study design


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study design

A plan that delineates the precise procedures to be followed in a clinical trial, including planned and actual timing of events, choice of control group, method of allocating treatments and blinding methods. The study design assigns a subject/patient to one or more epochs during the trial.

Examples
Crossover, dose-escalation, parallel.
References in periodicals archive ?
Tenders are invited for Study, design transformation and renovation of the building located rue Neuve 108-6061 Montignies-sur-Sambre (lot 3) - study design, demolition and reconstruction of buildings on Avenue of Europe and 16 rue de la Broucheterre 169-6000 Charleroi (lots 1 and 4) and study, partial demolition and partial renovation (lot 2) Deadline for receipt of tenders or requests to participate: 19.
Epidemiology: Study Design and Data Analysis, 3rd Edition
Bland reviewed the study design of 98 clinical trials involving natural supplements published in top-ranked, peer-reviewed medical journals.
1) A commentary on a systematic review of study design, quality and accuracy in liquid-based versus conventional cervical screening (2) cautions against allowing enthusiasm for new technology to replace proper study design.
Overall, the trend toward a more rigorous study design appears healthy, and heightened awareness of the strengths and weaknesses of the study design of each published paper is certainly advantageous to physicians and our patients.
The study design must control for confounders by matching the groups at inclusion or by adjustment.
The CDER guidance agenda includes "How to Comply With the Pediatric Research Equity Act," "Clinical Lactation Studies: Study Design, Data Analysis, and Recommendations for Labeling" and Pharmacokinetics in Pregnancy: Study Design, Data Analysis, and Impact on Dosing and Labeling.
once the study design is determined, the gathering and analysis of data proceed rapidly.
Significant areas of difference in outcomes assessment include study design, types of outcomes studied, information regarding patients prior to interventions, periods of patient follow-up after interventions, and sources of data.
Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines" to their offering.
Class IV includes any study design in which the test under investigation is not applied in a blinded evaluation, or in which evidence is provided by descriptive case series without controls or by expert opinion alone.

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