Page 3 - Terminology-Clinical-Research

Activation: Enabling an eClinical trial system to capture
data; usually used for EDC (Electronic Data Capture)
A systems.
Active comparator arm: A group of participants that
receives an intervention that is considered to be effective.
One of several Arm types.
Abbreviation: A set of letters that are drawn from a word Active substance: An active substance (AS), is the
or from a sequence of words and that are used for brevity substance in a medicinal product that is biologically active.
in place of the full word or phrase. Note: An abbreviation
is not pronounced as a word, but each letter is read in Active, not recruiting: The clinical study is ongoing
sequence (e.g., NIH). (that is, participants are receiving an intervention or being
examined), but potential participants are not currently being
Absolute risk difference: The difference in size of risk recruited or enrolled. A type of Recruitment Status.
between two groups. For example, if one group has a 15%
risk of contracting a particular disease, and the other has a Adaptive licensing: Under adaptive licensing, the clinical-
10% risk of getting the disease, the risk difference is five development program is restructured to allow for early
percentage points. approval of a new compound for a limited, typically
high-risk population based on valid clinical measures from
Absolute risk reduction (ARR) and relative risk smaller human studies. Note: Approval would be revisited
reduction (RRR): 1. ARR is the absolute difference at several points along the clinical-development pathway as
between the number of events (e.g. percentage of patients candidate populations are broadened, longer-term outcomes
who have progressed) that occurred in the treatment group are evaluated, and risks of treatment are better understood.
and the number of those events in the control group. Note: Also called “staggered approval” and “progressive
For example, in a study where 10% of patients treated licensing”.
with drug A progressed vs. 15% of patients treated with
drug B there is a 5% ARR in disease progression with Adaptive pathways: The adaptive pathways approach is
drug A compared with drug B: ARR = 15% -10% = 5%. part of the European Medicines Agency’s (EMA) efforts
2. The RRR looks at that same difference between groups to improve timely access for patients to new medicines.
of patients given different treatments, but expresses the Adaptive pathways is a scientific concept for medicine
change in risk as a proportion, rather than an absolute development and data generation which allows for early
difference. Using the example above the RRR of and progressive patient access to a medicine. The approach
progression is reduced by 33% with Drug A compared with makes use of the existing European Union (EU) regulatory
Drug B: RRR = (15-10)/15 = 5/15 = 33.3%). framework for medicines. Adaptive pathways is based on
three principles: 1. Iterative development, which either
Absorption: The process by which medications reach the means: a. approval in stages, beginning with a restricted
blood stream when administered other than intravenously, patient population then expanding to wider patient
for example, through nasal membranes.
populations; b. confirming the benefit-risk balance of a
Accepts healthy volunteers: Indicates whether a clinical product, following a conditional approval based on early
study allows people who do not have the condition or data (using surrogate endpoints) considered predictive of
related conditions or symptoms being studied to participate important clinical outcomes; 2. Gathering evidence through
in that study. real-life use to supplement clinical trial data; 3. Early
involvement of patients and health-technology-assessment
Acronym: 1. A word formed from the beginning letters bodies in discussions on a medicine’s development.
(e.g., ANSI) or a combination of syllables and letters (e.g.,
MedDRA) of a name or phrase. 2. The short set of letters Adjusted analysis: An analysis that controls (adjusts) for
that identify a clinical study protocol. Note: An acronym is baseline imbalances in important patient characteristics.
usually pronounced as a word, not by speaking each letter Adjuvant: A treatment given in addition to the main
individually.
form of treatment (e.g. chemotherapy given in addition to
Action letter: An official communication from FDA to surgery) that aims to delay or prevent recurring disease by
an NDA (New Drug Application) sponsor announcing an destroying possible remaining cancer cells.
agency decision.

TERMINOLOGY CLINICAL RESEARCH 3