Clinical trials are the proving ground for new drugs, vaccines and devices. They provide data that will determine whether the FDA approves a manufacturer’s application for marketing approval. Potential racial, ethnic and other differences in response to drugs are important to the FDA’s efforts to help ensure that the safety and effectiveness of drugs are studied in all people who will use the products once they are approved.
Ensuring meaningful representation of minorities in clinical trials for regulated medical products is fundamental to the FDA’s regulatory mission and public health. The FDA is working to increase the participation of people in racial, ethnic and other minority groups in the clinical trials that test new medical products. For more information on minorities and clinical trials, click here.
BlackDoctor.org: Treatment of HIV/AIDS has advanced greatly in the last 30 years. What new research, policies or initiatives should we be aware of?
Dr. Bull: The FDA is part of the Department of Health and Human Services (HHS). Under the leadership of HHS, there are several initiatives underway to help prevent HIV and improve the health outcomes of people living with HIV. These include:
National HIV/AIDS Strategy– this plan charts the course for the federal government and other sectors to respond to HIV in the United States. This plan was developed with extensive stakeholder input and provides strategies, evidenced based practices, and lessons learned from the local, regional, and state levels.
Secretary Minority AIDS Initiative Fund (SMAIF)- this fund was established by Congress in 1999 and provides funding to HHS agencies to support programs to reduce new infections, improve HIV related outcomes, and reduce HIV related health disparities.
AIDS.gov– uses electronic communications, such as a website, blog, and social media to raise the profile of federally supported HIV information and services. AIDS.gov also helps to coordinate activities across HHS to help cross-promote key messages, policies, and resources.
HIV Treatment Works Campaign– this campaign is designed to raise awareness on how to overcome barriers to get in HIV care and stay on a treatment regimen.
To learn more about the laws governing the FDA’s role in clinical trial participation, FDASIA Sec. 907 and the FDA’s Action Plan, see below:
FDASIA Section 907: Inclusion of Demographic Subgroups in Clinical Trials (More about FDAISA in general can be found here)
FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data (August 2014)