A Comprehensive Look at Clinical Trials

The Purpose of Clinical Trials

In order for any medication to be approved by the Food and Drug Administration (FDA), it must be tested in clinical trials. Clinical trials show if a medication works and if it is safe.

At the beginning of the AIDS epidemic, people with HIV and AIDS flocked to clinical trials. At that time, no anti-HIV medications were available by prescription. The only way to get HIV treatment was through clinical trials. The medications were experimental -- researchers did not know exactly what effects they would have in humans. But people were willing to take the risk; there were simply no other options.

Women, people of color, and other affected populations have been historically under-represented in HIV-related clinical trials whose participants have been primarily white males. In order to better understand the way that HIV and anti-HIV medications work, all populations must be represented in clinical trials.

Even though there are approved medications for HIV, clinical trials are still extremely important. Researchers are working to develop medications with fewer side effects and easier dosing. These treatments must be tested in clinical trials. There are also trials that test different combinations of approved medications, and trials without medications (called observational trials) that look at behaviors or study disease progression. Without volunteers for these trials, progress in understanding and treating HIV is impossible.