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Activity Number: 617 - Indirect Comparisons of Treatment Effects for Clinical Regulatory and Health Economic Evaluations
Type: Topic Contributed
Date/Time: Thursday, August 2, 2018 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #330798 Presentation
Title: Inference for Clinical Trials That Rely on Historical Data: a Review of Statistical Approaches for Reducing Risk of Bias
Author(s): Lei Nie and James Signorovitch and Rajeev Ayyagari*
Companies: Division of Biometrics V, office of Biostatistics, CDER/FDA and Analysis Group and Analysis Group
Keywords: indirect comparison; historical trials; single arm trials; clinical trials

According to the code of federal regulation , clinical investigations of a drug distinguish the effect of a drug from other influences through adequate and well-controlled clinical investigation. Randomized, double blind, placebo or active controlled trials are the gold standard. However, due to ethical concern or infeasibility, non-inferiority trials or single arm historical controlled trials are conducted. Inferences from these trials involve historical trials which could be substantially different from non-inferiority trials or single arm historical controlled trials, leading to potentially biased assessment therefore inadequate conclusions. In the presentation, we review statistical approaches developed to reduce the bias.

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

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