Intro to Clinical Research

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. I...

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...

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...

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...

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-lette...

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 ...

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...

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 r...

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 ...

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 (raci...

In this episode, Debbie is going to tell Elyse about some tragedies in clinical trials, what occurred, what we learned and the consequences of them. This is part one of two linked episodes (this and the next 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) -...

In this episode, Debbie is going to tell Elyse about documentation and how important it is as both the instructions of how to do the study and evidence of what/ how it was actually done. Making sure that everything is documented is an important part of transparency. We hope you enjoy us nerding out about paperwork! 

You can get in touch with us via clinical.research.intro@gmail.com. Please feel free to send questions, comments and ...

Ever wondered how new medicines become available at your Pharmacy or through your Doctor? Clinical Research is key to making this happen! In this episode, Debbie is going to tell Elyse about research study design, so we’re going to learn how it works to build a study from the ground up to meet their goal?

You can get in touch with us via clinical.research.intro@gmail.com

Credit to our friend Sam Winnie for their awesome and cute mu...

Ever wondered how new medicines become available at your Pharmacy or through your Doctor? Clinical Research is key to making this happen! In this episode, we’re talking about the rules, regulations and guidance in place to ensure research is done properly. 

You can get in touch with us via clinical.research.intro@gmail.com

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinni...

Ever wondered how new medicines become available at your Pharmacy or through your Doctor? Clinical Research is key to making this happen! In this episode, Elyse grabs the wheel and drives us (including Debbie!) through what Narcan is, and how it’s saving lives. 

You can get in touch with us via clinical.research.intro@gmail.com

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.sam...

Ever wondered how new medicines become available at your Pharmacy or through your Doctor? Clinical Research is key to making this happen! In this episode, Debbie and Elyse explore the question, "How come some medicines get to jump the queue, and get approved through that accelerated approval program?"

You can get in touch with us via clinical.research.intro@gmail.com

Credit to our friend Sam Winnie for their awesome and cute music....

Ever wondered how new medicines become available at your Pharmacy or through your Doctor? Clinical Research is key to making this happen! In this episode, Debbie and Elyse explore the question, "what are the parts of the process and who is involved?"

You can get in touch with us via clinical.research.intro@gmail.com

Credit to our friend Sam Winnie for their awesome and cute music. Check out their work at https://www.samwinnie.com/