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International Journal of Clinical Oncology
Published in: International Journal of Clinical Oncology 3/2018

Open Access 01-06-2018 | Special Article

Meta-analysis of randomized clinical trials in the era of individual patient data sharing

Authors: Takuya Kawahara, Musashi Fukuda, Koji Oba, Junichi Sakamoto, Marc Buyse

Published in: International Journal of Clinical Oncology | Issue 3/2018

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Abstract

Background

Individual patient data (IPD) meta-analysis is considered to be a gold standard when the results of several randomized trials are combined. Recent initiatives on sharing IPD from clinical trials offer unprecedented opportunities for using such data in IPD meta-analyses.

Methods

First, we discuss the evidence generated and the benefits obtained by a long-established prospective IPD meta-analysis in early breast cancer. Next, we discuss a data-sharing system that has been adopted by several pharmaceutical sponsors. We review a number of retrospective IPD meta-analyses that have already been proposed using this data-sharing system. Finally, we discuss the role of data sharing in IPD meta-analysis in the future.

Results

Treatment effects can be more reliably estimated in both types of IPD meta-analyses than with summary statistics extracted from published papers. Specifically, with rich covariate information available on each patient, prognostic and predictive factors can be identified or confirmed. Also, when several endpoints are available, surrogate endpoints can be assessed statistically.

Conclusions

Although there are difficulties in conducting, analyzing, and interpreting retrospective IPD meta-analysis utilizing the currently available data-sharing systems, data sharing will play an important role in IPD meta-analysis in the future.
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Metadata
Title
Meta-analysis of randomized clinical trials in the era of individual patient data sharing
Authors
Takuya Kawahara
Musashi Fukuda
Koji Oba
Junichi Sakamoto
Marc Buyse
Publication date
01-06-2018
Publisher
Springer Japan
Published in
International Journal of Clinical Oncology / Issue 3/2018
Print ISSN: 1341-9625
Electronic ISSN: 1437-7772
DOI
https://doi.org/10.1007/s10147-018-1237-z

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