The Precision of Clinical Research #7

01/15/21 • 19 min

You’ve probably often heard that “Clinical trials show..” or “ evidence support that..”
Unfortunately, a research paper being published in a peer-reviewed medical journal is NOT a guarantee that it is clinically relevant - even if it is a high ranking journal
As it is often the case the devil is in the details, so it is necessary to both read and evaluate the paper’s details and to put it into the context where you need the information
In this episode, we will talk about the details you need to look for

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:

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

96% of published studies mention a p-value at 0.05 or lower: “What Have We (Not) Learned from Millions of Scientific Papers with P Values?” https://www.tandfonline.com/doi/full/10.1080/00031305.2018.1447512

Overview of clinical trials registers like clinicaltrials.gov: https://sites.google.com/a/york.ac.uk/yhectrialsregisters/home/clinicaltrials

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/

NOTES:

The conclusion in a clinical research paper is based on an analysis of data collected from a specific group of people: the study population
We have developed helpful tools to guide and help you with the process of screening afnf evaluate a paper from a clinical trial
- The Abstract Screening Tool
- The Precision Evidence Matrix for Clinical Relevance
- Links to both above
The clinical usefulness depends on inclusion and exclusion criteria as well as the study design and method
The relevance of inclusion and exclusion
Can results be extrapolated to persons not included in a specific clinical trial?
What are the relevant outcomes?

You’ve probably often heard that “Clinical trials show..” or “ evidence support that..”
Unfortunately, a research paper being published in a peer-reviewed medical journal is NOT a guarantee that it is clinically relevant - even if it is a high ranking journal
As it is often the case the devil is in the details, so it is necessary to both read and evaluate the paper’s details and to put it into the context where you need the information
In this episode, we will talk about the details you need to look for

GET THE ABSTRACT SCREENING TOOL

LINKS:

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

Overview of clinical trials registers like clinicaltrials.gov: https://sites.google.com/a/york.ac.uk/yhectrialsregisters/home/clinicaltrials

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/

NOTES:

The conclusion in a clinical research paper is based on an analysis of data collected from a specific group of people: the study population
We have developed helpful tools to guide and help you with the process of screening afnf evaluate a paper from a clinical trial
- The Abstract Screening Tool
- The Precision Evidence Matrix for Clinical Relevance
- Links to both above
The clinical usefulness depends on inclusion and exclusion criteria as well as the study design and method
The relevance of inclusion and exclusion
Can results be extrapolated to persons not included in a specific clinical trial?
What are the relevant outcomes?

Previous Episode

Covid-19 Vaccines Trials: Understanding the First Published Results #6

Covid-19 Vaccines Trials: Understanding the First Published Results #6

With massive awareness in the media, we now have some detailed information about the first of the Covid19 vaccine trials
They differ in clinical usefulness
The efficacy measures of 95% are widely mentioned, but let's be clear about what it means and how can we use that information
In this episode, we go beyond the news coverage to find out and calculate how many persons need to be vaccinated to prevent one Covid19 infection both in general and for subgroups

GET THE ABSTRACT SCREENING TOOL

LINKS:

Pfizer/BioNTech data from FDA https://www.fda.gov/media/144245/download

Pfizer/BioNTech paper in NEJM https://www.nejm.org/doi/full/10.1056/NEJMoa2034577?query=featured_home

AstraZeneca Paper in the Lancet https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext

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

Table with estimates of how many people need to be vaccinated to prevent one case of covid-19 https://www.precision-evidence.com/blog/covid19-and-the-first-clinical-trials-analyzing-the-details/

NOTES:

In this episode, we follow up on the last episode of the Precision Evidence Podcast where we went beyond the press releases about the Covid19 vaccines
Now we have data from the first trials The Pfizer/BioNTech trial and the AstraZeneca Trial
They are different in many ways
How valid and useful is the data?
The meaning and clinical relevance of efficacy at 95%
How about clinical relevance and precision of the evidence
To find out, we calculate how many persons must get a vaccination to prevent one Covid19 infection, both in general and for age and comorbidity subgroups
Number Needed to Treat (NNT), or instead, Number Needed to Vaccinate
Safety of the vaccines
What is an mRNA vaccine
What do we still not know / and does it matter?
Conclusion and what to expect from other vaccine trials

Contact us at email: [email protected],

Twitter @PrecisionEBM,

website: www.precision-evidence.com

Hosts:

Dr. Kim Kristiansen, M.D: @KKristiansenMD

JG Staal: @HealthyEvidence

Music thanks to mixkit.co

Next Episode

Critical Appraisal of the Moderna COVID19 Vaccine Trial #8

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

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