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Glossary

Blinding: A procedure in which one or more parties to the clinical trial (i.e., the subject/patient, investigator, and/or sponsor medical personnel) are kept unaware of the treatment assignment(s) of the clinical trial participants. Used to remove potential for study bias.

Certified Clinical Research Coordinator (CCRC): A research professional with greater than two years clinical research experience and with certification earned by passing required program and exam.

Clinical Trial: A research study designed to test the safety and/or effectiveness of drugs, devices, treatments, or preventive measures in humans.

Control Group: Study participants assigned to receive standard treatment.

Double Blind: Neither the subject nor the investigator is aware of which treatment the subject is receiving. A double-blind design is generally considered to provide the most reliable data from a clinical trial. This type of clinical trial, however, is usually more complicated to initiate and conduct than single-blind or open-label trails.

Efficacy: The ability to produce a desired favorable effect in treating or preventing the studied disease or condition. Phase II clinical trials gauge efficacy and Phase III trials confirm it. For a description of all the phases of a clinical trial, click here.

Exclusion Criteria: The characteristics that prevent a subject from participating in a clinical trial, as outlined in the study protocol. These criteria might include things such as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Every clinical trial has specific guidelines regarding participation.

Experimental Group: Study participants assigned to the experimental group receive the drug, device, treatment, or intervention under investigation. In some studies, all participants are in the experimental group where in others, participants are assigned to either an experimental group or to a control group.

FDA (Food and Drug Administration): The FDA is the U.S. government agency that enforces laws on the manufacturing, testing, and use of drugs and medical devices. The FDA must approve drugs and medical devices for marketing before they are made commercially available.

Inclusion Criteria: A list of criteria (such as disease type, age, gender, and previous treatment) that must be met by all study subjects. Every clinical trial has specific guidelines regarding participation.

Informed Consent: A participant’s agreement to be in a study after being fully informed about what participating will involve. Informed consent begins with a discussion between the researchers and the prospective participants. The discussion includes important information about the research study such as:

  • The purpose of the study
  • The procedures involved
  • The risks and benefits of participating
  • How long the study will last
  • How the participant’s confidentiality will be protected
  • The key contacts for the study
  • What will happen if the study causes harm to the participants
  • That participation is voluntary and participants are free to withdraw from the study at any time

Based on this discussion with the researcher, participants are asked to sign a consent form that includes this same important information in writing. Participants are encouraged to talk with their physician, family, and friends and to ask questions whenever they need more information before signing it. Once the form is signed, participants are given a copy of the signed consent form so that they can review it at any time. Informed consent is an ongoing process, continuing during and after the study.

Institutional Review Board (IRB): A committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects. In the United States, regulations from the Food and Drug Administration (FDA) and the Department of Health and Human Services (specifically, the Office for Human Research Protections) have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.

Investigational or Experimental Device: A medical device (such as an artificial heart valve or a screw used to hold bones together) that has not yet received approval from the U.S. Food and Drug Administration (FDA) for marketing.

Investigational or Experimental Drug: A drug that is not yet approved for marketing—so it is not commercially available.

Investigator: A medical professional, usually a physician (but may also be a nurse, pharmacist or other health care professional), under whose direction an investigational drug is administered or dispensed. A principal investigator is responsible for the overall conduct of the clinical trial at his/her site.

Monitor: A person employed by the sponsor or CRO who reviews study records to determine that a study is being conducted in accordance with the protocol. A monitor’s duties may include, but are not limited to, helping to plan and initiate a study, and assessing the conduct of studies. Monitors work with the clinical research coordinator to check all data and documentation from the study.

Multi-Center Clinical Trials: A clinical trial conducted according to a single study protocol and identical methods at more than one investigative site, and therefore, carried out by more than one investigator.

Office for Human Research Protection (OHRP): A federal government agency that issues Assurances and overseas compliance of regulatory guidelines by research institutions.

Open-Label Study: A study in which all parties (patient, physician, and study coordinator) are informed of the drug and dose being administered. In an open-label study, none of the participants are given placebos. These are usually conducted with Phase I & II studies.

Phase I Study: The first of four phases of clinical trials, Phase I studies are designed to establish the effects of a new drug in humans. These studies are usually conducted on small populations of healthy humans to specifically determine a drug’s toxicity, absorption, distribution, and metabolism.

Phase II Study: After the successful completion of Phase I trials, a drug is then tested for safety and efficacy in a slightly larger population of individuals who are afflicted with the disease or condition for which the drug was developed.

Phase IIa Study: Pilot clinical trials to evaluate efficacy (and safety) in selected populations of subjects with the disease or condition to be treated, diagnosed, or prevented. Objectives may focus on dose-response, type of subject, frequency of dosing, or numerous other characteristics of safety and efficacy.

Phase IIb Study: Well-controlled trials to evaluate efficacy (and safety) in subjects with the disease or condition to be treated, diagnosed, or prevented. These clinical trials usually represent the most rigorous demonstration of a medicine’s efficacy.

Phase III Study: The third and last pre-approval round of testing of a drug is conducted on large populations of afflicted patients. Phase III studies usually test the new drug in comparison with the standard therapy currently being used for the disease in question. The results of these trials usually provide the information that is included in the package insert and labeling.

Phase IIIa Study: Trials conducted after efficacy of the medicine is demonstrated, but prior to regulatory submission of a New Drug/product Application (NDA) or other dossier. These clinical trials are conducted in subjects’ populations for which the medicine is eventually intended. Phase IIIa clinical trials generate additional data on both safety and efficacy in relatively large numbers of subjects in both controlled and uncontrolled trials. Clinical trials are also conducted in special groups of subjects (e.g. renal failure subjects) or under special conditions dictated by the nature of the medicine and disease. These trials often provide much of the information needed for the package insert and labeling of the medicine.

Phase IIIb Study: Clinical trials conducted after regulatory submission of an NDA or other dossier, but prior to the medicine’s approval and launch. These trials may supplement earlier trials, complete earlier trials, or may be directed towards new types of trials (e.g., quality of life, marketing) or Phase IV evaluations. This is the period between submission and approval of a regulatory dossier for marketing authorization.

Phase IV Study: After a drug has been approved by the FDA, Phase IV studies are conducted to compare the drug to a competitor, explore additional patient populations, or to further study any adverse events.

Placebo: An inactive substance that may look like medicine, but contains no medicine (i.e., a “sugar pill” with no treatment value). In some studies, the participants in a control group may be given a placebo.

Protocol: The formal design or action plan of a research study. A protocol is carefully designed to safeguard the health of the participants as well as answer specific research questions. The protocol explains what will be done, when, how, to whom, and why. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment. Every doctor/researcher and research facility involved in the clinical trial must follow the same protocol so that at the end of the study, information from all of the researchers can be combined and compared.

Randomization: The process of assigning trial participants to treatment or comparator groups based on chance in order to reduce potential bias. Typically, one group receives the experimental treatment, and the other group receives either the current standard treatment or a placebo. Participants should understand that they may or may not receive the new treatment. Randomized trials may be “blinded” or “double-blinded.” In a blinded trial, the participants do not know which treatment they will receive. In a double-blind trial, both the participants and the investigator/research staff do not know to which group participants have been assigned.

Single-Blind Study: A study in which one party, either the investigator or participant, is unaware of what medication the participant is taking; also called single-masked study.

Sponsor: An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.

Standard Treatment: A treatment currently in wide use and approved by the FDA, considered to be effective in the treatment of a specific disease or condition.

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