Play Episode Listen Later Nov 11, 2024 61:57


    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 1

    Play Episode Listen Later Oct 28, 2024 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 Advertising

    Play Episode Listen Later Oct 14, 2024 64:40


    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 Interest

    Play Episode Listen Later Sep 30, 2024 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 Regulators

    Play Episode Listen Later Sep 16, 2024 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 - Ozempic

    Play Episode Listen Later Sep 2, 2024 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 News

    Play Episode Listen Later Jul 29, 2024 63:32


    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 - Cancer

    Play Episode Listen Later Jul 15, 2024 62:23


    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: Temperature

    Play Episode Listen Later Jul 1, 2024 63:00


    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. 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.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?

    Play Episode Listen Later Jun 17, 2024 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 Up

    Play Episode Listen Later Jun 3, 2024 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 Research

    Play Episode Listen Later May 20, 2024 60:12


    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 Consent

    Play Episode Listen Later May 6, 2024 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 Treatments

    Play Episode Listen Later Apr 22, 2024 67:42


    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: CPR

    Play Episode Listen Later Apr 8, 2024 61:19


    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-End

    Play Episode Listen Later Mar 25, 2024 65:33


    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/

    Episode 15 - Good Documentation Practice (GDP)

    Play Episode Listen Later Mar 11, 2024 44:04


    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. 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 14 - Quality Assurance

    Play Episode Listen Later Feb 26, 2024 61:48


    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.  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 13 - Questions and Answers

    Play Episode Listen Later Feb 12, 2024 54:23


    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!  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 12 - Phenylephrine

    Play Episode Listen Later Jan 29, 2024 47:38


    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

    Play Episode Listen Later Jan 15, 2024 65:41


    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

    Play Episode Listen Later Jan 1, 2024 66:01


    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).  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.  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

    Play Episode Listen Later Dec 18, 2023 65:19


    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).  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.  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

    Play Episode Listen Later Dec 4, 2023 52:19


    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

    Play Episode Listen Later Nov 20, 2023 61:56


    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

    Play Episode Listen Later Nov 6, 2023 54:26


    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

    Play Episode Listen Later Oct 23, 2023 52:47


    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

    Play Episode Listen Later Oct 9, 2023 47:43


    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

    Play Episode Listen Later Sep 25, 2023 63:26


    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 study phases?" 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

    Play Episode Listen Later Sep 11, 2023 65:48


    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!

    Play Episode Listen Later Aug 28, 2023 48:51


    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/

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