How does a clinical trial work?
To start, the research team must first determine the objective of the study – for example, whether an experimental treatment is safe or whether a treatment known to work for hyperhidrosis on one part of the body will work for hyperhidrosis on another part of the body. The research team then designs the study to answer that question, including developing a protocol for the trial. Clinical trials with human subjects follow only after the completion of tests using laboratory animals. These trials fall into four categories called phases. In Phase I a trial tests a potential new treatment with a small number of volunteers (20-80 individuals) to determine the treatments safety and potential side effects. Phase II studies test a treatment with known dose and side effects with a larger number of volunteers to learn more about side effects, how the body responds to the treatment, and whether the treatment is effective in treating the condition. The new treatment is compared with commonly used t
Here are the basic parts of a clinical trial.Basic Research. Before a clinical trial can start, doctors must have a theory about why a new therapy might treat a disease. It usually takes years of research to develop a theory.Animal Studies. Doctors first test the new treatment in animals to find out if it might be helpful or harmful to people.The Proposal. After the doctors involved in the study prove that the new treatment is safe in animals, a proposal is submitted to a group of doctors, statisticians, scientists, and people from the community who are members of an independent institutional review board (IRB). Each hospital or research center has its own IRB. It is up to the IRB to decide if the therapy is safe enough for testing in a small group of people.Finding Patients. After getting approval from the IRB, doctors must find patients for the study. All patients who take part in a clinical trial are volunteers.Informed Consent.
