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Intro to Clinical Research

Debbie and Elyse
Intro to Clinical Research
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5 van 49
  • Episode 49 - Patient Reported Outcomes
    Today, we’re discussing patient reported outcomes - what are they, how can they be measured and how do they compare to other measures we often use to measure the success (or not) of research.  Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ References https://www.jmir.org/2020/3/e12689/  https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-18#:~:text=A%20patient%2Dreported%20outcome%20(PRO,(Powers%20et%20al%202017).  https://www.gov.uk/guidance/patient-reported-outcomes-and-experiences-study#:~:text=Broadly%2C%20PROMs%20evaluate%20either%20the,pain%20or%20discomfort https://www.birmingham.ac.uk/research/centres-institutes/patient-reported-outcomes/prolearn/pros-in-trials#:~:text=Capturing%20Patient%2DReported%20Outcomes%20(PROs,and%20treatment%20on%20their%20life.  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims 
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  • Episode 48 - Site Monitoring, part 2
    In this episode, we’re talking about the activities broadly referred to as “monitoring” in ICH GCP. We’re going to focus on site monitoring, because of a listener question - thanks very much Rashmi! This is part two (so go back and listen to part 1 if you haven't already), where we look at the detail of the things the monitor gets up to whilst on site (aka at the hospital or clinic) that we didn't cover in Ep 1.  Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ References ICH GCP E6 R3
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  • Episode 47 - Site Monitoring, part 1
    In this episode, we’re talking about the activities broadly referred to as “monitoring” in ICH GCP. We’re going to focus on site monitoring, because of a listener question - thanks very much Rashmi! This is part one (part two will be released in a couple of weeks), where we introduce the concept of monitoring and get into the detail of some of the things the monitor gets up to whilst on site (aka at the hospital or clinic).  Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ References ICH GCP E6 R3
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  • Episode 46 - Elyse's Corner: PPE (Personal Protective Equipment)
    In this episode, we’re back in Elyse’s corner (hooray!), and today, we’re talking about a topic we all probably had some exposure to during Covid but might not remember a lot about it - PPE, or Personal Protective Equipment Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ References https://pmc.ncbi.nlm.nih.gov/articles/PMC10001160/ https://pmc.ncbi.nlm.nih.gov/articles/PMC11223943/ https://pmc.ncbi.nlm.nih.gov/articles/PMC8662528/  https://aging.networkofcare.org/riverside/CommunityResources/ClinicalTrials/Detail/NCT05369663?keyword=%22Speech%22  https://pmc.ncbi.nlm.nih.gov/articles/PMC9190185/  https://pmc.ncbi.nlm.nih.gov/articles/PMC9845060/  https://bmcnurs.biomedcentral.com/articles/10.1186/s12912-024-02370-5  https://pmc.ncbi.nlm.nih.gov/articles/PMC8111204/  
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  • Episode 45 - Contracting in Clinical Research
    Alright so we’ve talked about contract research organisations and vendors and suppliers lots, but it’s time to put on our legal hats and discuss contracting! Why is it needed, why is it so widespread, which kinds of things can be contracted and what does GCP have to say about it. If this is what you want to know - you’re in the right place! Remember, you can get in touch with us via [email protected]. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ References - ICH_E6(R3)_Step4_FinalGuideline_2025_0106.pdf
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Over Intro to Clinical Research

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.
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