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-  2017 

Accelerating drug development for Alzheimer's disease through the use of data standards

DOI: 10.1016/j.trci.2017.03.006

Keywords: Regulatory science, Translational science, Data science, Drug development and Alzheimer's disease, Data standards, Clinical trials, CDISC, Mild cognitive impairment, Biomarkers, Clinical outcome assessments, Therapeutic Area User Guide

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Abstract:

The exceedingly high rate of failed trials in Alzheimer's disease (AD) calls for immediate attention to improve efficiencies and learning from past, ongoing, and future trials. Accurate, highly rigorous standardized data are at the core of meaningful scientific research. Data standards allow for proper integration of clinical data sets and represent the essential foundation for regulatory endorsement of drug development tools. Such tools increase the potential for success and accuracy of trial results

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