Online Program Home
  My Program

Abstract Details

Activity Number: 293 - SPEED: Computing, Graphics, and Programming Statistics
Type: Contributed
Date/Time: Tuesday, August 1, 2017 : 8:30 AM to 10:20 AM
Sponsor: Section for Statistical Programmers and Analysts
Abstract #322479 View Presentation
Title: Maintaining Trial Integrity for Randomized Open-Label Trials
Author(s): Wenyun Ji*
Companies: Amgen, Inc.
Keywords: oncology ; clinical trials ; statistical ; programmer ; CDISC ; data analysis

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.

Authors who are presenting talks have a * after their name.

Back to the full JSM 2017 program

Copyright © American Statistical Association