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Episode 36 - A Research Site: A Day in the Life
Manage episode 462093917 series 3506573
Content provided by Debbie and Elyse. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Debbie and Elyse or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
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/
44 episodes
ShareManage episode 462093917 series 3506573
Content provided by Debbie and Elyse. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Debbie and Elyse or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
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/
44 episodes
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Intro to Clinical Research
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…
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Intro to Clinical Research
1 Episode 43 - ICH GCP (R3): The New Version for 2025! 47:59
47:59 Play Later Play Later Lists Like Liked47:59
Play Later Play Later Lists Like LikedYou 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…
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Intro to Clinical Research
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…
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Intro to Clinical Research
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/…
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Intro to Clinical Research
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…
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Intro to Clinical Research
1 Episode 39 - Clinicians in Clinical Research 56:38
56:38 Play Later Play Later Lists Like Liked56:38
Play Later Play Later Lists Like LikedToday, 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/…
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Intro to Clinical Research
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.…
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Intro to Clinical Research
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/…
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Intro to Clinical Research
1 Episode 36 - A Research Site: A Day in the Life 52:57
52:57 Play Later Play Later Lists Like Liked52:57
Play Later Play Later Lists Like LikedIn 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/…
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Intro to Clinical Research
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…
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Intro to Clinical Research
1 Episode 34 - Elyse's Corner: The Forbidden Topic 1:03:27
1:03:27 Play Later Play Later Lists Like Liked1:03:27
Play Later Play Later Lists Like LikedIn 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…
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Intro to Clinical Research
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/…
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Intro to Clinical Research
1 Episode 32 - Prejudice, Discrimination and Healthcare Impact Part 2 55:49
55:49 Play Later Play Later Lists Like Liked55:49
Play Later Play Later Lists Like LikedReturning 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…
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Intro to Clinical Research
1 Episode 31 - Technology in Clinical Research 1:01:57
1:01:57 Play Later Play Later Lists Like Liked1:01:57
Play Later Play Later Lists Like LikedWhat 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…
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Intro to Clinical Research
1 Episode 30 - Prejudice, Discrimination and Healthcare Impacts part 1 59:25
59:25 Play Later Play Later Lists Like Liked59:25
Play Later Play Later Lists Like LikedDo 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…
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Intro to Clinical Research
1 Episode 29 - Elyse's Corner: Drug Advertising 1:04:40
1:04:40 Play Later Play Later Lists Like Liked1:04:40
Play Later Play Later Lists Like LikedIn 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…
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Intro to Clinical Research
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…
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Intro to Clinical Research
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/…
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Intro to Clinical Research
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/…
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Intro to Clinical Research
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/…
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Intro to Clinical Research
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…
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Intro to Clinical Research
1 Episode 23 - Elyse's Corner: Temperature 1:03:00
1:03:00 Play Later Play Later Lists Like Liked1:03:00
Play Later Play Later Lists Like LikedIn 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…
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Intro to Clinical Research
1 Episode 22 - Who decides what is researched? 54:19
54:19 Play Later Play Later Lists Like Liked54:19
Play Later Play Later Lists Like LikedAs 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/…
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Intro to Clinical Research
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/…
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Intro to Clinical Research
1 Episode 20 - Careers in Clinical Research 1:00:12
1:00:12 Play Later Play Later Lists Like Liked1:00:12
Play Later Play Later Lists Like LikedEver 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/…
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Intro to Clinical Research
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/…
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Intro to Clinical Research
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/…
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Intro to Clinical Research
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/…
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Intro to Clinical Research
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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Intro to Clinical Research
1 Episode 15 - Good Documentation Practice (GDP) 44:04
44:04 Play Later Play Later Lists Like Liked44:04
Play Later Play Later Lists Like LikedSo 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/…
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