Activity Number:
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293
- SPEED: Computing, Graphics, and Programming Statistics
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Type:
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Contributed
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Date/Time:
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Tuesday, August 1, 2017 : 8:30 AM to 10:20 AM
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Sponsor:
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Section for Statistical Programmers and Analysts
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Abstract #322479
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View Presentation
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Title:
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Maintaining Trial Integrity for Randomized Open-Label Trials
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Author(s):
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Wenyun Ji*
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Companies:
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Amgen, Inc.
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Keywords:
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oncology ;
clinical trials ;
statistical ;
programmer ;
CDISC ;
data analysis
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Abstract:
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Many oncology clinical trials are randomized open-label trials. In order to minimize operational bias while not hindering critical activities in order to ensure subject safety, data quality and protocol compliance, measures of trial integrity need to be put in place by restricting access to treatment information from certain personnel who conduct the clinical trials. This paper discusses three different ways that may be used by statistical programmers during the conduct of randomized open-label trials in order to maintain trial integrity. Statistical programmers must recognize the advantages and potential issues of each methodology and choose one that fits the purpose for their randomized open-label trials.
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Authors who are presenting talks have a * after their name.
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