Intro to Clinical Research

Episode 19 - Informed Consent

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 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/

Episode 18 - Issues with Treatments

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 Therapy Update » Sickle Cell Society
Montelukast (Singulair): reminder of the risk of neuropsychiatric reactions - GOV.UK (www.gov.uk)
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/

Episode 17 - Elyse's Corner: CPR

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 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/

Episode 16 - Study End-to-End

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, 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/

Episode 15 - Good Documentation Practice (GDP)

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-criminal-investigations/warning-letters/amazoncom-inc-662503-12202023 
AND! Debbie finally found the name of the drug that began with a “K” = Ketek, and the fraudulent enrollment https://www.nejm.org/doi/full/10.1056/NEJMp078032#:~:text=The%20study%20was%20completed%20in,complete%20fabrication%20of%20patient%20enrollment.
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/

Episode 14 - Quality Assurance

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, 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/

Episode 13 - Questions and Answers

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 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/

Episode 12 - Phenylephrine

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 interested, since this episode was recorded a few weeks ago compared to when it is being released - https://www.fda.gov/drugs/drug-safety-and-availability/fda-clarifies-results-recent-advisory-committee-meeting-oral-phenylephrine
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/

Episode 11 - Elyse’s Corner: Ketamine Therapy

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 caution. 
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/

Episode 10 - Historical Stuff part 2

In this episode, Debbie is going to continue to tell Elyse about some tragedies in clinical trials, what occurred, what we learned and the consequences of them. This is part two of two linked episodes (this and the previous episode). 
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’t sound like something you want to listen to, feel free to give this one a miss. 
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/