Frequently Asked Questions on Research studies and trials
WHAT ARE CLINICAL TRIALS?
Clinical research trials are used to test and evaluate investigational drugs and treatments. Before an investigational drug or treatment can be considered for approval by the U.S. Food and Drug Administration (FDA), it must be shown to be safe and effective in these carefully monitored studies.
WHY DO PEOPLE PARTICIPATE IN CLINICAL TRIALS?
People may be interested in clinical trials for a variety of reasons. Some people participate in clinical trials as a way to contribute to medical science and to help doctors and researchers find better ways to help others. Others participate in clinical trials to receive investigational treatments because their illness is not responding to standard treatment. Their hope is that the study treatment – possible an investigational drug or a combination of drugs – will work better for them than standard therapy. This will not always be the case, because some investigational treatment strategies may not work as well as standard therapies or may have unexpected side effects. For this reason, everyone in a clinical trial is carefully monitored.
Frequent study – related medical exams and tests are performed to ensure safety.
HOW ARE PEOPLE IN CLINICAL TRIALS PROTECTED?
Researchers follow strict ethical and scientific principles to make sure that patients are protected and valid results are produced. A plan of how the study will be run, which is called a protocol, is written to ensure that every research involved in the study follows the same and scientific principles.
The protocol is written by the study’s sponsor. All researchers taking part in the study will use the same protocol. It describes how the study will be conducted in great detail: the number of participants to be enrolled, the amount of drug to be used, the type of medical test to be provided, etc.
To ensure patient safety, the protocol must be reviewed and approved by the organization that sponsors the study as well as by an Institutional Review Board. This Board consists of people with a variety of backgrounds and may include clergy, health professionals and members of the general public. In the review of the protocol, the board seeks to ensure that participants in the study will not be exposed to unreasonable or unethical risks.