Clinical trials are research studies where volunteers agree to receive and test new drugs or other treatments so that researchers can evaluate how well they work. Clinical trials are the key to find out if a new a new drug, diet or medical device, is safe and effective in people. Participants can also help measure results by reporting on how they feel and allowing researchers to conduct follow-up exams that might include blood tests or other testing. In order to start a clinical trial, the U.S. Food and Drug Administration (FDA) must approve it to move forward. Researchers get the approval by perfomring laboratory tests and studies in animals to see how safe their medication or practice is. If the test shows favorable results, the FDA gives approval for the treatment to be tested in humans, beginning with a small group of participants to test safety. FDA approval for testing in clinical trials, does not guaruntee FDA approval of the product, but ensures safety measures are being taken before receiving results.
Scientists across the United States are conducting clinical research to prevent, treat, and better understand COVID-19. The National Institutes of Health (NIH) has set up a partnership among government, industry, and university researchers to identify drugs and other treatments that are promising. These are called Accelerating COVID-19 Therapeutic Interventions and Vaccines or ACTIV trials. Clinical trials are the fastest way to find successful treatments for COVID-19. Participants are assigned randomly to either a test group that receives the drug being tested, or to a control group that receives a placebo (a treatment with no drugs in it). Both groups also continue to receive care for COVID-19. Neither the participant nor the doctor knows whether the treatment is the drug or the placebo to prevent members of the research team or participants from influencing the results. Only a group of researchers who are part of a separate team knows what participants received.
Diversity in clinical trials are essential for researchers to measure the accuracy of COVID-19 medications across the whole population. Men and women of color and different ethnicities are disproportionately accounted for in many clinical trials.