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...
Jul 14, 2025•55 min•Ep. 47
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. Chec...
Jun 30, 2025•1 hr 5 min•Ep. 46
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...
Jun 16, 2025•54 min•Ep. 45
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 [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.samwinn...
Jun 02, 2025•51 min•Ep. 44
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 [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 ...
Apr 28, 2025•48 min•Ep. 43
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’...
Apr 14, 2025•44 min•Ep. 42
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 [email protected] . Please feel free...
Mar 31, 2025•56 min•Ep. 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 [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/ Resources/ referen...
Mar 17, 2025•55 min•Ep. 40
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 [email protected] . Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun ...
Mar 03, 2025•57 min•Ep. 39
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 [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 Winn...
Feb 17, 2025•55 min•Ep. 38
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 [email protected] . Please feel free to send questions, comments an...
Feb 03, 2025•52 min•Ep. 37
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 [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 W...
Jan 20, 2025•53 min•Ep. 36
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 [email protected] . Please feel free to se...
Jan 06, 2025•1 hr 3 min•Ep. 35
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 [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/ Resourc...
Dec 23, 2024•1 hr 3 min•Ep. 34
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 [email protected] . Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make...
Dec 09, 2024•54 min•Ep. 33
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 [email protected] . Please feel fre...
Nov 25, 2024•56 min•Ep. 32
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 [email protected] . Please feel free to send questions, comments and ...
Nov 11, 2024•1 hr 2 min•Ep. 31
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 [email protected] . Please feel free to send questions, comments and compl...
Oct 28, 2024•59 min•Ep. 30
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 [email protected] . Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It’s fun to make Deb...
Oct 14, 2024•1 hr 5 min•Ep. 29
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 [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.sam...
Sep 30, 2024•52 min•Ep. 28
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 [email protected] . Please feel free to send questions, comments and compliments for Elyse to read out on the ...
Sep 16, 2024•58 min•Ep. 27
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 cult...
Sep 02, 2024•34 min•Ep. 26
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 ep...
Jul 29, 2024•1 hr 4 min•Ep. 25
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 [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...
Jul 15, 2024•1 hr 2 min•Ep. 24
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 [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 w...
Jul 01, 2024•1 hr 3 min•Ep. 23
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 [email protected] . Please feel free to send questions, comments and c...
Jun 17, 2024•54 min•Ep. 22
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 [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 wo...
Jun 03, 2024•57 min•Ep. 21
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 [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....
May 20, 2024•1 hr•Ep. 20
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 [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 f...
May 06, 2024•49 min•Ep. 19
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 The...
Apr 22, 2024•1 hr 8 min•Ep. 18
