Page 40 - Terminology-Clinical-Research

fewer than 5 in every 10,000 individuals in the EU) or for effect of a treatment on patients. Treatments may include
a disease not likely to generate sufficient profit to justify medications or other therapies and outcomes may include
Research and Development costs. changes in disease status, morbidity or mortality.

Orphan drug designation number: Designation of orphan Outliners: Values outside of an expected range.
drug status to drugs that are in the process of development
for the treatment of rare diseases. Overall survival (OS): The percentage of patients alive
at a defined period of time after diagnosis or, in treatment
Other adverse event: Identification numbers assigned to studies, the percentage of patients alive at a defined time
the clinical study protocol by the study sponsor, funders, or after initiation of the treatment. OS is often reported as a
others. These numbers include unique identifiers from other five-year survival rate, i.e. percentage of patients alive five
registries and National Institutes of Health grant numbers. years after diagnosis or treatment. The OS rates reported
after diagnosis of different diseases can vary, since some
Other descriptive name: Any other descriptive name for cancers have a better outlook (survival rate) than others.
an active substance. The effect of a treatment on OS should be viewed relative
to the background or expected OS for a given cancer. Note:
Other IDs: Identification numbers assigned to the clinical Important points to note about OS as an endpoint:
study protocol by the study sponsor, funders, or others.
These numbers include unique identifiers from other 1. OS is seen as the ‘Gold Standard’ clinical endpoint for
registries and National Institutes of Health grant numbers. many health authorities because it is a measure of survival.
2. However, measuring OS can be problematic when
Other study ID numbers: See Other IDs.
evaluating earlier lines of therapy (the line of therapy is
Outcome (of adverse event): Refers to the resolution the sequence of therapies a patient undergoes e.g. first-line
of an adverse event. Note: Often denoted using a pick is the initial treatment used to target tumors and will be
list from a controlled terminology such as: Recovered/ followed by a second-line treatment should the first line not
resolved, recovering/resolving, not recovered/not resolved, be effective). This is because measurement of OS is often
recovered/resolved with sequelae, fatal, or unknown. influenced by later lines of therapy making it difficult to
determine the true effect first-line treatment may have on
Outcome measures: A planned measurement described OS.
in the protocol that is used to determine the effect of
interventions on participants in a clinical trial. For
observational studies, a measurement or observation
that is used to describe patterns of diseases or traits, or P
associations with exposures, risk factors, or treatment.
Types of Outcome measures include Primary outcome
measure and Secondary outcome measure.

Outcome: 1. Events or experiences that clinicians or Packaging: The material, both physical and informational,
investigators examining the impact of an intervention that contains or accompanies a marketed or investigational
or exposure measure because they believe such events therapeutic agent once it is fully prepared for release to
or experiences may be influenced by the intervention patients and/or subjects in clinical trials.
or exposure. 2. (SDTM) The result of carrying out a Pairing: A method by which subjects are selected so that
mathematical or statistical procedure. Note: 1. Such events two subjects with similar characteristics (for example,
and experiences are called clinical outcomes independently weight, smoking habits) are assigned to a set, but one
of whether they are part of the original question/protocol of receives Treatment A and the other receives Treatment B.
the investigation.
Parallel design (Parallel study): Describes a clinical
Outcomes research: Research concerned with benefits, trial in which two or more groups of participants receive
financial costs, healthcare system usage, risks, and quality different interventions. For example, a two-arm parallel
of life as well as their relation to therapeutic interventions. design involves two groups of participants. One group
Note: Usually distinguished from research conducted solely receives drug A, and the other group receives drug B. So
to determine efficacy and safety.
during the trial, participants in one group receive drug A
Outcomes trial/study: An outcomes trial evaluates the “in parallel” to participants in the other group, who receive

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