Page 45 - Terminology-Clinical-Research

Posterior distribution: The outcome of Bayesian Preterm newborn infants: Subjects are not more than 37
statistical analysis. A probability distribution describing weeks from their conception.
how likely are different values of an outcome (e.g.,
treatment effect). It takes into account the belief before the Prevention trials: Conducted to find better ways to prevent
study (the prior distribution) and the observed data from the disease in people who have never had the disease or to
study. prevent a disease from returning. These approaches may
include medicines, vitamins, vaccines, minerals, or lifestyle
Postmarketing commitment (PMC): Studies and clinical changes.
trials that applicants have agreed to conduct, but that will
generally not be considered as meeting statutory purposes Previously treated patient (PTP): Patients who have been
(see postmarketing requirement) and so will not be previously treated for a disease
required.
Previously untreated patients (PUP): Patients who have
Postmarketing requirement (PMR): FDA-required not been previously treated for a disease.
postmarketing studies or clinical trials. [FDAAA; 21 CFR
Part 314, Subpart H; 21 CFR Part 601, Subpart E]. PRIM&R: Public Responsibility in Medicine and
Research.
Postmarketing surveillance: Ongoing safety monitoring
of marketed drugs. Primary completion date: The date on which the last
participant in a clinical study was examined or received

Post-trial treatment: Plans for treatment or care after the an intervention and that data for the Primary Outcome
subject has ended the participation in the trial, if not already Measure were collected. Whether the clinical study ended
provided in the protocol. according to the protocol or was terminated does not
affect this date. The “estimated primary completion date”
Pragmatic trial: Term used to describe a clinical study is the date that the researchers think will be the Primary
designed to examine the benefits of a product under real Completion Date for the study. The Primary Completion
world conditions. Date is the term used on ClinicalTrials.gov for “completion
date” as defined in Section 801 of the Food and Drug
Preamble: A section preceding the text of a final FDA Administration Amendments Act of 2007.
regulation published in the Federal Register. Note: “The
preamble is to contain a thorough and comprehensible Primary end point(s): The main result that is measured at
explanation of the reasons for the Commissioner’s decision the end of a study to see if a given treatment worked (e.g.,
on each issue” raised in comments submitted in response to the number of deaths or the difference in survival between
the proposed regulation. the treatment group and the control group). What the
primary endpoint will be is decided before the study begins.
Preclinical trials (studies): Animal studies that support
Phase 1 safety and tolerance studies and must comply with Primary objective: The primary objective(s) is the main
good laboratory practice (GLP). Note: Data about a drug’s question to be answered and drives any statistical planning
activities and effects in animals help establish boundaries for the trial (e.g., calculation of the sample size to provide
for safe use of the drug in subsequent human testing the appropriate power for statistical testing).
(clinical studies or trials).
Primary outcome measure: The planned Outcome
Pre-Market Approval Application: An application to Measure in the protocol that is the most important for
FDA for a license to market a new device in the United evaluating the effect of an intervention. Most clinical
States. studies have one Primary Outcome Measure, but some may
have more than one.
Pre-protocol analysis: An analysis of the subset of
participants from a randomized controlled trial who Primary purpose: The main reason for the clinical trial.
complied with the protocol sufficiently to ensure that their The types of Primary purposes are Treatment, prevention,
data would be likely to exhibit the effect of treatment. Diagnostic, Supportive care, Screening, Health services
This subset may be defined after considering exposure research, Basic science, and Other.
to treatment, availability of measurements, and absence
of major protocol deviations. The per-protocol analysis Primary variable: An outcome variable specified in
strategy may be subject to bias as the reasons for the protocol to be of greatest importance to the primary
noncompliance may be related to treatment. objective of the trial, usually the one used in the sample

TERMINOLOGY CLINICAL RESEARCH 45