What is a Clinical Trial?
A clinical trial is a scientific research study that evaluates the safety and effectiveness of new medical treatments, drugs or devices. During a clinical trial, participants must meet eligibility criteria and are monitored for their responses to investigational medications, devices or procedures.
A clinical trial may reveal that the investigational treatment is better than, as good as, or no better than the standard treatment for the condition. A clinical trial may also confirm the discovery of a successful treatment for a health problem that has never had an effective treatment.
Clinical research trials are a partnership and a commitment between research doctors and study participants. They are the final tests in a series of many carefully controlled scientific studies completed to improve health and quality of life.
Additional terms or concepts associated with clinical trials are provided below:
- Food and Drug Administration (FDA): The government agency that sets guidelines on the manufacture, testing and use of drugs and medical devices. All drugs and medical devices must be approved by the FDA before they can be used by the general public. (visit FDA website)
- Informed Consent: The complete and open discussion between clinical investigators and potential study participants of all procedures, benefits, risks and expectations of a clinical trial. The FDA requires all participants to sign an informed consent form before participating in a trial.
- Institutional Review Board: A group of health care professionals that is responsible for assuring there is no unreasonable risk to the participants, and that informed consent accurately informs the participant about their role in the study.
- Investigational Treatment: The drug or medical device being tested during a clinical trial.
- Pharmaceutical/Biotechnology Company: A business that researches, develops tests, manufactures and/or sells medical drugs or devices.
- Protocol: A detailed plan carefully designed by the sponsor of the clinical trial. It sets guidelines for a trial and usually involves several different trial locations.
- Sponsor: A pharmaceutical company, research institution, or other health organization that funds a clinical trial and designs the protocol.