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 :) ...

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 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 Sa...

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...

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 f...

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 tou...

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 wi...

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 clinical.research.intro@gmail.com . Please feel fr...

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! Cred...

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@g...

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, drawi...

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 no...

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 a...

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 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 mak...

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 touc...

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...

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 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...

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...

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...

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 f...

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, commen...

So 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-cr...

How do we ensure (and assure) the quality of every part of the clinical trial process. Why do you even need quality assurance? What sorts of things do auditors or Inspectors find? That’s our topic for today’s episode, so be prepared to hear about what QA is and why it’s important.  Remember, you can get in touch with us via clinical.research.intro@gmail.com . Please feel free to send questions, co...

Unlucky for some, but for us we’re delighted - Episode 13 is our long awaited 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...

In this episode, Debbie explains to Elyse all about phenylephrine and why it’s been in the news (and maybe not as obvious on your pharmacy shelves) in the last 6 months. What research was done when to get this drug onto the market, what the FDA have said recently and what may the next steps be going forwards.  We recommend you check out the FDA website to stay up to date on this issue, if you’re i...

Ep 11 In this episode, we’re back in Elyse’s corner, and it’s lovely! Elyse is going to tell Debbie all about Ketamine therapy and how it’s being researched as a potential treatment for major depressive disorder. A content warning for this episode - consider whether this episode is right for you to listen to, as there is discussion on mental health, depression and suicide. Please proceed with caut...