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CDISC Trial Design Class

Known as: TRIAL DESIGN 
This SDTM class describes the plan for the procedures to be followed in a clinical trial, including planned and actual timing of events, control… Expand
National Institutes of Health

Related topics

Related topics

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CDISC SDTM General Observation Class TerminologyClinical Data Interchange Standards Consortium Terminology

Papers overview

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Highly Cited
2017
Highly Cited
2017
Challenges in conducting clinical trials in nephrology: conclusions from a Kidney Disease—Improving Global Outcomes (KDIGO) Controversies Conference
Despite the high costs of treatment of people with kidney disease and associated comorbid conditions, the amount of reliable… Expand
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2016
2016
Fracture healing: a consensus report from the International Osteoporosis Foundation Fracture Working Group
SummaryWe used the RAND UCLA appropriateness method to decide appropriateness of use of osteoporosis medication after incident… Expand
2016
2016
How do you design randomised trials for smaller populations? A framework
How should we approach trial design when we can get some, but not all, of the way to the numbers required for a randomised phase… Expand
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2016
2016
Pragmatic trial design elements showed a different impact on trial interpretation and feasibility than explanatory elements.
OBJECTIVES To illustrate how pragmatic trial design elements or inserting explanatory trial elements in pragmatic trials affect… Expand
Review
2015
Review
2015
Ethical considerations for designing GBS maternal vaccine efficacy trials in low-middle income countries.
Many in the scientific community agree that a randomized, placebo-controlled trial would offer the most scientifically rigorous… Expand
Highly Cited
2014
Highly Cited
2014
Focal therapy in prostate cancer: international multidisciplinary consensus on trial design.
BACKGROUND Focal therapy has been introduced for the treatment of localised prostate cancer (PCa). To provide the necessary data… Expand
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Highly Cited
2014
Highly Cited
2014
Patient-centeredness in the design of clinical trials.
Evidence from clinical trials should contribute to informed decision making and a learning health care system. People frequently… Expand
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Review
2014
Review
2014
Predictors of outcome for patients with lung adenocarcinoma carrying the epidermal growth factor receptor mutation receiving 1st-line tyrosine kinase inhibitors: Sensitivity and meta-regression…
PURPOSE We performed a sensitivity and meta-regression analysis, cumulating all randomized trials exploring the benefit of… Expand
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2014
2014
Value of information analysis optimizing future trial design from a pilot study on catheter securement devices
Background: Value of information analysis has been proposed as an alternative to the standard hypothesis testing approach, which… Expand
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2014
2014
Clinical trial design in small cell lung cancer: surrogate end points and statistical evolution.
BACKGROUND Small-cell lung cancer (SCLC) is a disease for which few recent therapeutic advances have been achieved. SCLC trial… Expand
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