A clinical trial is a research study used to determine whether new drugs are both safe and effective. All clinical research studies are developed jointly between the pharmaceutical companies and the Food and Drug Administration. All clinical trials are based on a set of rules called a protocol, which describes who may participate, the schedule of tests, procedures and medications, dosages, and length of the study.
The FDA has strict safeguards to protect people who choose to participate in clinical trials. All clinical trials in the U.S. must be approved and monitored by an Institutional Review Board (IRB), which is an independent company not associated with the FDA or the pharmaceutical company.
Before even deciding whether or not to participate in a study, a person will want to learn the key facts about a study. An informed consent document will be given to potential participants, which will outline such things as the procedures in the study, risks and side effects of the medication being tested, and other available treatments. The health and safety of patients is monitored regularly throughout the study.
Participants are free to leave the study at any time. Generally, patients are paid a transportation stipend for participation in the study. This amount will vary from study to study. It is generally paid upon the patient’s completion of the study.