The Evidence Base®’s Post

Welcome to the latest weekly update from The Evidence Base® Explore our daily highlights from all three days of the #ISPEAnnual2024 conference. Read our interview with Ashita Batavia, MD, MS (Johnson & Johnson Innovative Medicine) to learn more about the FDA grant award project ‘Development of Novel Methods to Enable Robust Comparison of Real-World Progression Free Survival (rwPFS) and Clinical Trial PFS in Multiple Myeloma’. I share my Editor’s picks from the September issue of the Journal of Comparative Effectiveness Research, including an Editorial on whether there is a need for an international ISPOR—The Professional Society for Health Economics and Outcomes Research value flower and research assessing the #realworldevidence frameworks provided by #regulatory and #HTA agencies. Check out our Guest Column which explores how researchers can improve patient treatments and outcomes by incorporating #SDOH variables into their work. Don't forget to sign up to our #webinars, including: - Introducing the #ROPAD consortium: unlocking real-world genetic insights to accelerate treatment access for Parkinson’s disease, September 24, 10:30am ET (CENTOGENE) - Incorporating patient centric sampling into multi-center clinical trials: Summary of a PCSIG workshop, October 2, 2024, 11:00AM ET - Replacing serum with dried blood microsampling for pediatric pharmacokinetics of prophylactic RSV monoclonal antibody, September 25, 2024, 11:00am ET Plus, #RWE and #RWD news from NICE - National Institute for Health and Care Excellence, OMNY Health and the NHS

OMNY Health has announced the launch of a new GLP-1 data network that integrates real-world data (#RWD) from electronic health record (EHR) data of >645,000 patients. Read more at The Evidence Base® https://lnkd.in/efRChEWP #RealWorldData #GLP1 #HealthData #RealWorldDataNetwork #RWE #RealWorldEvidence

That's a wrap on #ISPEAnnual2024! It's been a great event, bringing together experts from around the globe to discuss key issues in pharmacoepidemiology, real-world evidence, and the mission of the International Society for Pharmacoepidemiology to advance the health of the public.   The final day included a packed schedule, including talks on social determinants of health and the problem of confounding (and how best to tackle it!).   📖 Read our recap of some of the sessions from Day 3 here https://lnkd.in/gKR4HH6a   #AI #ISPE #Pharmacoepidemiology

As part of its #RealWorldEvidence efforts, the FDA announced four new Cooperative Agreement awards in 2023 to explore the use of #RealWorldData for regulatory decision-making. These demonstration projects aim to broaden the FDA’s understanding of #RWD and #RWE in drug approval and post-approval studies and encourage innovative approaches to support the use of RWE while ensuring that scientific evidence meets the agency’s standards.   In this interview, we speak with Ashita Batavia, MD, MS (Johnson & Johnson Innovative Medicine) to learn more about the project ‘Development of Novel Methods to Enable Robust Comparison of Real-World Progression Free Survival (rwPFS) and Clinical Trial PFS in Multiple Myeloma’.   #HealthData #MultipleMyeloma #Myeloma #ProgressionFreeSurvival   Read at The Evidence Base®: https://lnkd.in/eg_jBCgH 

It’s the final day of the International Society for Pharmacoepidemiology Annual Conference, but there’s still lots to look forward to… Recaps of days 1 and 2 are on The Evidence Base now, and be sure to check back soon for Day 3! #ISPEAnnual2024 #ISPE #pharmacoepidemiology

Day 2 of the International Society for Pharmacoepidemiology Annual Meeting 2024 was another jam-packed program of content, which today included a plenary session on perinatal pharmacoepidemiology, a symposium session on implementation science, and, of course, the Annual Awards! 🏆 📖 Read our recap of some of the sessions from Day 2 here https://lnkd.in/e2pM8p9J   #ISPEAnnual2024 #ISPE #Pharmacoepidemiology

Check out our Editor Laura Dormer's picks from the latest issue of the Journal of Comparative Effectiveness Research, including an Editorial on whether there is a need for an international #ISPOR value flower; a Plain Language Summary of Publication article on treatment for narcolepsy type 1 and type 2; and research conducting an environment scan of real-world evidence frameworks. LCP, University of Montpellier, Cytel, Takeda #OpenAccess #PlainLanguage #PLSP #HEOR #RWE https://lnkd.in/ef2UVfv6

Day 2 is underway at #ISPEAnnual2024! Our recap of Day 1 is available now on The Evidence Base, and be sure and check back later to read our highlights of Day 2. #ISPE #Epidemiology International Society for Pharmacoepidemiology

Day 1 of #ISPEAnnual2024 is now complete! The Evidence Base editor Laura Dormer had a great start to the International Society for Pharmacoepidemiology Annual Meeting in Berlin, with some particular highlights including the opening Keynote Plenary session on person-generated health data and artificial intelligence, a presentation from German Minster for Health Dr Karl Lauterbach on new health data laws, and more!   📖 Read our recap of some of the sessions from Day 1 here https://lnkd.in/evrGgAFF   #AI #ISPE #Pharmacoepidemiology

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved #lecanemab, the first drug designed to slow the progression of early-stage #AlzheimersDisease. However, NICE - National Institute for Health and Care Excellence has decided against making it available through NHS England. Read more on The Evidence Base >>> https://lnkd.in/emhizMjq