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Activity Number:
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154
- Integrating Real World Data with Clinical Trials: Opportunities and Challenges
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Type:
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Topic Contributed
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Date/Time:
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Tuesday, August 4, 2020 : 10:00 AM to 11:50 AM
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Sponsor:
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Caucus for Women in Statistics
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Abstract #310961
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Title:
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An Integrated Analysis of Randomized Clinical Trials and Real World Evidence Studies: Theory and Application
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Author(s):
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Xiaofei Wang* and Shu Yang
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Companies:
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Duke University and North Carolina State University
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Keywords:
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Integrated analysis ;
RCT;
RWE;
Calibration ;
Causal inference;
Inverse weighting
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Abstract:
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In this talk, we exploit the complementing features of randomized clinical trials (RCT) and real world evidence (RWE) to estimate the average treatment effect of the target population. We will review existing methods in conducting integrated analysis of the data from RCTs and RWEs. We will then discuss in detail new calibration weighting estimators that are able to calibrate the covariate information between RCTs and RWEs. We will briefly review asymptotic results under mild regularity conditions, and confirm the finite sample performances of the proposed estimators by simulation experiments. In a comparison of existing methods, we illustrate our proposed methods to estimate the effect of adjuvant chemotherapy in early-stage resected non–small-cell lung cancer integrating data from a RCT and a sample from the National Cancer Database.
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Authors who are presenting talks have a * after their name.
