Clinical Research and Clinical Trials

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Clinical research is the testing of drugs or treatments in humans. Sometimes these are new drugs or treatments; sometimes these are existing drugs or treatments being used in a different way.

Often, clinical research takes place once all other forms of study and testing (applied and basic science research) have been successfully concluded. Nearly all clinical research is conducted as a clinical trial. In fact, the terms "clinical trial" and "clinical research" are sometimes used interchangeably.

A clinical trial is a research study in human volunteers that is formed to answer specific health questions. Researchers construct clinical trials in order to develop new, better ways to treat people and to improve the health of individuals with specific medical conditions, but, in any clinical trial, the health of the volunteers is paramount.

Every clinical trial is different and has its protocol (description of the study), with its own set of research objectives, inclusion/exclusion criteria, and team of investigators. However, all clinical trials are subject to the same stringent rules and regulations that govern research that involves humans. Prior to the start of the project, the proposal has been reviewed by various committees within the hospital, including the Institutional Review Board, an interdisciplinary committee which evaluates all research to be sure that it meets the highest medical, as well as moral, ethical and legal standards.

There are many different types of clinical trials, such as treatment trials (which might evaluate new drugs, or new approaches to surgery therapy), prevention trials (which look for better ways to prevent disease), diagnostic trials (to find better tests to diagnose illness), screening trials (to better screen for health conditions), and quality-of-life trials (which investigate ways to improve the life of persons with a chronic illness). Researchers whose trial focuses on "outcomes" are looking at the way a service is delivered in order to see if there is a better way to provide patient care. "Validation studies" test the precision of performance measurements so that investigators are sure the instruments they use in gauging patients’ progress are accurate.