Glossary- Clinical Trials Terminology – M to P

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Glossary- Clinical Trials Terminology – M to P

M

meta-analysis A statistical process for pooling data from many clinical trials and summarizing it through formal statistical means. Also called overview.

monitor Person employed by the sponsor or CRO who is responsible for determining that a trial 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 trial, assessing the conduct of trials, and assisting in data analysis, interpretation, and extrapolation. Monitors work with the clinical research coordinator to check all data and documentation from the trial.

monitoring report A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs

multicenter trial A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.


N

n-of-1 study A trial in an individual subject is administered a treatment repeatedly over  a number of episodes to establish the treatment’s effect in that person, often with experimental and control treatments randomized.

New Drug Application (NDA) An application to FDA for a license to market a new drug in the United States

null hypothesis A null hypothesis (for example, “subjects will experience no change in blood pressure as a result of
administration of the test product”) is used to rule out every possibility except the one the researcher is trying to prove, an assumption about a research population that may or may not be rejected as a result of testing. Used because most statistical methods are less able to prove something true than to provide strong evidence that it
is false


O

open label study A trial in which subjects and investigators know which product each subject is receiving; opposite of doubleblind study.


P

p value The lowest level of significance at which a given null hypothesis can be rejected; that is, the probability of
observing a result as extreme or more extreme than that observed if the null hypothesis is true.

parallel trial Volunteers are randomized to one of two differing treatment groups (usually medicine and placebo) and usually receive the assigned treatment during the entire trial. Also called parallel group trial, parallel design trial.

pharmacodynamics (PD) The branch of pharmacology that studies reactions between drugs and living structures, including the processes of bodily responses to pharmacological, biochemical, physiological, and therapeutic effects.

pharmacokinetics (PK) The study of the processes of bodily absorption, distribution, metabolism, and excretion
(ADME) of compounds and medicines

placebo A pharmaceutical preparation that contains no active agent. In blinded studies, it is generally made to look just like the active product.

postmarketing surveillance Ongoing safety monitoring of marketed drugs.

preclinical studies Animal studies that support Phase 1 safety and tolerance studies and must comply with good
laboratory practice (GLP). Data about a drug’s activities and effects in animals help establish boundaries for safe use of the drug in subsequent human testing (clinical studies or trials). Because many animals have much shorter life spans than humans, preclinical studies can provide valuable information about a drug’s possible toxic
effects over an animal’s life cycle and on its offspring.

protocol A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term “protocol” refers to protocol and protocol amendments.

protocol amendment A written description of a change(s) to or formal clarification of a protocol. (ICH)


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