Participants

Glossary

Blinded/Masking: Single-blind usually refers to you not knowing which treatment you will receive. Double-blind usually refers to you, your physician and perhaps others not knowing which treatment you will receive.

Clinical Research Coordinator (CRC): Site administer for the clinical study. Duties are delegated by the investigator. Also called research, study or healthcare coordinator, and data manager, research nurse or protocol nurse.

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.

Comparator: This can be an investigation or marketed product, or placebo. Investigational is the medication or placebo being tested or used in the study.

Consent Form: A document explaining all relevant study information to assist the study volunteer in understanding the expectations and requirements of participation in a clinical trial. This document is presented to and signed by the study subject.

Contract Research Organization (CRO): A person or an organization (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor's study-related duties and functions.

Control Group: A comparison group of study subjects who are not treated with the investigational agent. The subjects in this group may receive no therapy, a different therapy, or a placebo.

Effective Dose: The dose of an investigational agent that produces the outcome considered "effective," as defined in the study protocol. This could mean a cure of the disease in question or simply the mitigation of symptoms.

Efficacy: A product's ability to produce beneficial effects on the duration or course of a disease. Efficacy is measured by evaluating the clinical and statistical results of clinical tests.

Exclusion Criteria: Refers to the characteristics that would prevent a subject from participating in a clinical trial, as outlined in the study protocol.

Inclusion Criteria: A list of criteria that must be met by all subjects.

International Review Board (IRB): An independent group of professionals designated to review and approve the clinical protocol, informed consent forms, study advertisements, and patient brochures, to ensure that the study is safe and effective for human participation. It is also the IRB's responsibility to ensure that the study adheres to the FDA's regulations.

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.

Investigational Agent/Device: is a medication or device that has not ben approved for use by the Food and Drug Administration (FDA) to treat or diagnose a medical condition or illness.

Monitor: 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.

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 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 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 looks identical to the medication being studied and is assigned by chance or like a flip of the coin.

Protocol: A detailed plan that sets forth the objectives, study design, and methodology for a clinical trial. A study protocol must be approved by an IRB before investigational drugs may be administered to humans.

Randomization: Study participants are usually assigned to groups in such a way that each participant has an equal chance of being assigned to each treatment (or control) group. Since randomization ensures that no specific criteria are used to assign any patients to a particular group, all the groups will be equally comparable.

Recruitment: Act of enrolling subjects with the proper inclusion criteria.

Recruitment Period: Time allowed to recruit all subjects for a study.

Risk-Benefit Ratio: Risk to individual subject versus potential benefits. Also called Risk-Benefit Analysis.

Risk Factors: something which increases risk or susceptibility (www.dictionary.com)

Sponsor: Individual, company, institution or organization taking responsibility for initiation, management and financing of study.

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