The Food and Drug Administration (FDA) has released its draft guidance on real world data (RWD). The guidance is intended to support submissions that incorporate data from electronic health records (EHRs) and medical claims data. The document highlights data sources, successfully capturing and […]
Data Expert Discusses 9 RWE Applications in Healthcare and Pharma R&D
Vice President of Business Development & Real World Evidence (RWE) at ArborMetrix Benjamin Echeazu discusses the growing use of RWE in a wide range of applications—from drug development to tangibly improving patient outcomes. He details nine use cases where RWE and real world data (RWD) informed […]
ISPOR Seeks Comments for FDA Guidance on RWD
The International Society for Pharmacoeconomics and Outcomes (ISPOR) is seeking comments for a draft guidance document published by the Food and Drug Administration (FDA) detailing how to select appropriate real world data (RWD) sources. The comment period closes in early November. “The survey […]
Syntropy and UCI Unite in 5-Year RWD Collaboration to Improve Patient Outcomes
Syntropy and the University of California, Irvine (UCI) will collaborate in a five-year partnership intended to directly improve patient outcomes using real world data (RWD). RWD sources, such as patient-recorded data and clinical records, will be securely shared and analyzed. UCI’s Vice […]
Syapse Announces RWD Partnership with Merck to Accelerate Oncology Research and Improve Patient Outcomes
Real world evidence (RWE) leader Syapse has announced a partnership with Merck. Together, the companies will utilize real world data (RWD) to understand the outcomes of patients living with cancer and improve care. The companies will leverage clinical, outcomes, and molecular data using the Syapse […]
Aetion eBook Highlights the Impact of RWE in Successful Drug Approvals Ahead of FDA Framework
Aetion has published an eBook detailing how real world data (RWD) and real world evidence (RWE) can impact drug approvals by the Food and Drug Administration (FDA). The eBook includes case studies where RWE led to the approval of drugs and biologics. The guide also compares RWE use in 10 areas of […]
Part 2 of Aetion’s ICPE Research Spotlight Highlights RWD in COVID-19 Research and Updated RWE Guidance
According to Aetion, key highlights of the August ICPE All Access Meeting hosted by the International Society for Pharmacology (ISPE) include successfully using fit-for-purpose real world data (RWD) to understand the impact of COVID-19. Other major topics included comparisons between real world […]
Quantitative Scientist Discusses Considerations for HTAs Using RWD
Dr. Philani Brian Mpofu discusses important considerations for health technology assessments (HTAs) using real world data (RWD) to understand drug efficacy. He highlights the intricacies of RWD studies using a fictional drug, vidumab, manufactured by the fictional company Eland Pharma. “After […]
Syneos Health Executive VP and Data Expert Discusses RWE and Aetion Collaboration
Executive Vice President of Real World Evidence (RWE) and Late Phase at Syneos Health Javier Jimenez discusses major industry trends and his organization’s recent partnership with Aetion. RWE can be used throughout the drug development pipeline to improve patient outcomes. “We can empower market […]
Interview With RWE Expert on Expectations for FDA Framework
In a recent interview with The Evidence Base, real world evidence (RWE) expert Sreeram Ramagopalan shared his thoughts on the changing RWE landscape. He also discussed what the Food and Drug Administration (FDA) will—and won’t—include in its upcoming RWE guidelines. “Our expert for this […]
