Page 43 - Terminology-Clinical-Research

the subset of subjects who complied with the protocol researching, assessing and evaluating information from
sufficiently to ensure that these data would be likely to healthcare providers and patients on the adverse effects of
exhibit the effects of treatment according to the underlying medications, biological products, herbalism and traditional
scientific model. medicines with a view to identify new information about
hazards associated with medicines and preventing harm to
Personnel (research): Includes undergraduate and patients.
graduate students, postdoctoral fellows, research assistants,
research associates, technicians, programmers, analysts, Phase: One in a set of successive stages in a progression or
etc., who may contribute to the research activities of an sequence such as 1. a step in the progression of a therapy
independent researcher. from initial experimental use in humans to postmarket
evaluation. 2. a stage in the conduct of a clinical trial.
Pharmaceutical form: A dosage form is the physical form Note: Clinical trials are generally categorized into four
of a dose of medication, such as a capsule or injection. The (sometimes five) phases. A therapeutic intervention may be
route of administration is dependent on the dosage. evaluated in two or more phases simultaneously in different
trials, and some trials may overlap two different phases.
Pharmacodynamics: Branch of pharmacology that studies
reactions between drugs and living structures, including the Phase 0: First-in-human trials, in a small number of
physiological responses to pharmacological, biochemical, subjects, that are conducted before Phase 1 trials and are
physiological, and therapeutic agents. intended to assess new candidate therapeutic and imaging

agents. The study agent is administered at a low dose for
Pharmacoeconomics: Branch of economics that applies a limited time, and there is no therapeutic or diagnostic
cost-benefit, cost-utility, cost-minimization, and cost- intent. Note: FDA Guidance for Industry, Investigators,
effectiveness analyses to assess the utility of different
pharmaceutical products or to compare drug therapy to and Reviewers: Exploratory IND Studies, January 2006
other treatments. classifies such studies as Phase 1. Note: A Phase 0 study
might not include any drug delivery but may be an
Pharmacogenetic test: An assay intended to study exploration of human material from a study (e.g., tissue
interindividual variations in DNA sequence related to drug samples or biomarker determinations).
absorption and disposition or drug action.
Phase 1: The initial introduction of an investigational new
Pharmacogenetics: Study of the way drugs interact with drug into humans. Phase 1 studies are typically closely
genetic makeup or the study of genetic response to a drug. monitored and may be conducted in patients or normal
volunteer subjects. Note: These studies are designed to
Pharmacogenomic test: An assay intended to study determine the metabolism and pharmacologic actions
interindividual variations in whole genome or candidate of the drug in humans, the side effects associated with
gene maps, biomarkers, and alterations in gene expression increasing doses, and, if possible, to gain early evidence on
or inactivation that may be correlated with pharmacological effectiveness. During Phase 1, sufficient information about
function and therapeutic response. the drug’s pharmacokinetics and pharmacological effects
should be obtained to permit the design of well-controlled,
Pharmacogenomics: Science that examines inherited scientifically valid Phase 2 studies. The total number of
variations in genes that dictate drug response and explores subjects and patients included in Phase 1 studies varies with
the ways such variations can be used to predict whether a the drug, but is generally in the range of 20 to 80. Phase 1
person will respond favorably, adversely, or not at all to an studies also include studies of drug metabolism, structure–
investigational product. activity relationships, and mechanism of action in humans,
as well as studies in which investigational drugs are used as
Pharmacokinetics: Study of the processes of bodily research tools to explore biological phenomena or disease
absorption, distribution, metabolism, and excretion processes.
(ADME) of medicinal products.
Phase 2: Controlled clinical studies conducted to evaluate
Pharmacology: The study of how drugs interact with the effectiveness of the drug for a particular indication
living organisms to produce a change in function. or indications in patients with the disease or condition
Pharmacology deals with how drugs interact within under study and to determine the common short term side
biological systems to affect function.
effects and risks associated with the drug. Note: Phase 2
Pharmacovigilance: The science of collecting, monitoring, studies are typically well controlled, closely monitored, and

TERMINOLOGY CLINICAL RESEARCH 43