March
2

Research Ethics and Policy Series (REPS) | Alison Bateman-House, PhD, MPH, MA

12:00pm - 1:00pm • Class of 1962 Auditorium, John Morgan Building (3620 Hamilton Walk)

2020-03-02 12:00:00 2020-03-02 13:00:00 America/New_York Research Ethics and Policy Series (REPS) | Alison Bateman-House, PhD, MPH, MA What Expanded Access and Right To Try Can and Cannot Do   The most common way for people in the United States to get access to investigational medical products is by participating in clinical trials. For patients who are unable to participate in clinical trials but who wish to try an experimental drug, device, vaccine, or other medical product, there are two pathways that permit non-trial access to products that are still in clinical development and not approved for any use. These are Expanded Access, which has existed for several decades, and Right to Try, which is much newer. Alison Bateman-House will compare and contrast the two pathways and explain why Expanded Access is preferable to Right to Try, both for patients and for the companies whose investigational products will be involved in such “compassionate use” attempts. She will underscore that the existence of such regulatory pathways are necessary but far from sufficient for patients to be able to use experimental medical products outside of clinical trials and highlight what other obstacles, real and perceived, reasonable and unreasonable exist. Alison Bateman-House, PhD, MPH, MA Assistant Professor, Division of Medical Ethics New York University Langone Medical Center Commentary by Robert Vonderheide, MD, DPhil John H. Glick Abramson Cancer Center Professor Perelman School of Medicine Class of 1962 Auditorium, John Morgan Building (3620 Hamilton Walk) Penn Medical Ethics

What Expanded Access and Right To Try Can and Cannot Do
 

The most common way for people in the United States to get access to investigational medical products is by participating in clinical trials. For patients who are unable to participate in clinical trials but who wish to try an experimental drug, device, vaccine, or other medical product, there are two pathways that permit non-trial access to products that are still in clinical development and not approved for any use. These are Expanded Access, which has existed for several decades, and Right to Try, which is much newer. Alison Bateman-House will compare and contrast the two pathways and explain why Expanded Access is preferable to Right to Try, both for patients and for the companies whose investigational products will be involved in such “compassionate use” attempts. She will underscore that the existence of such regulatory pathways are necessary but far from sufficient for patients to be able to use experimental medical products outside of clinical trials and highlight what other obstacles, real and perceived, reasonable and unreasonable exist.

Alison Bateman-House, PhD, MPH, MA
Assistant Professor, Division of Medical Ethics
New York University Langone Medical Center

Commentary by Robert Vonderheide, MD, DPhil
John H. Glick Abramson Cancer Center Professor
Perelman School of Medicine


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