What is a Clinical Trial?
A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.
A clinical trial is a research study that is designed to answer a question about cancer treatment. Preclinical or laboratory studies are performed using animals, human tissue (biopsies), or computer simulations to study the potential effect of experimental drugs, radiation delivery systems or treatment schedules. Phase I trials are the first step in testing a new treatment on humans. In these studies researchers look for the best way to deliver a new treatment (for example, How much drug or radiation should be given and what is the best way to deliver the new treatment?). Researchers also assess any side effects that result from this new treatment. Since this is the first stage in gathering information about the new treatment only a small number of patients, who would not be helped by other known treatments, are entered on a Phase I study. Phase II trials focus on learning whether the new treatment has an anticancer effect (for example, Does it shrink or destroy a tumor?). Phase II stu
Clinical trials, also known as clinical studies, are research studies in which scientists and doctors test new drugs and treatments to see if they will improve health. Many of today’s treatments for cancer are based on the results of past clinical trials. Because of progress made through clinical trials, many people treated for cancer are now living longer. Clinical trials are divided into four phases. Phase 1 trials: These trials are the first time a new drug or treatment is given to humans. They are normally carried out in a small number of volunteers (typically 6-20 people) who may include healthy volunteers or patients with the disease for which the product is intended as a treatment in order to find out how safe the treatment is. They also look at how a new drug should be given (by mouth, injected into muscle or the bloodstream, etc.), how often and at what dose. Phase 1 trials can also involve patients for whom standard therapies have failed and for whom no other therapies are av
