Patient input is an important factor in determining which devices come to market. The Center for Devices and Radiological Health (CDRH) has seen an increase in the number of patient-reported outcome measures being used in clinical studies, and in the amount of patient preference information collected to inform regulatory review.
In order to achieve CDRH’s mission and vision to serve patients, the agency is gathering patient perspectives to advance the development and evaluation of innovative devices, and monitor the performance of marketed devices. By partnering with patients, CDRH can promote patient-centric clinical trials that measure what is most important to patients, inform pre-market benefit-risk assessments, bring beneficial new devices to the market sooner, and develop more patient-friendly information about safe and effective device use. Additional information can be found on the FDA Patient Preference Initiative page and the CDRH Strategic Priorities and Updates page.
Real World Evidence
Real world data (RWD) is data collected from sources outside of traditional clinical trials. These sources may include large simple trials or pragmatic clinical trials, prospective observational or registry studies, retrospective database studies, case reports, administrative and health care claims, electronic health records, data obtained as part of a public health investigation, and registries (e.g., device, procedural, or disease registries).
Real world evidence (RWE), derived from collecting and analyzing RWD elements, can provide data about patients in the setting of their environments—whether at home or at work—and in the social context of their lives. Researchers can tap into these sources to address questions about patient health and the safety and effectiveness of medical products.