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Activity Number: 20 - Statistical Considerations for Using Historical Controls in Clinical Trials
Type: Topic Contributed
Date/Time: Sunday, July 29, 2018 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #329294
Title: Using Historical Controls in CNS Clinical Trials
Author(s): Xiang Ling* and Kun Jin and Hsien-Ming James Hung, PhD
Companies: FDA/CDER/OTS/OB and FDA and Food and Drug Administration
Keywords: historical control

Historically controlled studies have been proposed in multiple disease areas in drug development programs. Due to the well-known limitations of historical controls, historical control designs are usually reserved for situations in which the endpoints are objective and prior belief of the drug effect is strong. In some circumstances, historical control designs are proposed because of ethical concerns or feasibility considerations for serious and rare conditions with unmet medical needs. In this presentation, we give a brief overview on the use of historical control designs in regulatory setting and the methodologies that are in statistical literature. Two neurologic drug development case examples will be shared. We will articulate the challenges in the statistical analyses and interpretation of a historical controlled trial. Various issues such as potential biases and homogeneity of the historical studies will be discussed.

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

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