What are clinical trials?
Clinical trials are research studies that test if an investigational treatment is safe, how well it works, and to find the right dose. Regulatory authorities, such as the Food and Drug Administration, evaluate the information (data) received by a sponsor (company) to decide if the investigational treatment should be approved for use.
To ensure that each conducted trial is ethical and protects the rights of the volunteers, each clinical trial procedure (protocol) is reviewed by an independent group of experts called an Institutional Review Board (IRB). The IRB is made up of doctors, researchers, and members of the scientific community. Before a clinical trial can begin, the IRB must review and approve the trial procedure.
Why are clinical trials important?
Participating in a clinical trial contributes to medical knowledge. The results of these trials can make a difference in the care of future patients by providing information about the benefits and risks of the potential treatment.1
The clinical trial process: What to expect?
Participating in a clinical trial can be both exciting and a bit confusing. Before a person can take part in a clinical trial, the staff at the trial site must provide information about why the trial is being conducted. This process, called informed consent, provides the volunteer with the following information so that they may make the best decision on whether or not to participate in the clinical trial:
- How long the trial is expected to last?
- What treatments are being studied?
- What will occur at each visit?
- What are the participant’s rights during the trial?
- What will happen if the volunteer decides not to participate?
- What are the responsibilities during the trial?
- What are the possible risks and discomforts during the trial?