Adverse Event (AE)
A negative response experienced by an individual during the course of a clinical trial that is associated with the drug or study procedure.
The process through which the physician, research staff and subject are purposefully made unaware of the clinical research treatment assignments. In a single-blinded study, usually the subjects are purposefully unaware of the treatment assignments. In a double-blinded study, both the subjects and the investigators are purposefully unaware of the treatment assignments. Blinded studies are conducted to prevent the unintentional biases that can affect research data.
A clinical study designed to evaluate a drug using human subjects, in the treatment, prevention, or diagnosis of a disease, as determined by the product's benefits relative to its risks. Clinical investigations can only be conducted with the review and approval of the Food and Drug Administration (FDA).
Study of drug, biologic or device in human subjects with the intent to discover potential beneficial effects and/or determine the safety and efficacy of the study product.
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.
A document explaining all relevant study information to assist the potential study participant in understanding the expectations and requirements of participation in a clinical trial. This document is presented by the clinical research coordinator or investigating physician and signed by the study subject.
As defined by the Food, Drug and Cosmetic Act, drugs are "articles (other than food) intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, or to affect the structure or any function of the body of man or other animals."
A drug or device's ability to produce beneficial effects on the course of a disease. Efficacy is measured by evaluating the clinical and statistical data.
The characteristics that would prevent a subject from participating in a clinical trial, as outlined in the study protocol.
Food and Drug Administration (FDA)
Within the Department of Health and Human Services. Enforces Food, Drug and Cosmetics Act and related federal public health laws. Grants IND, IDE, PMA and NDA approvals.
Good Clinical Practice (GCP)
International ethical and scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting studies. Ensures that the data reported is credible and accurate, and that subject's rights and confidentiality are protected.
An individual participating in a research study.
A list of criteria that must be met by all study subjects.
The process during which a patient is informed of the details of the clinical research trial including risks, benefits, study design and patient responsibilities. Patients who agree to participate in the research study are asked to give their consent by signing this document. Patients will be given a copy of the fully executed document for their records.
Institutional Review Board (IRB)
An group of professionals designated to review and approve the clinical protocol previously approved by the FDA and any other documentation associated with the research study to ensure that the study is safe and effective for human participation. It is also the responsibility of the IRB to ensure that the study adheres to the FDA's regulations.
A medical professional under whose direction an investigational drug is prescribed and administered. A principal investigator is responsible for the overall conduct of the clinical trial of the site.
Phase I Study
Phase I studies are designed to establish how a new drug affects humans. These studies are usually conducted on small populations of healthy research study participants to specifically determine a drug's toxicity, absorption, distribution and metabolism.
Phase II Study
Phase II studies are designed to test a drug 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
Phase III studies are conducted on large populations of patients. Phase III studies usually test the new drug in comparison with the standard therapy currently being used for the disease being studied.
Phase IV Study
Phase IV studies are conducted after FDA approval to compare the drug to a competitor, in additional patient populations, or to further study any adverse events.
An benign substance designed to resemble the drug being tested. It is used as a control to rule out any bias. Most well-designed studies include a control group which is unwittingly taking a placebo.
A written plan that details the objectives, study design, and methodology for a clinical trial. A study protocol must be approved by the FDA and an IRB before investigational drugs may be administered to humans.
Randomization ensures that no specific criteria are used to assign any patients to a particular group, all the groups will be equally comparable.
Serious Adverse Event (SAE)
Any adverse event (AE) that is fatal, life-threatening, permanently disabling, or which results in hospitalization, initial or prolonged.
The pharmaceutical entity taking responsibility for initiation, management and financing of study.
A medical professional that assists the Investigator in the study activities at a study site.
Subject / Study Subject
Participant in a clinical research study. See Human Subject