November 2007, Volume 4 Issue 5

Clinical Trial Terms You Should Know

Adverse Drug Reaction (ADR): An unwanted effect caused by the administration of drugs. Onset may be sudden or develop over time. In clinical trials, an ADR would include any injuries due to overdosing, abuse/dependence and unintended interactions with other medical treatments.

Blinding: The process through which one or more parties involved in a clinical trial are unaware of the treatment assignments. In a single-blinded study (also called a single-masked study), usually the volunteers are unaware of the treatment assignments. In a double-blinded study (double-masked study), both volunteers and the investigator are unaware of the treatment assignments. Also, in a double-blinded study, the monitors and sometimes the data analysts are unaware.

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.

Control group: A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo.

Food and Drug Administration (FDA): The U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices, including those used in the diagnosis, treatment, and prevention of HIV infection, AIDS, and AIDS-related opportunistic infections.

Inclusion/Exclusion Criteria: The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe.

Informed Consent: The process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study.

Informed Consent Document: A document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

Institutional Review Board (IRB): an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected.

Placebo: A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment’s effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or experimental treatment.

Protocol: A protocol is a study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. 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.

Risk-Benefit Ratio: The risk to individual participants versus the potential benefits. The risk/benefit ratio may differ depending on the condition being treated.

Standard Treatment: The currently accepted treatment or intervention considered to be effective in the treatment of a specific disease or condition.

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