Real-world evidence (RWE)-based approaches will increasingly influence clinical decision-making as real-world data (RWD) analysis methods advance, along with expanding acquisition, aggregation, and harmonization of RWD from traditional and novel sources. Growth of real-world datasets will elevate statistical power and generalizability, and ultimately is expected to enhance disease prevention and management across clinical domains and populations. However, this progress will require that the precision medicine community ensures that RWD are unbiased and drawn from diverse populations. Indeed, realizing the promise of precision medicine will depend upon empowering RWD to identify and address health disparities.
RWE – the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD – has already been included in various approval procedures of regulatory authorities, yet RWE research is still in a transition process. Since several gaps in this field are still being explored, more guidance and definitions are necessary to increase the implementation of RWE applications.
The field of RWE applications is diverse, and its impact is expected to include speeding up approval processes for therapies and vaccine research and development as has been shown during the COVID-19 pandemic. In this context, RWD is being collected to monitor vaccine uptake, safety, and efficacy, particularly among vulnerable populations. On the clinical side, artificial intelligence (AI) driven by RWD has been beneficial for clinical risk screening.
“To expedite RWE applications the community should make raw data and code to analyze RWD accessible, develop, and disseminate advance methods to collect and apply RWD, and participate in government programs, such as the FDA’s Advancing Real-World Evidence Program, and take measures to avoid, detect, and address bias (e.g., by using the Algorithmic Bias Playbook).”
Dr. Ben Rubin, Associate Director, Precision Medicine, UCSF & PMWC Jan. 25-27, 2023 Real World Evidence Track co-chair (Program)
Considering these facts and the importance of RWE and RWD in becoming instrumental for drug discovery and health care decision making, we have designed a full one-day track (Track 2 Day 2) focusing on Real World Evidence during PMWC 2023 SV, which is co-chaired by Courtney McFall and Ben Rubin (both at UCSF, Precision Medicine, Office of the Vice Chancellor of Science Policy & Strategy). The focus will be on important critical aspects of developing RWE applications, integrating RWE and RWD to support drug development, clinical studies using RWD (real-world data), and methodologies and challenges in the construction and application of real-world databases.
Come join us today at the Real-World Evidence / Data Track at PMWC 2023 Silicon Valley, January 25-27. Highlights of the track include:
• Clinical Studies Using RWD – a panel chaired by Aaron Kamauu (Navidence) with Liora Schultz (Stanford University), Sanket Dhurva (UCSF), Scott Morris (Optum Life Sciences), Motiur Rahman (FDA), and Atul Butte (UCSF)
• Beyond the EHR: Acquisition of RWD Types to Enable Precision Medicine – a panel chaired by Riley Bove (UCSF) with Anna Berry (Sypase), Ashley Brenton (Optum Life Sciences), and Vasu Chandrasekaran (Ontada)
• Data Linkage, Harmonization, and Quality – a panel chaired by Vivek Rudrapatna (UCSF), Rohit Vashisht (UCSF), Adam Asare (QLHC), Dan Riskin (Verantos), Wanmei Ou (Ontada), and Mindy DeRouen (UCSF).
• Using RWE to Uncover and Address Health Disparities – a panel chaired by Chris Boone (AbbVie), Robert Hiatt (UCSF), Abasi Ene-Obong (54gene), Nuray Yurt (Novartis Oncology), Alice Popejoy (UC Davis Health), and Vic Spain (Genentech)
• FDA RWE/D Draft and Final Guidances – a talk by Motiur Rahman (FDA)
• Fireside Chat – with Vivek Rudrapatna (UCSF), and Hilary Marston (FDA)
• From Real-World Data to Regulatory-Grade Real-World Evidence – a panel chaired by Sheila Walcoff (Goldbug Strategies) with Elaine Katrivanos (Tempus), Kathy Hibbs (23andMe), and Mike Ryan (McDermott Will & Emery)
We look forward to your participation in this most relevant and timely, not-to-be-missed scientific conference where we address the critical topic of RWE/RWE and strive to identify solutions enabling improvements to benefit our healthcare system. Register today to save.
President & Co-founder, PMWC
PMWC 2023 Silicon Valley – January 25-27, 2023