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Activity Number: 468 - Blinded Data Reviews Are Necessary in Today's Clinical Trials
Type: Topic Contributed
Date/Time: Wednesday, August 1, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #330736
Title: Tools and Techniques for Blinded Data Reviews in Ongoing Clinical Trials
Author(s): Suresh Ankolekar* and Hrishikesh Kulkarni
Companies: Cytel Inc. and Cytel Inc.
Keywords: blinded statistical analysis; time-to-event predictions; model and data validation

In this presentation, we focus on typical tools and techniques used for performing blinded data reviews from multiple perspectives in ongoing clinical trials. We cover application areas ranging from blinded statistical analysis to event milestones and timeline predictions. The iterative techniques include estimation of parameters for various distributional assumptions, simulation techniques for event prediction, and re-calibration of parameters to incorporate external inputs. We also briefly discuss the extensive validation techniques to detect model specification and data quality issues in time-to-event predictions. We illustrate the application of techniques using a standard commercial software product and relevant R packages. The illustrative examples are based on our practical experience in performing similar blinded data reviews in ongoing clinical trials.

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

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