The Clinical Trial Process
There are many reasons for a clinical trial. When studies are done, they are designed to advance scientific knowledge while protecting trial subjects. Our staff of researcher professionals follow specific guidelines to ensure patients’ safety and privacy.
Before any new treatment is tested in patients, investigators conduct studies in research labs. This is usually followed by other forms or various and thorough testing. If this research is successful, the FDA can approve the treatment for testing in humans. At this point the study is marked by phases. Researchers must also design a protocol. This is a study plan that maps out the criteria for participation, schedule of procedures and treatments, and length of the study.
Each Sponsor or Pharmaceutic Company has an independent Institutional Review Board (IRB) that reviews and approves the protocol, consent form, and all other documents for each study. In addition, the IRB reviews continually monitors and reviews the study as long as the study is active. In order to get approval for a study, the the study must protect the rights of study participants and ensure that the study does not present undue risks to the participants.
Most clinical research progresses in phases. This allows researchers to ask and answer questions in a way that yields reliable information about the study and treatment process. Most clinical trials are classified into one of three phases:
1. Phase I trials are the first step in testing a new treatment in humans. In these studies, researchers may evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen. About 70 percent of experimental drugs pass this initial phase of testing.
2. Phase II trials focus on evaluating how well the new treatment works. They also continue to test the safety of the treatment. This second phase of testing may last from several months to two years, and involves up to several hundred patients. About one-third of experimental drugs successfully complete both phase I and phase II studies.
3. Phase III trials compare the results of people taking the new treatment with results of people taking standard treatment. Investigators usually assign participants to the standard treatment group or the new treatment group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors’ offices, clinics, and health centers nationwide.
An Independent Clinical Trial Center