The RWD & RWE Podcast

Ep 159 [18 December 2024]: Joseph Beals PhD MBA FAMIA and Kathy Belk – Clarity in Data: Getting from P-Values to Practice in RWE

Ep 159 [18 December 2024]: Joseph Beals PhD MBA FAMIA, CEO and Kathy Belk, COO at Health Clarity Solutions – We discussed overcoming many of the challenges associated with the use of RWD for RWE, specificially focusing on the Accuracy, Clarity & Value framework for anticipating and assessing risk to the RWE program.Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 158 [11 December 2024]: Gary Schneider MSPH ScD – Preventing RWE’s (Real-World Errors) in Real-World Research!

Ep 158 [11 December 2024]: Gary Schneider, MSPH, ScD, founder of Delve-RW LLC – We discussed his learnings from his organizations’ niche offering of conducting independent review of Statistical Analysis Plans (SAPs) for Pharma sponsored, regulatory agency committed, observational, non-interventional studies. Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 157 [04 December 2024]: November experiences at CNS Summit / DTRA / ISPOR EU 2024

Ep 157 [04 December 2024]: Expriences at CNS Summit / DTRA / ISPOR EU 2024! With distinguished co-host, David Thompson and other live participants to Real-World Wednesdays, we attended CNS Summit / DTRA / ISPOR EU 2024 this year, and discussed things we saw/heard/learned.Disclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 156 [06 November 2024]: Viraj Narayanan MBA – Access to Enablement: The evolving world of RWD

Ep 156 [06 November 2024]: Viraj Narayanan MBA, CEO at Cornerstone AI – We discussed what Decision Science is and why it provides an important foundation to how Viraj considers solutions to challenges in the RWD/RWE field. We also discussed why Viraj is focused on rapid and comprehensive data assessments as well as steps to improve the underlying quality of RWD; data optimized for use -- is critical for efficient RWE generation and machine learning models can generate unique, clinically relevant data cleaning rules for every dataset more more effectively than traditional methods leveraged by technical teams.Please check-out our website to join the club, get updates and see podcast recordings: https://rwd-rwe.clubDisclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 155 [30 October 2024]: John Shon MD MS – RWD in a decentralized observational COVID biomarker study

Ep 155 [30 October 2024]: John Shon MD MS, Chief Technology Officer at SerImmune Inc. – We discussed leveraging highly multiplex serology assays to study SARS-CoV-2 antibody dynamics in individuals in response to vaccines and infections informing the study insights with RWD.Please check-out our website to join the club, get updates and see podcast recordings: https://rwd-rwe.clubDisclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 154 [23 October 2024]: Tom Kaminski MBA – Converting real-world data into ENROLLED patients

Ep 154 [23 October 2024]: Tom Kaminski MBA, CEO of Clinetic (former SVP Strategy for Labcorp) – We discussed the last mile of patient engagement, leading to enrollment and leveraging health-system based RWD to accelerate research trials and RWE.Please check-out our website to join the club, get updates and see podcast recordings: https://rwd-rwe.clubDisclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 153 [16 October 2024]: Liisa Palmer PhD – Ep 153: Finding balance with RWD

Ep 153 [16 October 2024]: Liisa Palmer PhD, Portfolio Leader, Real-Word Data Research & Analytics at @Merative (Truven MarketScan) – We discussed important considerations around “fit-for-purpose” data in a rapidly expanding ecosystem, especially as researchers have more choice in RWD than ever before!Please check-out our website to join the club, get updates and see podcast recordings: https://rwd-rwe.clubDisclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

[10 October 2024] Special Crossover Episode from TGIF-DTRA + Real World Wednesday: The Venn Diagram of Point of Care Trials, DCTs, and RWD

[10 October 2024] Special Crossover Episode from TGIF-DTRA + Real World Wednesday: The Venn Diagram of Point of Care Trials, DCTs, and RWD.With the release of the FDA Draft Guidance on Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice, it was the perfect topic to bring together the DCT and RWE community for a conversation around this guidance.We discussed why this guidance was aligned to RWE, the distinctions between decentralized, pragmatic, point-of-care trials, and real-world evidence, and how RCTs and DCTs can drive access for all patients.Read the guidance here --> https://www.fda.gov/regulatory-information/search-fda-guidance-documents/integrating-randomized-controlled-trials-drug-and-biological-products-routine-clinical-practicePlease check-out our website to join the club, get updates and see podcast recordings --> https://rwd-rwe.clubDisclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 152 [09 October 2024]: Tom Haskell – Specialty EMR = Specialized RWD/RWE

Ep 152 [09 October 2024]: Tom Haskell, General Manager, Real-World Data at Modernizing Medicine (ModMed) – We discussed the optimization of RWE through the use of medical specialty-aligned EHRs. Indication-specific outcomes are enhanced by EHRs developed to support the unique attributes or measures of the medical specialty itself, ensuring relevant data are included in the RWD, accelerating RWE research.Please check-out our website to join the club, get updates and see podcast recordings: https://rwd-rwe.clubDisclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.

Ep 151 [02 October 2024]: Doug Fridsma MD PhD – AI in EHR RWD - important regulatory changes coming soon!

Ep 151 [02 October 2024]: Doug Fridsma MD PhD, Chief Medical Informatics Officer (CMIO) at Health Universe – Former CMIO at Datavant, Former President and CEO at the American Medical Informatics Association (AMIA), and Former Chief Science Officer at the Office of the National Coordinator for Health IT (ONC/HHS) – We discussed regulatory changes in the EHR decision support arena.He provided an overview policy changes and delve into the relevance of these changes for the RWD/RWE market, specifically focusing on the new ONC, 45 CFR § 170.315(b)(11) Decision Support Interventions (DSI) Criterion, a set of updated rules for health IT systems that go into effect by January 1, 2025. These changes aim to make health IT systems more interactive and data-driven, ultimately helping healthcare providers and researchers alike.https://www.healthit.gov/test-method/decision-support-interventionsONC/HHS (b)(11) primer: https://www.healthit.gov/sites/default/files/2024-07/DSI_Explainer_9_Key_Functionalities_DSI_Criterion_508.pdfPlease check-out our website to join the club, get updates and see podcast recordings: https://rwd-rwe.clubDisclaimer: The views expressed in this podcast are the guest's and host's alone, and do not reflect the official position of any organization or entity with whom they are, or have been, professionally affiliated.