Date Approved


Degree Type

Open Access Thesis

Degree Name

Master of Science (MS)

Department or School

Health Sciences

Committee Member

Stephen Sonstein, PhD


Today, the vast majority of drugs available for patient use have gone through a rigorous system of human clinical trials supervised by the Food and Drug Administration (FDA), to ensure the drugs are safe and efficacious. There are now citizen advocacy groups that seek use of drugs not yet approved by the FDA, to be administered to terminally ill patients who have exhausted all other available means of therapy. The FDA has programs for terminal patients, under the supervision of their physicians, to use unapproved drugs; however, the advocacy groups seek access to drugs in much earlier phases than is now allowed, raising serious safety concerns for patients. Use of drugs outside of the clinical trials system undermines the integrity of the FDA’s drug development process by slowing enrollment, which in turn slows approval and timely access of safe and efficacious drugs to all of society.