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  1. The FDA Science Forum

2023 FDA Science Forum

Considerations for open-label clinical trials: design, conduct, and analysis

Download the Poster (PDF; 0.32 MB)
Authors:
Poster Author(s)
Higgins, Karen, FDA/CDER/OTS/OB/DBIII; Gregory Levin, FDA/CDER/OTS/OB
Center:
Contributing Office
Center for Drug Evaluation and Research

Abstract

Poster Abstract

Randomization and blinding are regarded as the most important tools to help reduce bias in clinical trial designs. Randomization is used to help guarantee that treatment arms differ systematically only by treatment assignment at baseline, and blinding is used to ensure that during the trial the two arms are treated the same with differences only arising from the treatment received and not, for example, the expectation or desires of people involved. However, there are times when it is not feasible or ethical to conduct fully blinded trials. This poster reviews what can be done to improve the trial when fully blinding a trial is not considered possible.

Poster Image
Considerations for open-label clinical trials: design, conduct, and analysis

Download the Poster (PDF; 0.32 MB)

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