Abstract
BackgroundIndividual 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.MethodsFirst, 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.ResultsTreatment 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.ConclusionsAlthough 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.
Highlights
In 2009, a special issue of the International Journal of Clinical Oncology reviewed the implementation and limitations of the meta-analysis of randomized controlled trials (RCTs)
Of meta-analysis [1], implementation of the tabulated-data meta-analysis [2], additional contributions of individual patient data (IPD) meta-analysis [3], and the development of the statistical methods for performing Individual patient data (IPD) meta-analysis [4]. In these articles the benefits of IPD meta-analysis were discussed, and IPD meta-analysis was presented as a gold standard for conducting a quantitative review of evidence arising from randomized clinical trials
What kind of evidence can be obtained through the above prospective collaboration and preparation of the standardized data as indicated? As an example of prospective IPD meta-analysis, we introduce one of the results of the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) [22], which highlights a number of important components of prospective IPD meta-analysis
Summary
In 2009, a special issue of the International Journal of Clinical Oncology reviewed the implementation and limitations of the meta-analysis of randomized controlled trials (RCTs). The ICMJE decided that after 1 July 2018 all authors submitting a clinical trial study for publication have to agree to these data-sharing statements at the time of manuscript submission [15] In line with these policies, most pharmaceutical companies have launched data-sharing initiatives. An example of a retrospective IPD meta-analysis currently in progress is that of Schünemann et al who initially published the design of their research project using data obtained through CSDR [43] Subsequent to their previous study-level systematic review and meta-analysis to evaluate the role of parenteral anticoagulants in patients with cancer, the results of which suggest a survival benefit and a reduction in venous thromboembolism, these researchers are conducting an IPD meta-analysis to further investigate. Antiepileptic drug monotherapy for epilepsy: an overview of systematic reviews and network meta-analysis
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