WHAT ARE CLINICAL TRIALS?
Clinical trials are research studies in which volunteers receive new drugs or other treatments so that researchers can evaluate how well the treatments work. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device, is safe and effective in people. In addition to taking the drugs or treatments being tested, participants may help measure results by reporting on how they feel and by allowing providers to conduct follow-up exams that might include blood tests or other testing.
Before the U.S. Food and Drug Administration (FDA) approves a clinical trial to begin, researchers perform laboratory tests and studies in animals to test safety and performance. If these studies show favorable results, the FDA gives approval for the treatment to be tested in humans, beginning with a very small participant population to test safety.
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Clinical trials for...
ARE THERE CLINICAL TRIALS FOR COVID-19?
Many scientists in the United States are conducting clinical research to prevent, treat, and better understand the illness. 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 most promising. These are called Accelerating COVID-19 Therapeutic Interventions and Vaccines or ACTIV trials. Five ACTIV trials are under way in many different locations and four other trials with similar designs and goals are associated with ACTIV. The treatments under study in these trials are for patients at every stage of illness—at home (outpatient), in the hospital (inpatient), or in recovery (convalescent) for patients recently discharged from the hospital.
The gold standard for testing drug treatments in people is the randomized, double-blind, placebo-controlled clinical trial. These clinical trials are the fastest and most rigorous way to find successful treatments for COVID-19. In these trials, participants are assigned randomly to either a test group that receives the drug being tested, or to a control group that receives a placebo, which is a treatment that has none of the active drug in it.
Both groups also receive other care that is standard for their stage of COVID-19 illness. Because neither the participant nor the doctor knows whether the treatment is the drug or the placebo, they are called “double-blind” trials. This double blinding prevents members of the research team and study participants from influencing the results. Only a group of researchers who are part of a separate team, the Data Safety Monitoring Board, knows what participants received. This team closely monitors the safety of all participants.
Choosing to join a clinical trial is an important personal decision. Talk with your doctor about joining a clinical trial.
You may also call to get more information about joining an ACTIV or ACTIV-associated clinical trial.
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I HAVE COVID-19. WHY SHOULD I PARTICIPATE IN A CLINICAL TRIAL?
A COVID-19 diagnosis can leave you unsure and eager to learn what to do next. After speaking with your healthcare provider about your diagnosis and any symptoms you are experiencing, you should consider participating in a clinical trial. The five ACTIV clinical trial opportunities discussed above are for adults with mild to moderate COVID-19 symptoms, individuals who are in the hospital with serious symptoms, and those who have been exposed to someone who has tested positive for COVID-19.