Intro to Clinical Research

Episode 60   In this episode, we’re back in Elyse’s corner (hooray!), and today, we’re talking about the interstitium (with a prelude into the human lymphatic system). Don’t worry if you have no clue what either of those things are, we’re doing a basic guide today but check out the references for much more info! Remember, you can get in touch with us via clinical.research.intro@gmail.com . Please...

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 quest...

Today, we’re finally getting into why Debbie says “it depends” so much in answer to many of Elyse’s questions. We’re looking at how ICH GCP sets out the principles and practices that should be followed to have harmonised, quality research. This is part 1, so stay tuned for part 2 following soon!  Remember, you can get in touch with us via clinical.research.intro@gmail.com . Please feel free to sen...

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.  Rememb...

In this episode, we’re going to be discussing some international collaborations in clinical research! Let’s cross some borders and work together! 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 awesom...

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...

Hey everyone! We’re back and we hope you didn’t miss us too much. In this episode, we’re diving right back in and talking about Medical Devices - what they are, how varied they can be, and how they’re regulated (in general terms!)  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...

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 an...

In this episode, we’re talking about Data Management because of a listener question - thanks very much Aswini! So, we get into the weeds about the data that is collected as part of a clinical trial and what is done with it - including what “data cleaning” really is! Remember, you can get in touch with us via clinical.research.intro@gmail.com . Please feel free to send questions, comments and compl...

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 Deb...

Wow, 50 episodes of our podcast. How exciting. So, in celebration, I’ve collected together some out-takes and previously un-released material (un-released, in that, we recorded it and I edited it out of the main episode, often for a good reason!) So you have a real mixed bag selection of Debbie stumbling over words, lots of laughter, reading emails out loud to Elyse, and us talking about how to su...

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! C...

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...

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...

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 clinical.research.intro@gmail.com . Please feel free to send questions, comments and compliments for Elyse to read out on the pod. It...

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.resea...

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 t...

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 re...

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...

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 r...

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...

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 . Plea...

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 compli...

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 t...

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 com...