Bioethics Meets R&D: The Ethics of Pre-approval Access

Patients with life-threatening illnesses face challenges in accessing potential therapies at the cutting-edge of research and development, which have not yet been proven in a clinical trial. Some pharmaceutical companies produce and provide medicines on a case-by-case basis through expanded access or “compassionate use” programs. The tension among principles of fairness, equity, and compassion are explored in this podcast through a case study about a social media campaign led to an expedited clinical trial for an investigative antiviral medicine. Guests will explore the provocative and emotional stories of patients, family members, advocates, researchers, physicians, and the regulators charged with keeping medicines in the marketplace safe and effective. 

This podcast was a collaboration between The Division of Medical Ethics at NYU School of Medicine and The New York Academy of Sciences.