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

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CDISC SDTM General Observation Class TerminologyClinical Data Interchange Standards Consortium Terminology

Papers overview

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2017
2017
Series: Pragmatic trials and real world evidence: Paper 1. Introduction.
This is the introductory paper in a series of eight papers. In this series, we integrate the theoretical design options with the… Expand
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2017
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
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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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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
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2015
2015
Clinical trial design for rare cancers: why a less conventional route may be required.
Major recent advances in the diagnosis, treatment, prevention and screening of cancer have led to improvements in survival and… Expand
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Review
2015
Review
2015
Critical issues in cancer vaccine trial design.
As the clinical experience with cancer vaccines and cancer immunotherapy increases, there are important lessons that can be… Expand
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2014
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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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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