The COVID-19 pandemic has brought many issues to the public’s attention that used to be of interest only to clinical research and drug development communities: clinical trial design, efficiency and timelines of clinical research studies, drugs’ approval process, and pre-approval access to investigational therapies are just a few. Read more
Expanded access, which is treatment access to experimental drugs (also referred to as "compassionate use" or "pre-approval access"), has generated increasing interest and debate over the last several years. On March 7, PRIM&R hosted a webinar, Pre-Approval Access to Drugs in Development: Navigating the Changing Regulatory, Ethical, and Legal Landscape, to educate HRPP professionals on FDA guidance, recent legislation, and ethical questions related to expanded access. The webinar featured Richard Klein, the former director of the FDA's Patient Liaison Program in the Office of Health and Constituent Affairs, and Beth E. Roxland, JD, MBioethics, an Attorney, Bioethicist, and Senior Advisor on Law, Health Policy and Ethics at Roxland Consultants, Ltd. After the webinar, Mr. Klein responded to some of the attendee questions time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand. Read more
In this week's Research Ethics Roundup, we explore how new approaches are being used to address longstanding questions, such as those raised by expanded access or compassionate use, and chart a course for the future of biomedical innovation.
Company Creates Bioethics Panel on Trial Drugs: In an effort to address concerns related to compassionate use requests, Johnson and Johnson announced last week that they have appointed bioethicist Arthur L. Caplan, PhD, to "to create a panel that will make decisions about patients' requests for potentially lifesaving medicine."
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