The U.S. FDA’s advisory hearing on multi-cancer detection (MCD) tests suggests that the premarket requirements for these tests will be rigorous, if only because the agency stated at the outset of the hearing that it sees these tests as class III devices. However, the advisory committee also suggested that a registry be established to track outcomes for these tests, a requirement that is likely to prove expensive and time-consuming to fulfill.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has unveiled two guidances for the use of real-world evidence (RWE) in regulatory decision-making. The policy seems limited to pharmaceutical clinical trials, with no indication when it will be expanded to include medical technology.
While stakeholders have concerns about the costs of registries for medical devices, they are still generally seen as less expensive and simpler to administer than randomized, controlled clinical trials (RCTs). A new journal article compares the quality of the data from a registry and the data generated by a clinical trial, and despite an interest in ascertaining whether registry data provided similar data quality, the authors concluded that registry data is still more useful as a means of supporting, rather than supplanting, the RCT.
Two major papers on repurposed drugs for COVID-19 by researchers from Brigham and Women’s Hospital face intense skepticism from the research community, prompting the editorial boards of TheNew England Journal of Medicine and The Lancet to publish Expressions of Concern on the validity of the underlying data. Such expressions are often the first step toward an outright retraction.