How individual participant data meta-analyses have influenced trial design, conduct, and analysis

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• 作者：Jayne F. Tierney^a ; ^{jayne.tierney@ucl.ac.uk" class="auth_mail" title="E-mail the corresponding author} ; Jean-Pierre Pignon^b ; Francois Gueffyier^c ; ^d ; Mike Clarke^e ; Lisa Askie^f ; Claire L. Vale^a ; Sarah Burdett^a ; On behalf of the Cochrane IPD Meta-analysis Methods GroupP. Alderson ; L. Askie ; D. Bennett ; S. Burdett ; M. Clarke ; S. Dias ; J. Emberson ; F. Gueyffier ; A. Iorio ; M. Macleod ; B.W. Mol ; C. Moons ; M. Parmar ; R. Perera ; R. Phillips ; J.P. Pignon ; J. Rees ; H. Reitsma ; R. Riley ; M. Rovers ; L. Rydzewska ; C. Schmid ; S. Shepperd ; S. Stenning ; L. Stewart ; J. Tierney ; C. Tudur Smith ; C. Vale ; J. Welge ; I. White ; W. Whiteley
• 关键词：Individual participant data (IPD) ; Systematic review ; Meta-analysis ; Trial conduct ; Trial design ; Trial analysis
• 刊名：Journal of Clinical Epidemiology
• 出版年：2015
• 出版时间：November 2015
• 年：2015
• 卷：68
• 期：11
• 页码：1325-1335
• 全文大小：264 K

文摘

To demonstrate how individual participant data (IPD) meta-analyses have impacted directly on the design and conduct of trials and highlight other advantages IPD might offer.

Study Design and Setting

Potential examples of the impact of IPD meta-analyses on trials were identified at an international workshop, attended by individuals with experience in the conduct of IPD meta-analyses and knowledge of trials in their respective clinical areas. Experts in the field who did not attend were asked to provide any further examples. We then examined relevant trial protocols, publications, and Web sites to verify the impacts of the IPD meta-analyses. A subgroup of workshop attendees sought further examples and identified other aspects of trial design and conduct that may inform IPD meta-analyses.

Results

We identified 52 examples of IPD meta-analyses thought to have had a direct impact on the design or conduct of trials. After screening relevant trial protocols and publications, we identified 28 instances where IPD meta-analyses had clearly impacted on trials. They have influenced the selection of comparators and participants, sample size calculations, analysis and interpretation of subsequent trials, and the conduct and analysis of ongoing trials, sometimes in ways that would not possible with systematic reviews of aggregate data. We identified additional potential ways that IPD meta-analyses could be used to influence trials.

Conclusions

IPD meta-analysis could be better used to inform the design, conduct, analysis, and interpretation of trials.