A clinical trial (also called clinical research) is a research study in human volunteers (participants) to answer specific health questions. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.
Clinical trials are important because they serve as the foundation for most medical advances. Without clinical trials, many of the medical treatments and cures we have today wouldn’t exist.
Our clinical trial team includes doctors, nurses, and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
Clinical trials are the best approach for eligible participants to:
Informed consent is a legal protection enforced by the FDA that ensures you have been given detailed information about possible risks and benefits before agreeing to participate in a clinical trial.
Participation in a clinical trial is voluntary, which means you can leave a clinical trial at any time.
A clinical study sponsor refers to an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study or trial. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator.
A placebo looks like a treatment but does not have any medicine in it. Researchers use placebos to help make sure any changes in the participants’ health are caused by the trial treatment. You do not get to choose if you get the trial treatment or the placebo, and you may not know if you get the placebo until after the trial. Not all trials use a placebo.
A “research site” is the physical location where a research study is conducted, such as a university, hospital, or research institute where researchers collect data and carry out experiments as part of their research project; in clinical trials, a research site is a specific location where patients participate in the study under the supervision of medical professionals.
A subject or patient volunteer is someone in a clinical trial who has the condition being studied. Researchers need patient volunteers to learn if new tests, treatments, or preventive measures are safe and effective. Not all trial participants will receive experimental medications or treatments; sometimes, participants may receive a placebo.
Institutional review boards (IRBs) review and monitor most clinical trials in the United States. An IRB works to protect the rights, welfare, and privacy of human subjects.
When a clinical trial ends, researchers will analyze the data to help them determine the results. You will also be informed as to whether you were on the study treatment. You will continue your standard of care with your regular doctors.