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By Kim Kristiansen & JG Staal
The podcast currently has 13 episodes available.
Clinical Trials & Surrogate Outcomes
Looking for clinical relevance means looking for a lot of details.
A crucial part of that is looking at WHAT is compared with WHAT
But what if a comparison is not clinically relevant - what do you do then?
And how about studies using surrogate outcomes perhaps even approved by the FDA - they must be clinically relevant - but are they?
In this episode, we talk about how to navigate this and find the best available research
You don’t want to miss this episode
Get the Precision Evidence Newsletter https://bit.ly/3tLBx3Z
LINKS:
Assessment of Overall Survival, Quality of Life, and Safety Benefits Associated With New Cancer Medicines Supplemental content, JAMA Oncology (2017) https://jamanetwork.com/journals/jamaoncology/fullarticle/2594542
FDA Approved Surrogate Endpoints: https://www.fda.gov/drugs/development-resources/table-surrogate-endpoints-were-basis-drug-approval-or-licensure
Virtual Reality Smartphone-Based Intervention for Smoking Cessation: Pilot Randomized Controlled Trial on Initial Clinical Efficacy and Adherence https://www.jmir.org/2020/7/e17571/
NOTES:
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 to 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
Contact us at email: [email protected],
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 & https://www.linkedin.com/in/kim-kristiansen
JG Staal: @HealthyEvidence
Music thanks to mixkit.co
Addressing Clinical Relevance in Medical Papers
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
We want to make it mandatory to state the researchers' clinical relevance levels ahead of the trial, mentioning what they will consider clinically relevant when they pre-register their research on the clinicaltrials.gov website or similar websites. They then need to compare their findings in both the paper and abstract when publishing data from the study. #clinicalrelevance
LINKS:
Once-Weekly Semaglutide in Adults with Overweight or Obesity Paper https://www.nejm.org/doi/full/10.1056/NEJMoa2032183ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/study/NCT03548935
10-Year Update on Study Results Submitted to ClinicalTrials.gov
https://www.nejm.org/doi/full/10.1056/NEJMsr1907644
FDA and NIH let clinical trial sponsors keep results secret and break the law https://www.sciencemag.org/news/2020/01/fda-and-nih-let-clinical-trial-sponsors-keep-results-secret-and-break-lawCompliance with the legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(19)33220-9.pdf
Our specific page on our website about requesting clinical relevance statement and evaluation https://www.precision-evidence.com/p/clinical-relevance/
Overview of clinical trials registers like clinicaltrials.gov: https://sites.google.com/a/york.ac.uk/yhectrialsregisters/home/clinicaltrials
Precision Evidence episode 11: “Clinical relevance - Looking at Recent Papers” https://www.precision-evidence.com/11
NOTES:
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 to 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
Contact us at email: [email protected],
Twitter @PrecisionEBM,
You can learn more at our website, where you can also leave us a voice message.
Website: www.precision-evidence.com
Get the Precision Evidence Newsletter https://bit.ly/3tLBx3Z
Hosts:
Dr. Kim Kristiansen, M.D: @KKristiansenMD & https://www.linkedin.com/in/kim-kristiansen
JG Staal: @HealthyEvidence
Music thanks to mixkit.co
Clinical trials and research should always aim to provide information that is meaningful and relevant for patients.
We want to make it mandatory to state the researchers' clinical relevance levels ahead of the trial, mentioning what they will consider clinically relevant when they pre-register their research on the clinicaltrials.gov website or similar websites. They then need to compare their findings in both the paper and abstract when publishing data from the study. #clinicalrelevance
LINKS:
Our specific page on our website about requesting clinical relevance statement and evaluation https://www.precision-evidence.com/p/clinical-relevance/
Overview of clinical trials registers like clinicaltrials.gov: https://sites.google.com/a/york.ac.uk/yhectrialsregisters/home/clinicaltrials
Precision Evidence episode 10: “How to Get to Clinically Relevant Research” https://www.precision-evidence.com/10
NOTES:
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 to 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
Contact us at email: [email protected],
Twitter @PrecisionEBM,
You can learn more at our website, where you can also leave us a voice message.
Website: www.precision-evidence.com
Get the Precision Evidence Newsletter https://bit.ly/3tLBx3Z
Hosts:
Dr. Kim Kristiansen, M.D: @KKristiansenMD
JG Staal: @HealthyEvidence
Music thanks to mixkit.co
How to Get to Clinically Relevant Research
The default method to evaluate clinical research is by statistical significance
Unfortunately is statistical significance not related to the meaningfulness of the findings in the research and thereby to its meaningfulness for patients and healthcare
If researchers stated ahead of starting the trial what they would consider clinically relevant, the reader could relate to that and agree or disagree with the researcher
It would come from focusing on using the provided information to help patients and improve healthcare - and not just publishing a paper
We want to make it mandatory to state the researchers' clinical relevance levels ahead of the trial, mentioning what they will consider clinically relevant when they pre-register their research on the clinicaltrials.gov website or similar websites. They then need to compare their findings in both the paper and abstract when publishing data from the study. #clinicalrelevance
LINKS:
A specific page on our website about requesting clinical relevance statement and evaluation https://www.precision-evidence.com/p/clinical-relevance/
The history behind the chosen level for statistical significance with Ronald Fisher's book from 1925 "Statistical Methods for Research Workers." Precision Evidence Blog: https://www.precision-evidence.com/blog/the-p-value-and-sir-ronald-fischer/
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
Only 15% of clinical research brings value: “Avoidable waste in the production and reporting of research evidence” https://pubmed.ncbi.nlm.nih.gov/19525005/Precision Evidence #8: "Critical Appraisal of the Moderna COVID19 Vaccine Trial"
https://www.precision-evidence.com/8
Precision Evidence #6: "Covid-19 Vaccines Trials: Understanding the First Published Results" https://www.precision-evidence.com/6
Precision Evidence #5: "Covid-19 Vaccines Trials and Press Releases – Looking Beyond the Efficacy" https://www.precision-evidence.com/5
TED talk with Sir Ken Robinson where he talks about two kinds of people https://www.ted.com/talks/sir_ken_robinson_bring_on_the_learning_revolution
NOTES:
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
Contact us at email: [email protected],
Twitter @PrecisionEBM,
You can learn more at our website, where you can also leave us a voice message
Website: www.precision-evidence.com
Get the Precision Evidence Newsletter https://bit.ly/3tLBx3Z
Hosts:
Dr. Kim Kristiansen, M.D: @KKristiansenMD
JG Staal: @HealthyEvidence
Music thanks to mixkit.co
Russia's Sputnik COVID19 Vaccine Trial - Efficacy and Limitations
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:
The Sputnik COVID19 Vaccine trial in the Lancet https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00234-8/fulltext
Precision Evidence #8: “Critical Appraisal of the Moderna COVID19 Vaccine Trial”
https://www.precision-evidence.com/8
Precision Evidence #6: “Covid-19 Vaccines Trials: Understanding the First Published Results”
https://www.precision-evidence.com/6
Precision Evidence #5: “Covid-19 Vaccines Trials and Press Releases – Looking Beyond the Efficacy”
https://www.precision-evidence.com/5
NOTES:
Contact us at email: [email protected],
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
Music thanks to mixkit.co
Critical Appraisal of the Moderna COVID19 Vaccine Trial
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:
Contact us at email: [email protected],
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
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:
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
Covid-19 Vaccines Trials: Understanding the First Published Results #6
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 https://www.precision-evidence.com/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:
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
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 https://www.precision-evidence.com/tool
LINKS:
Table with estimates of how many people need to be vaccinated to prevent one case of covid-19 https://www.precision-evidence.com/blog/how-many-people-need-to-be-vaccinated-to-prevent-one-case-of-covid-19/
Precision Evidence Matrix https://precision-evidence.com/matrix
NOTES:
We only have limited information about the new Covid-19 vaccines released by press releases
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
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 https://www.precision-evidence.com/tool
LINKS:
Covid-19 and face mask study https://www.acpjournals.org/doi/10.7326/M20-6817
CDC Guidelines https://www.cdc.gov/coronavirus/2019-ncov/more/masking-science-sars-cov2.html
Precision Evidence Podcast Episode #2 http://www.precision-evidence.com/2
NOTES:
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
The podcast currently has 13 episodes available.