Critical Appraisal of the Moderna COVID19 Vaccine Trial

• There is a big interest in clinical research now due to the Covid19 pandemic
• Especially the trails behind the Covid vaccines gain interest and is all over the news
• In this episode, we take a look at the published paper on the Moderna vaccine trial using our last episode of this podcast (#7) about the precision of the evidence
• We know from the news that the outcome in the Moderna vaccine trial is good with a reduction in risk at 94.1% by getting the vaccine
• But is the study as a whole clinically relevant and trustworthy?
• And how many people need to be given the vaccination to prevent one COVID19 infection? - Probably not what you would guess
• We will cover this and much more in this episode

GET THE ABSTRACT SCREENING TOOL

It can be a challenge to screen papers for clinical relevance. As we go beyond the abstract in this podcast, we have created a screening tool you can use when reading an abstract from a clinical research paper.

Using that tool enables you to quickly screen an abstract from a medical journal for clinical relevance selecting only those you want to read. At the same time, you will know why you skipped the rest. Get it at our website https://www.precision-evidence.com

LINKS:

Moderna vaccine trial interim analysis paper (full access) https://www.nejm.org/doi/full/10.1056/NEJMoa2035389

Moderna vaccine trial interim analysis on clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT04470427

Evaluating clinical relevance in 2 x 2 matrix https://www.precision-evidence.com/matrix

Precision Evidence #7 https://www.precision-evidence.com/7

Precision Evidence #6 https://www.precision-evidence.com/6

Precision Evidence #5 https://www.precision-evidence.com/5

NOTES:

• Moderna vaccine trial has a somewhat confusing abstract
• Efficacy is high at 94.1% - and what that means in real life
• It is statistically significant, but is it also clinically significant and relevant?
• Stating what to be regarded clinically significant BEFORE stating the trial is important!
• A closer look at study population and dropouts
• A closer look at randomization and study period
• The study on clinicaltrials.gov compared with paper, what can we learn?
• How many persons need to be given the vaccination to prevent one COVID19 infection? - Probably not what you would guess
• Safety and other vaccines
• What we still need to know
• Phase 3 vs Phase 4 trials
• Conclusion
• Future episodes of the Precision Evidence Podcast

Contact us at email: podcast@precision-evidence.com,

Twitter @PrecisionEBM,

You can learn more at our website, where you can also leave us a voice message

Website: www.precision-evidence.com

Hosts:

Dr. Kim Kristiansen, M.D: @KKristiansenMD

JG Staal: @HealthyEvidence

PRECISION EVIDENCE ON TOP LIST

Precision Evidence has been selected by Feedspot to the list of

Top 35 Clinical Trials Podcasts You Must Follow in 2021

https://blog.feedspot.com/clinical_trials_podcasts/

Music thanks to mixkit.co