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Drug Information: Drug Study Design Quiz
Terms in this set (37)
A systematic error in a study design or in the way study subjects are selected, measured, and analyzed that can lead incorrect findings
Systematic error in the estimate of effect due to procedures used to select subjects or factors that influence study participation or follow-up.
Resulting from errors in study design, implementation, or analysis by the investigator.
Occurs due to differences in assessing or analyzing outcomes by the researcher due to awareness of which participants received the active vs control interventions.
Occurs due to systematic differences in care between treatment groups or in exposure to factors other than the intervention
Caused by differential drop out of patients in treatment and control groups in a RCT
A factor in a study that is associated with both the exposure and the outcome.
A process by which all subjects are equally likely to be assigned to either the experimental or control group.
The use of a random number generator to allocate participants to study groups
Stratified randomization (stratification)
A randomization process that ensures balance of participants for predefined strata based on prognostic factors such as disease severity among the study groups
The process by which the investigator, subject, or both are not aware of which treatment is being given.
Patient is blinded, but not the investigator
Neither the subject or the investigator are aware of the identity of the intervention
Patients, investigators, and those monitoring study data are unaware of treatment allocations
All participants and investigators are aware of treatment allocation
When treatment schedules cannot be made identical, participants will take both treatment schedules (placebo + treatment).
An inert substance that is identical in appearance to the active treatment
The accepted, standard drug treatment for a particular disease
Use of historical data to serve as a control for a concurrent study
The extent to which the clinical outcome of interest in a study is caused by the treatment.
The extent to which the results of a study can be generalized to other populations or settings.
Observational Study Designs
Design that involves observations by the researcher regarding the interplay of the independent variable with the dependent variable.
Brief report of clinical characteristics or courcse from a single clinical subject or event without comparison.
A descriptive study that consists of a group of patients who have been diagnosed with the same condition or are following similar procedures over a period of time.
Case Control Study
Research design that compares the frequency of exposure among cases that experience an outcome event and controls who do not have the outcome event.
involves the evaluations of data with regards to past events or existing data to achieve the research objective
Cohort Study Design
Observational study wherein two groups, exposed and unexposed are followed over a period of time until the development of the outcome of interest.
Researchers collect the data after the study onset by following individuals over a period of time.
Cross-sectional Study Design
Study that examines population characteristics at a cross-section (one-point) in time.
Randomized Controlled Trial
An experiment that involves randomization of intervention(s) of two or more groups
designed to determine if one therapy is superior to another treatment or placebo
designed to determine if one intervention is not inferior to another active intervention
Research design that ensures that each subject receives all of the interventions based on a specified sequence of events.
Time needed for the outcomes of a previous treatment to dissipate prior to beginning another treatment.
outcomes that remain or linger after the first treatment phase in a crossover design.
a structured process for identifying and summarizing existing studies that address a specific question (summaries medical literature).
uses quantitative methods to synthesize evidence from studies identified in a systematic review
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