Article published in the Journal of the Association of Clinical Research Professionals 

Written by Executive Director Marjorie A. Speers, Ph.D.

As a clinical research professional, most of your interactions with patients are related to their involvement in clinical trials: recruiting, assessing, and enrolling participants; obtaining informed consent; administering trial procedures; and monitoring patient responses to the investigational drug, biologic, or medical device. In some cases, your site might only conduct clinical trials and not offer treatment to patients who are not enrolled in a trial. Even so, eventually you might be approached by a patient who is interested in the U.S. Food and Drug Administration’s (FDA’s) Expanded Access Program, which permits an investigational product to be used outside a clinical trial for treatment in certain circumstances.

Perhaps the patient doesn’t qualify for a trial and has exhausted all other treatment alternatives. Maybe he or she or lives too far from a study site to participate. Regardless of the reason, the patient is out of standard options and not willing to give up hope for a suitable treatment.

How can you help? Prepare for this possibility ahead of time. Then you’ll be ready with information and, ideally, a policy on whether, how, and when your site will participate in an expanded access use.

Click here to read the full article in the Journal of the Association of Clinical Research Professionals.