The Association for Clinical Research Professionals (ACRP) published in their May journal an essay written by Clinical Research Pathways Executive Director Marjorie A. Speers, Ph.D.
In her piece, Speers discusses the critical role clinical research professionals play in the FDA's Expanded Access program-which permits investigational products to be used outside of a clinical trial, in certain circumstances. These include situations where a critically ill or terminal patient has exhausted standard options but is not willing to give up hope for suitable treatment. She urges professionals involved in clinical trials to familiarize themselves with expanded access and the alternatives available to patients. She suggests they gather and share information, and encourage patients to talk with their treating physician, since he or she must make the expanded access request. By offering information and resources, she writes, clinical research professionals will be performing a valuable service for patients who have exhausted all other treatment options.
The entire article can be found here. Dr. Speers is available to talk with journalists about the issue.