Clinical Trial Overview
Clinical trials study a drug’s safety and effectiveness.
When found to be safe and effective, they may become tomorrow’s standard of care. Clinical trials study many things, such as:
- New drugs not yet approved by the U.S. FDA (Food and Drug Administration)
- New uses of drugs already approved by the FDA
- New ways to give drugs, such as in pill form
- Use of alternative medicines, such as herbs and vitamins
- New tests to find and track disease
- Drugs or procedures that relieve symptoms.
Clinical trials are carefully designed, reviewed, and administered.
The principal investigator (PI) is the person in charge of the trial. He or she is a scientist who’s an expert in what the clinical trial is about. The PI takes the lead in designing the clinical trial, choosing the research team, and carrying out the study. Often, other scientists, called investigators, are part of the research team.
Clinical trials need to be approved before they can start. Clinical trials need sponsors since they can’t be done without money or other support. Sponsors may include government agencies, pharmaceutical (drug) companies, and non-profit organizations. Sponsors of the clinical trial review the research plan. Funding or other support is given by the sponsor once the research plan is approved.
Clinical trials need approval from an IRB (Institutional Review Board). An IRB is a group of people chosen by the health care center where patients will be enrolled into a clinical trial. Each IRB includes five members. These members must include a scientist, someone who is not a scientist, and someone who is not from the health care center. The IRB reviews the research plan to make sure the rights and welfare of patients are protected. After the trial has started, the IRB reviews its progress at least every year.
DSMBs (Data and Safety Monitoring Boards) review the progress of a clinical trial after it has started. Members of the DSMB are experts in clinical trials. They assess if patients are safe, the data is complete, and if the test or treatment is working. DSMBs do not review all clinical trials, only the ones recommended for additional review by the IRB.
What each clinical trial has to offer to patients differs. However, there are four general benefits of participating in clinical trials. First, you’ll have access to cutting edge cancer treatments. Second, you have the opportunity of being treated by experts. Third, the results of your treatment—both good and bad—are carefully tracked. Fourth, the results can help other patients with cancer.
Clinical trials have risks too. Like any test or treatment, there may be side effects. New tests or treatments may not work as well as or better than the ones currently in use. Potential downsides may include additional paperwork, more trips to the hospital, and out-of-pocket cost.