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 awesome and cute music. Check out their work at https://www.samwinnie.com/

References -

https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/opening-procedures-ema-non-eu-authorities-open-framework

Who Guidance for Best Practice on Clinical Trials - https://iris.who.int/server/api/core/bitstreams/dbe6d97c-b659-4e7b-8070-b4a3c667d6e5/content

https://picscheme.org/en/about

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 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/

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 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/

References

https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices

https://www.fda.gov/medical-devices/regulatory-controls/general-controls-medical-devices

https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/class-ii-special-controls-documents

https://www.fda.gov/media/82395/download

https://www.gov.uk/guidance/medical-devices-how-to-comply-with-the-legal-requirements

https://hollandhoudek.com/implants

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 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/

References

https://www.ncbi.nlm.nih.gov/books/NBK220522/

https://www.cdc.gov/anthrax/prevention/index.html

https://blogs.cdc.gov/niosh-science-blog/2022/04/21/welders-anthrax/

https://www.cnn.com/2024/05/05/us/how-it-really-happened-anthrax-attacks

https://pmc.ncbi.nlm.nih.gov/articles/PMC7993152/

https://journalofethics.ama-assn.org/article/informed-consent-military-anthrax-vaccination-case/2007-10

https://www.fbi.gov/history/famous-cases/amerithrax-or-anthrax-investigation

https://www.sciencedirect.com/science/article/abs/pii/S0264410X22010453

https://pmc.ncbi.nlm.nih.gov/articles/PMC6147967/

https://ajph.aphapublications.org/doi/full/10.2105/AJPH.92.5.715

https://clearinghouse.net/doc/40458/

https://web.archive.org/web/20171114165441/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm474027.htm

https://web.archive.org/web/20171114200815/https://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMRegulatoryScience/ucm391665.htm

https://www.fda.gov/vaccines-blood-biologics/vaccines/biothrax

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 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/

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 Debbie squirm!

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

References -

https://database.ich.org/sites/default/files/Q7%20Guideline.pdf

https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice

https://pmc.ncbi.nlm.nih.gov/articles/PMC7395820/

Maintenance Phase Episode - https://open.spotify.com/episode/2iqRW5kzS02w4HRi6vOi6Q

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 survive the Skull Cave in Stardew Valley, plus so much more.

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/

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!

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

References

https://www.jmir.org/2020/3/e12689/

https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-18#:~:text=A%20patient%2Dreported%20outcome%20(PRO,(Powers%20et%20al%202017).

https://www.gov.uk/guidance/patient-reported-outcomes-and-experiences-study#:~:text=Broadly%2C%20PROMs%20evaluate%20either%20the,pain%20or%20discomfort

https://www.birmingham.ac.uk/research/centres-institutes/patient-reported-outcomes/prolearn/pros-in-trials#:~:text=Capturing%20Patient%2DReported%20Outcomes%20(PROs,and%20treatment%20on%20their%20life.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims