The FDA’s device center has published two guidances dealing with patient engagement in relation to the conduct of clinical trials, including a final guidance for patient input into clinical trial design. The final guidance is mum, however, as to whether consultations with patient representatives constitutes a violation of the Anti-Kickback Statute (AKS), a predicament the Advanced Medical Technology Association (AdvaMed) said may represent a serious legal hazard for device makers.
Recognizing that people with cancer want to know what symptoms they may experience and how a particular therapy may affect their quality of life, the FDA is issuing a draft guidance advising sponsors on incorporating a core set of patient-reported outcomes (PROs) into cancer clinical trials.
Despite the demonstrated benefits of using patient-reported outcomes (PROs) in clinical trials assessing new cancer drugs in adults, PROs are rarely used in pediatric cancer trials. Hoping to change that, the FDA is convening the pediatric subcommittee of its Oncologic Drugs Advisory Committee (ODAC) May 11 to discuss how to effectively use a pediatric form of the PRO version of the common terminology criteria for adverse events.
Patient perspectives on medical device development are becoming much more central to the U.S. FDA’s regulation of devices, thus the August 2020 draft guidance for selection of patient-reported outcome instruments for device evaluation.
Patient perspectives on medical device development are becoming much more central to the U.S. FDA’s regulation of devices, thus the August 2020 draft guidance for selection of patient-reported outcome (PRO) instruments for device evaluation. However, the draft is sufficiently vague on the question of when an existing PRO can be tweaked without an entirely new validation study to prompt the Advanced Medical Technology Association (Advamed) to press the agency for more clarity on that point.
At a session of the American Association for Cancer Research Virtual Annual Meeting II, multiple FDA regulators gave presentations on various topics to help drug companies understand the ever-evolving oncology regulation.