Clinical trials and research should always aim to provide information that is meaningful and relevant for patients. In the last episode, we looked at how many - or rather - how few researchers mentioned and argued for what they would see as clinically relevant outcomes when setting up a study and listing it on clinicaltrials.gov In this episode, we go deeper to look at examples and why this is so important to improve the usefulness of the research

Clinical trials and research should always aim to provide information that is meaningful and relevant for patients. However, researchers are rarely addressing that topic when presenting results from trials. In this episode, we look at published papers from high-ranking journals to get a sense of the extent of that problem.  You may be surprised by our findings...

Discussing the statistical and clinical significance in clinical research and the big improvements for patients and healthcare if researchers stated ahead of starting the trial what they would consider clinically relevant. It would come from focusing on using the provided information to help patients and improve healthcare - and not just publishing a paper

The interim analysis of the Russian Sputnik COVID19 vaccine is published in The Lancet It demonstrates efficacy at 94.6% which is comparable to the Pfizer/BioNTech and Moderna vaccine interim analysis Safety is comparable as well There are, however,  when scrutinizing the study, some serious concerns with impact on the usefulness of the vaccine and reducing 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

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 nee

Analyzing the details of the Pfizer/BioNTech and AstraZeneca COVID19 Vaccine trials. What do the efficacy measures mean and how many persons must be vaccinated to prevent one COVID19 infection? We also look at what an mRNA vaccine is and what to expect from future studies

We still need much more information from the Covid-19 vaccine trials than published in the press releases to be able to have a clear picture of the efficacy and safety of the Covid-19 vaccines, let alone the precision and clinical relevance of the findings. In this episode, we analyze what we know so far. The information presented in the press releases are not sufficient to make calculations on risk But here is what you can find if you do it anyway

The world's currently largest randomized controlled trial (RCT) on Covid-19 protection by face masks is just published. The study showed a reduction in risk for Covid19 by using a facial mask  There are, however, severe limitations in this study and much more to mask-wearing than provided by this study, In this episode, we go beyond the abstract for the details.

In the Covid-19 vaccine trials, there is an essential difference between the relative reduction of risk for covid19 provided by vaccination and the absolute risk reduction for the individual person. But can we expect to find that information in the papers referring the trials - and will we be able to compare results between the different vaccines? Furthermore, must the study population in the vaccine trials reflect those expected to benefit from vaccination. And that seems to be a problem too. In this episode, we are looking at what kind of relevant information we need from the upcoming Covid-19 vaccine trials - and how you can get that information     Links:  FDA guidance https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders JAMA Internernal Medicine, Older People: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2771091 Vaccine Efficacy Needed for a COVID-19 Coronavirus Vaccine to Prevent or Stop an Epidemic as the Sole Interventionhttps://www.ajpmonline.org/article/S0749-3797(20)30284-1/fulltext#:~:text=This%20study%20found%20that%20the,(e.g.%2C%20social%20distancing)   Notes: We will get the most valuable information from well designed clinical trials proving high protection for Covid-19 and high safety for those vaccinated based on analysis from a broad study population FDA requires in their guideline and recommendation at least 50% protection That is a relative risk reduction of 50%, but how does that translate into the absolute risk Computational models have calculated the need for higher protection How about precision in terms of study population and usefulness of data Why the comparison between different studies is not possible, and how you can get around that   We will review published Covid-19 vaccine trials here at the Precision Evidence Podcast, so be sure to subscribe and share with friends!     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