Intro to Clinical Research

This is part 2 of our discussion on interpretation of GCP. If you haven’t listened to part 1, I recommend going and checking that out first. We’re covering a few more examples where ICH GCP sets out the principles and practices that should be followed to have harmonised, quality research. Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

Today, Debbie throws us all back into the Philosophy Ravine together to discuss medical ethics. We’re going to talk about what it is and use the framework of Medical Ethics to consider two case studies - the Minnesota Starvation Experiments and Covid-19 Challenge Studies. Content Warning - this podcast does discuss WW2, and experiments where patients chose to restrict their access to food. Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ References - https://www.bmj.com/content/371/bmj.m4258#:~:text=In%20the%20current%20pandemic%2C%20over%2038%20000,a%20non%2Dprofit%20organisation%20advocating%20for%20these%20volunteers https://www.bbc.co.uk/news/health-56097088#:~:text=Getty%20Images,more%20than%2015%20million%20people. https://www.pushkin.fm/podcasts/revisionist-history/the-rise-of-the-guinea-pigs https://thispodcastwillkillyou.com/2025/10/14/episode-190-starvation-more-than-hunger/ Firsthand: The Minnesota semi-starvation experiment, University Publications, Archives & Special Collections, Colorado State University https://hdl.handle.net/10217/02.0036381

Hey everyone! We’re back (again!) and we hope you didn’t miss us too much. In this episode, we’re going to be discussing safety events, safety reporting and the compilation of information in the Investigator’s Brochure. Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/

In this episode, we’re back in Elyse’s corner (hooray!), and today, we’re talking about Anthrax, and Anthrax vaccines. Maybe you know as little about it as Debbie, or maybe you know loads, but as always, Elyse is going to guide us through this topic from her goblin corner! Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ References https://www.ncbi.nlm.nih.gov/books/NBK220522/ https://www.cdc.gov/anthrax/prevention/index.html https://blogs.cdc.gov/niosh-science-blog/2022/04/21/welders-anthrax/ https://www.cnn.com/2024/05/05/us/how-it-really-happened-anthrax-attacks https://pmc.ncbi.nlm.nih.gov/articles/PMC7993152/ https://journalofethics.ama-assn.org/article/informed-consent-military-anthrax-vaccination-case/2007-10 https://www.fbi.gov/history/famous-cases/amerithrax-or-anthrax-investigation https://www.sciencedirect.com/science/article/abs/pii/S0264410X22010453 https://pmc.ncbi.nlm.nih.gov/articles/PMC6147967/ https://ajph.aphapublications.org/doi/full/10.2105/AJPH.92.5.715 https://clearinghouse.net/doc/40458/ https://web.archive.org/web/20171114165441/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474027.htm https://web.archive.org/web/20171114200815/https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMRegulatoryScience/ucm391665.htm https://www.fda.gov/vaccines-blood-biologics/vaccines/biothrax

Today, we’re going to discuss Good Manufacturing Practice - GMP - which is like GCP but for the manufacturing of drugs, devices, food and cosmetics rather than the clinical processes involved in research. Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ References - https://database.ich.org/sites/default/files/Q7%20Guideline.pdf https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice https://pmc.ncbi.nlm.nih.gov/articles/PMC7395820/ Maintenance Phase Episode - https://open.spotify.com/episode/2iqRW5kzS02w4HRi6vOi6Q

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 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.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

In this episode, we’re talking about the activities broadly referred to as “monitoring” in ICH GCP. We’re going to focus on site monitoring, because of a listener question - thanks very much Rashmi! This is part one (part two will be released in a couple of weeks), where we introduce the concept of monitoring and get into the detail of some of the things the monitor gets up to whilst on site (aka at the hospital or clinic). Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ References ICH GCP E6 R3

Alright so we’ve talked about contract research organisations and vendors and suppliers lots, but it’s time to put on our legal hats and discuss contracting! Why is it needed, why is it so widespread, which kinds of things can be contracted and what does GCP have to say about it. If this is what you want to know - you’re in the right place! Remember, you can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Debbie squirm! Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/ References - ICH_E6(R3)_Step4_FinalGuideline_2025_0106.pdf

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

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/

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/

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/

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