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/NEJMoa2032183 ClinicalTrials.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-law Compliance 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: Why is stating levels for clinical relevance important to make before a clinical trial starts?How should authors of clinical research papers refer and compare to clinical relevance statements?Looking at a specific study Importance of also looking at how the study is doneIn/exclusion criteriaCompliance with listing on clinicaltrials.govCompliance with publishing results on clinicaltrials.govChallenges to make a comprehensive review and analysis of a medical paper to make sure the information is both trustworthy and clinically relevant 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: 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 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
