Caroline Marra

Oct 25, 2024 | healthaffairs.org | Caroline Marra |Amy P. Abernethy |Sean Tunis

Medicare has recently endorsed the concept of “fit-for-purpose” (FFP) studies to support ongoing evidence generation as a condition of coverage for selected emerging medical products.

Oct 24, 2024 | healthaffairs.org | Caroline Marra |Amy P. Abernethy |Sean Tunis

When Medicare coverage for a drug, device, or other medical technology is conditioned on additional evidence development, several important policy questions arise: What will be the utility of the evidence generated for informing coverage decisions and, ultimately, the care of Medicare beneficiaries? What will be the burden of conducting the study? And how will the evidence development affect access to the technology by patients?

Feb 2, 2024 | ascpt.onlinelibrary.wiley.com | Caroline Marra |Ariel Stern

WHAT IS CURRENT KNOWLEDGE ON THE TOPIC? Digital health technologies (DHTs) can enable more patient-centric therapeutic development by increasing trial inclusiveness, lowering participation burden, and capturing aspects of health that are meaningful to patients but cannot be easily measured using traditional data collection methods. Although DHT use in clinical trials overall has grown, uncertainty remains about how often DHTs are used in product development trials in particular.