for Veterans and the Public
What is a clinical trial?
A clinical trial is a research study that tests a new medicine to see if it is safe and works well. When a new medicine (or drug) is first developed, you cannot get it by prescription. Researchers must first test it in a laboratory with animals. Then, they must do a clinical trial in a hospital or clinic to test it in people. They test it to see if it is safe and to see how much of the medicine (or what dose) is enough to work.
The Food and Drug Administration (FDA) is a government agency that decides if a new drug is safe enough to give to patients by prescription. It looks at the results of the clinical trials to make this decision. Testing drugs for HIV is very important, and clinical trials are a way to find new and better medicines. All medicines that you can now get to treat HIV were first tested in clinical trials.
Clinical trials follow a set of rules called a protocol. The protocol says who can participate, how long the study is, and which tests need to be done.
Clinical trials are managed by doctors and are usually run by nurses or other health care professionals. The clinical trial staff will follow your progress closely and can tell your regular doctor what is happening with your treatment.
Trials are also monitored by an institutional review board (IRB). This is a group of people who reviews the clinical trial regularly to protect your rights, safety, and well-being.
When you are in a clinical trial, you may need to see the study doctor often. This is because they want to check the effects of the medicine carefully. Because clinical trials are research, they will often test the real drug against a placebo (or sugar pill). You will be told if the trial involves one group of participants taking a placebo, but you may not know if you are taking the medicine or the placebo until the clinical trial is over.