FDA EFIC and African American Mistrust of Clinical Research

Oct 19, 2018 | African Americans, Clinical Trials, FDA, Informed Consent, Minority Participation in Clinical Trials

Harvard recently completed a study we link to here. FDA Exception for Informed Consent trials are applied to investigative therapies for people impacted by life-threatening conditions—e.g. cardiac arrest, etc. They need immediate treatment prior to ability to provide informed consent. Hence the informed consent exception. Nearly 30% of the patients of these trials are African America—although they represent only 13 percent of the U.S. population. Only 8 percent of the trials were considered beneficial. Reports such as these highlight that there is considerable ways to go in terms of racial bias, race relations and equality in the healthcare system.