Clinical Trials Updates
ClinicalTrials.gov is maintained by the National Library of Medicine and offers an updated list of privately and publicly funded studies conducted around the world.
Use of Real-World Evidence (RWE) for Device Development
Medical products are usually tested under highly structured, randomized, clinical trials. However, the Food and Drug Administration is beginning to see the value in using data acquired from sources that aren’t the traditional clinical trials to assist in making regulatory decisions. The real-world data (RWD) can be acquired from retrospective case reports, electronic health records, or pragmatic clinical trials. The RWD provides real-world evidence (RWE) to assist in the regulatory process for medical devices. The FDA has issued guidelines regarding the use of RWE. More information can be found here.
2018 FDA/NCATS Report on Unmet Medical Device Needs for Patients with Rare Diseases
The FDA and the NIH National Center for Advancing Translational Sciences (NCATS)/Office of Rare Diseases Research (ORDR) conducted this needs assessment to better understand unmet medical device needs for rare diseases; generate meaningful data to inform patients, practitioners, policymakers, and device developers on the needs, barriers, and incentives related to medical device development for rare diseases; and increase public awareness of these needs. See full article here.