Glossary of Common Terms Used in Clinical Trials
Baseline - An important study visit when a patient's vital signs and clinical symptoms are documented. The initial batch of study medication is usually dispensed during this visit and the patient's response is compared back to baseline over time.
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Blinding - The process through which one or more parties to a clinical trial are unaware of the treatment assignments. In a single-blinded study, usually the subjects are unaware of the treatment assignments. In a double-blinded study, both the subjects and the investigators are unaware of the treatment assignments. Also, in a double-blinded study, the monitors and sometimes the data analysts are unaware. "Blinded" studies are conducted to prevent the unintentional biases that can affect subject data when treatment assignments are known.
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Clinical Investigation - A systematic study designed to evaluate a product (drug, device, or biologic) using human subjects, in the treatment, prevention, or diagnosis of a disease or condition, as determined by the products benefits relative to its risks. Clinical investigations can only be conducted with the approval of the Food and Drug Administration (FDA).
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Clinical Trial - Any investigation in human subjects intended to determine the clinical pharmacological, pharmacokinetic, and/or other pharmacodynamic effects of an investigational agent, and/or to identify any adverse reactions to an investigational agent to assess the agent's safety and efficacy.
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Clinical Trial Site - The facility where the trial is being conducted. It can be a physician's private practice, a center dedicated solely to clinical research, or a hospital setting.
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Contract Research Organization (CRO) - A clinical services company involved with various steps in the clinical trial process from study design to trial execution and data management.
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Control Group - The comparison group of subjects who are not treated with the investigational agent. The subjects in this group may receive no therapy, a different therapy, or a placebo.
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Device - An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part of an accessory, which is intended for use in the diagnosis, cure, treatment or prevention of disease. A device does not achieve its intended purpose through chemical action in the body and is not dependent upon being metabolized to achieve its purpose.
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Double-Blind Trial - Many clinical trials are double blind in design. This means that neither patients nor investigators/doctors know whether an individual participant is on an active drug or a placebo.
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FDA (Food & Drug Administration) - The U.S Food and Drug Administration (FDA) is the federal agency responsible for ensuring that drugs, biological products, and medical devices are safe and effective for the general public. The FDA reviews and oversees the manufacturing specifications of these products, as well as the execution of clinical trials in which these products are evaluated. The agency also ensures that these products, once made commercially available, are represented in an accurate and informative manner.
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Inclusion/Exclusion Criteria - Inclusion/Exclusion Criteria is an actual section of a clinical trial protocol that lists specific medications, conditions and relevant medical information that may, or may not, be allowable during a trial. Age, blood pressure, and previously taken medications are a few examples of patient-specific information that would be compared to the inclusion/exclusion criteria of a protocol to determine eligibility.
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Informed Consent Form - A document created by the drug manufacturer (with the FDA's guidance) that outlines a patient's rights during participation in a clinical trial. It also discusses the potential risks and benefits associated with participation, including all available data on previous studies. An Informed Consent form must be signed by the patient or authorized caregiver before entrance into a study.
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Institutional Review Board - An Institutional Review Board (IRB) is an independent committee, comprised of individuals with diverse medical and non-medical backgrounds, that reviews and approves all study-related documents. An IRB approves protocols, Informed Consent forms, physician credentials and eligibility, and patient recruitment materials, such as print advertisements and public service announcements. IRBs work closely with the Food and Drug Administration to ensure that patient safety is the number one priority in a clinical trial.
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Open-label Trial - Later-phase studies (Phases III-IV) often have an open-label design, meaning that all patients receive active study medication --no placebo is dispensed.
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Placebo - A substance containing no active ingredients and having no pharmacological effects. Clinical trials often compare an investigational medication to a placebo in order to differentiate patient response.
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Principal Investigator (PI) - The lead doctor in charge of the execution of a clinical trial. As part of the site selection process, the PI's academic credentials and area(s) of expertise are evaluated.
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Protocol - A set of guidelines that must be followed during a clinical trial. It includes information on patient eligibility, data to be collected during patient visits, and included and excluded medical conditions and medications, to name a few.
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Randomization - The assignment of individuals to treatment groups in such a way that each individual in a clinical trial has an equal chance to be assigned to each treatment group. (Also see Double-Blind Trial)
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Study Coordinator - A key member of the clinical team who works directly for the principal investigator. Responsibilities usually include maintaining accurate patient documentation, dispensing medication, and general patient correspondence.
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