Page 52 - Terminology-Clinical-Research

responsible for, the supervision of staff, including other typically means disappearance of tumors as measurable
research associates and trainees, at the discretion of the using medical imaging techniques (scanners/radiological
Principal Applicant. tests) and/or by measurements of pathological specimens
and samples (tissues, biopsies, blood etc.). 2. Partial
Research (social, cultural, environmental and response (PR): At least 30% reduction in size of all
population health): Research with the goal of improving measureable tumors. 3. Stable disease (SD) or No change
the health of the Canadian population, or of defined sub- (NC): Between a 30% reduction or < 25% increase in the
populations, through a better understanding of the ways size of all detectable tumors. The reason these ‘reductions’
in which social, cultural, environmental, occupational and or ‘increases’ are considered as ‘stable disease’ is because
economic factors determine health status. A CIHR theme. without treatment, it might be expected that many

existing tumors would continue to grow or spread, not
Research hypothesis: The proposition that a study sets out decrease in size or grow at a slower than expected rate. 4.
to support (or disprove); for example, “blood pressure will Progressive disease (PD): Patients or proportion of patients
be lowered by [specific endpoint] in subjects who receive with a ≥ 25% increase in size of tumors since previous
the test product.”
measurement. Unlike a CR, PR or SD, PD suggests that the
Researcher: Anyone who carries out research activities. cancer is advancing, not reducing or stabilizing.

Researcher (independent): An individual who: 1. is Responsible party: The Sponsor, Sponsor-Investigator,
autonomous regarding their research activities; and 2. or Sponsor-designated Principal Investigator who is
has an academic or research appointment which: a. must responsible for submitting information about a clinical
commence by the effective date of funding; and b. allows study to ClinicalTrials.gov and updating that information.
the individual to pursue the proposed research project, to
engage in independent research activities for the entire Result synopsis: The brief report prepared by
biostatisticians summarizing primary (and secondary)
duration of the funding, to supervise trainees, and to efficacy results and key demographic information.
publish the research results; and c. obliges the individual
to conform to institutional regulations concerning the Results database: A structured online system, such as the
conduct of research, the supervision of trainees, and the ClinicalTrials.gov results database, that provides the public
employment conditions of staff paid with CIHR funding. with access to registration and summary results information
for completed or terminated clinical studies. Note: The
Note: An individual who meets the above requirements but ClinicalTrials.gov results database became available in
is also a “trainee” as defined in this glossary, is considered September 2008. Older studies are unlikely to have results
an “independent researcher” by CIHR provided that: 1. the available in the database.
research proposal covers only areas of investigation for
which they are an independent researcher and not areas Results first received date: The date on which summary
of research in which they are a trainee; and 2. they can information about the results of a clinical study was first
demonstrate in their application to CIHR that they will submitted to the ClinicalTrials.gov results database.
have sufficient time to devote to the proposed research. In
these cases, the individual must attach a description of their Results submission: The process of submitting and
area of study to their application. updating summary information about the results of a
clinical study to a structured, publicly accessible, Web-
Response option: One of several choices to be available based results database, such as the ClinicalTrials.gov
for selection in response to a prompt, question or results database.
instruction (i.e., a stem) in a PRO item.
Retrospective study: A study in which investigators
Response rate: Response rate measures tumor size, usually select groups of patients that have already been treated and
using a scan or X-ray. It gives an indication of whether analyze data from the events experienced by these patients.
the tumor is responding to a treatment – if the tumor size These studies are subject to bias because investigators can
has shrunk, it is deemed that there has been a “response”. select patient groups with known outcomes.
There are different ways of determining response rate
and the internationally recognized RECIST (Response Retrospective: Capture of clinical trial data is retrospective
Evaluation Criteria In Solid Tumors) guidelines are often when it is recalled from memory rather than captured
used in clinical trials. Note: 1. Complete response (CR): contemporaneously in real-time. Note: Retrospective
Disappearance of all clinical evidence of disease. This capture is important in PROs because of “recall bias”

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