Glossary of Clinical Research - T

T

• Test article

Any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the FD&C Act (21CFR50.3)

• Toxicity

An adverse effect produced by a drug that is detrimental to the participant's health. The level of toxicity associated with a drug will vary depending on the condition which the drug is used to treat. (NLM)

• Treatment effect

An effect attributed to a treatment in a clinical trial. In most clinical trials the treatment effect of interest is a comparison (or contrast) of two or more treatments. (ICH E9)

• Treatment emergent

An event that emerges during treatment having been absent pre-treatment, or worsens relative to the pre-treatment state. (ICH E9)

• Treatment IND

IND stands for Investigational New Drug application, which is part of the process to get approval from the FDA for marketing a new prescription drug in the U.S. It makes promising new drugs available to desperately ill participants as early in the drug development process as possible. Treatment INDs are made available to participants before general marketing begins, typically during Phase III studies. To be considered for a treatment IND a participant cannot be eligible to be in the definitive clinical trial. (NLM)

• Treatment trials

Refers to trials which test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy. (NLM)

• Trial Site

The location(s) where trial-related activities are actually conducted. (ICH E6)

• Trial statistician

A statistician who has a combination of education/training and experience sufficient to implement the principles in this guidance and who is responsible for the statistical aspects of the trial. (ICH E9)

• t-test

A statistical test that is used to find out if there is a real difference between the means (averages) of two different groups. It is sometimes used to see if there is a significant difference in response to treatment between groups in a clinical trial. (NCI)