Useful Clinical Trial Terms
Adjuvant Therapy – Therapy provided to enhance the effect of a primary therapy; auxiliary therapy.
Adverse Effect – An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy).
Assent – Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.
Assurance – A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved.
Blinded studies – Usually a doctor, this is the individual who directs the clinical trial and is responsible for directing your study.
Clinical Research Coordinator – A nurse or other health care professional who assists the principal investigator in conducting the trial.
Clinical trial – A scientific study that tests the effectiveness of a new medical treatment, drug or device in patients and volunteers.
Double-blinded trials – Neither participants nor the investigators know to which group the participant has been assigned until the conclusion of the study.
Full board review – Review of proposed research at a convened meeting at which a majority of the membership of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting.
Gene therapy – The treatment of genetic disease accomplished by altering the genetic structure of either somatic (nonreproductive) or germline (reproductive) cells.
Human subject (participant) – A human subject is a volunteer participant in a research study. Any person who enrolls in a research study is known as a human subject (participant). Under the federal regulations, human subjects are defined as: living individual(s) about whom an investigator conducting research obtains: 1) data through intervention or interaction with the individual or 2) identifiable private information.
Informed Consent – The complete and open discussion of a clinical trial between the investigator(s) or research team member(s) and the patient/volunteer, during which all benefits, risks, procedures and expectations are explained. The FDA requires that this must occur before a patient/volunteer signs an informed consent form agreeing to participate in the trial.
Institutional Review Board (IRB) – Also known as Human Investigations Committee (HIC) – a committee of health care professionals and local citizens that monitors all clinical research trials being conducted in an institution. Protecting the safety and rights of participants is the primary purpose of this group.
Longitudinal study – A study designed to follow subjects forward through time.
Minimal risk – A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.
Open Label Study – A trial in which treatment is known to both the subject and investigator(s).
Placebo – An inactive form of treatment that has no effect, sometimes called a "sugar pill."
Protocol – The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s) and the proposed methods of analysis that will be performed on the collected data.
Randomization – Assignment of subjects to different treatments, interventions or conditions according to chance rather than systematically (e.g., as dictated by the standard or usual response to their condition, history, or prognosis, or according to demographic characteristics).
Research Assistant – A nurse or other health care professional who assists the clinical investigator(s) and coordinator(s) in running a trial.
Sponsor – Usually a pharmaceutical, drug or medical device company that wishes to investigate the effectiveness of a new product and financially supports the investigation.
Standard Treatment – Any treatment for a disease or condition that is currently in wide use and approved by the FDA. Clinical trials compare a new treatment to the standard treatment. If no prior treatment exists, a clinical trial will regard the lack of any treatment as the standard treatment.
Subject – The patient/volunteer who participates in a trial.
Therapy – Treatment intended and expected to alleviate a disease or disorder.
Voluntary – Free of coercion, duress or undue inducement. Used in the research context to refer to a subject's decision to participate (or to continue to participate) in a research activity.