Page 38 - Terminology-Clinical-Research

to be solved by the experiment. 7. Proper preparations planning for the trial (e.g., calculation of the sample size
should be made and adequate facilities provided to protect to provide the appropriate power for statistical testing).
the experimental subject against even remote possibilities Secondary objectives are goals of a trial that will provide
of injury, disability, or death. 8. The experiment should further information on the use of the treatment.
be conducted only by scientifically qualified persons.
The highest degree of skill and care should be required Observation: 1. An assessment of patient condition or
through all stages of the experiment of those who conduct analysis of data collected on an individual patient or group
or engage in the experiment. 9. During the course of the of patients. 2. (SDTM) A discrete piece of information
experiment the human subject should be at liberty to bring collected during a study. Note: Observations (meaning 1)
the experiment to an end if he has reached the physical are required by protocol (e.g., require evaluation of patient
or mental state where continuation of the experiment or data by investigator/staff). Such planned observations
seems to him to be impossible. 10. During the course of are typically distinguished from anecdotal comments noted
the experiment the scientist in charge must be prepared to during a clinical trial (which qualify as observations under
terminate the experiment at any stage, if he has probable meaning 2).
cause to believe, in the exercise of the good faith, Observational study model (design): The general
superior skill and careful judgment required of him that a design of the strategy for identifying and following up
continuation of the experiment is likely to result in injury,
disability, or death to the experimental subject. with participants during Observational studies. Types of
Observational Study Models include Cohort, Case-control,
Nursing women: Clinical trial includes women subjects Case-only, Case-cross-over, Ecologic or community
who are breastfeeding. studies, Family-based, and Other.
Observational study: A clinical study in which
participants identified as belonging to study groups are
O assessed for biomedical or health outcomes. Participants
may receive diagnostic, therapeutic, or other types
of interventions, but the investigator does not assign
participants to specific interventions (as in an Interventional
study). A study type.
Objective measurement: A measurement of a
physiological or medical variable such as blood glucose Observer assessment: An assessment of patient condition
level that is obtained by a measuring device rather than a made by an observer (investigator, nurse, clinician, family
human judgment or assessment. member, etc.). Note: Distinguished from self-assessment.
The observer relies on his or her judgment to assess the
Objective of the trial: The goal intended to be attained by subject. An interviewer simply capturing subject self-
the Clinical Trial. See Objective. assessments is not making an observer assessment.

Objective response rate (ORR): Percentage of patients Odds ratio: The ratio of the odds of an event in one group
whose cancer shrinks (Partial response – PR) and/or to the odds of an event in another group. In studies of
disappears (Complete response – CR) after treatment. treatment effect, the odds in the treatment group are usually
Note: Important points to note about ORR as an endpoint: divided by the odds in the control group. An odds ratio of
1. ORR is a physical measurement of tumor size, and is one indicates no difference between comparison groups.
thought to be an indication of treatment effectiveness. 2. For undesirable outcomes an OR that is less than one
ORR can provide physicians with important information indicates that the intervention was effective in reducing the
on how a patient is reacting to a treatment. 3. ORR can be risk of that outcome. When the risk is small, odds ratios are
particularly important in certain cancer types, especially very similar to risk ratios.
those which cause disfiguring lesions e.g. basal cell
carcinoma, where extensive surgery may be used to remove Office for Human Research Protections (OHRP): The
lesions. Office for Human Research Protections (OHRP) supports,
strengthens and provides leadership to the nation’s system
Objective: The reason for performing a trial in terms of the for protecting volunteers in research that is conducted or
scientific questions to be answered by the analysis of data supported by the U.S. Department of Health and Human
collected during the trial. Note: The primary objective is Services (HHS). OHRP provides clarification and guidance
the main question to be answered and drives any statistical to research institutions, develops educational programs

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