Clinical trials are considered to be biomedical or health-related research studies in human beings that follow an approved, pre-defined protocol. Clinical trials are conducted to collect safety and efficacy data for new drugs or devices. The most commonly performed clinical trials evaluate new drugs, medical devices, biologics, psychological therapies, or other interventions. All clinical trials have specific guidelines about who can participate; a potential participant must qualify for prior to participating in a clinical trial. In most clinical trials, one group of patients will be given the experimental treatment, while the control group is given the standard treatment for their particular injury or disease.Clinical trials are sponsored and/or funded by a variety of organizations and/or individuals and every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. The IRB also ensures that clinical trials are ethical and the rights of study participants are protected. All institutions that conduct research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research being conducted.
Some of the benefits of participating in a clinical trial include
- Playing an active role in your own health care.
- Gaining access to new research treatments before they are widely available.
- Obtaining expert medical care during the trial.
- Helping others by contributing to medical research.