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Activity Number: 339 - SPEED: Biopharmaceutical and General Health Studies: Statistical Methods and Applications, Part 1
Type: Contributed
Date/Time: Tuesday, July 30, 2019 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #306723 Presentation
Title: Blinding in Open Label Study with Adaptive Design
Author(s): Bo Xu* and Bo Jin and Alex Dmitrienko
Companies: Boston Biomedical Inc and Boston Biomedical Inc and Mediana Inc
Keywords: blinding; open label study; adaptive design ; sample size re-estimation

Blinding or masking is intended to limit the occurrence of conscious and unconscious bias in the conduct and interpretation of a clinical trial. The double-blind trial is the optimal approach but it’s not always feasible. In the scenario of open label study is conducted, blinding to the sponsor will increase the integrity of the trials and reduce potential operational bias introduced by Sponsor knowing the aggregative results. A real case example will be introduced to see how to add blinding or masking from different perspectives. Operational wise, blinding maintenance plan is introduced to set up additional firewall between blinded or un-blinded study team member. Additional post randomization blinding in data base is setup as well to mimic double blinding trial operation to the blinded team member. In the case that Interim Analysis with adaptive design (sample size re-estimation) is conducted, additional steps to prevent back-calculation of the treatment effect is discussed.

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

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