While randomized clinical trials (RCTs) are considered the gold standard of clinical research designed to establish evidence of benefit for a medical intervention, there is growing interest in ...

In our time at Takeda Oncology, we’ve had the opportunity to observe how real-world evidence (RWE) obtained outside of randomized controlled trials (RCTs) has been playing an increasingly important ...

The FDA’s final guidance for the use of real-world evidence (RWE) was touted by FDA commissioner Marty Makary as opening the door to the use of existing de-identified data in premarket device ...

DURHAM, N.C., Nov. 3, 2021 /PRNewswire/ -- Target RWE, a leading real-world evidence (RWE) solutions company for the healthcare industry, shared results from a recent TARGET-NASH study that revealed ...

The American Journal of Managed Care® (AJMC®): From your perspective, how can real-world evidence (RWE) be used to gain insight into the field of myeloma? RIFKIN: Over the years, we’ve collected a ...

With an eye toward better tracking the use of real-world data (RWD) to generate real-world evidence (RWE), the US Food and Drug Administration (FDA) on Wednesday drafted guidance to help sponsors ...

Patient-centric evidence, such as PROs and RWE, offers insights into patients' needs, enhancing drug development beyond traditional endpoints. Challenges include increased complexity and regulatory ...

The Food and Drug Administration and Brigham and Women’s Hospital are diving deeper into a program announced last year to incorporate real-world evidence into regulatory decision making as part of a ...

In September, at the US National Academies of Science (Washington, DC), Scott Gottlieb, the newly appointed US Food and Drug Administration (FDA) commissioner, and Janet Woodcock, long-time director ...