What is a clinical trial?
Clinical trials are carefully designed experiments that allow scientists to test their research questions with people. There are many different kinds of research questions, and have evolved over time. In HIV, the early clinical trials tested new drugs for treatment of the disease and associated opportunistic infections. More recently, researchers have been testing potential vaccines, microbicides and New Prevention Technologies, which could prevent infection or limit its effect. The goal is to determine if the treatment being tested is safe, how well it works, and if it should be approved for use in the general population.
New prevention technologies are also known as biomedical interventions. This refers to a group of HIV prevention tools that employ medical interventions to reduce the risk of HIV infection. This category of HIV prevention includes male circumcision, microbicides, PEP, PrEP, preventive and therapeutic vaccines, and treatment as prevention.
How does a trial work?
A clinical trial is just one stage in the process of developing a new treatment. The entire process includes several steps: identifying a possible treatment; testing it on animals; getting approval for a clinical trial; running the trial; analyzing the results; applying for a license; and getting approval to use the treatment in the general population. This process can take many years. Even when a treatment is put on the market, researchers may want to continue to investigate new ways of using it to reduce the frequency of dosage, to reduce side effects or to test it in new ways to administer the treatment.