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

被引:37
作者
Tierney, Jayne F. [1 ]
Pignon, Jean-Pierre [2 ]
Gueffyier, Francois [3 ,4 ]
Clarke, Mike [5 ]
Askie, Lisa [6 ]
Vale, Claire L. [1 ]
Burdett, Sarah [1 ]
机构
[1] UCL, MRC Clin Trials Unit, London WC2B 6NH, England
[2] LNCC Plateforme Metaanal Oncol, Serv Biostat & Epidemiol, Villejuif, France
[3] Univ Lyon 1, F-69365 Lyon 07, France
[4] Hosp Civils Lyon, Serv Pharmacol Clin, Bron, France
[5] Queens Univ Belfast, All Ireland Hub Trials Methodol Res, Belfast BT7 1NN, Antrim, North Ireland
[6] NHMRC Clin Trials Ctr, Camperdown, NSW 1450, Australia
基金
英国医学研究理事会;
关键词
Individual participant data (IPD); Systematic review; Meta-analysis; Trial conduct; Trial design; Trial analysis; CELL LUNG-CANCER; PROPHYLACTIC CRANIAL IRRADIATION; SYSTEMATIC REVIEWS; RANDOMIZED-TRIALS; ADJUVANT CHEMOTHERAPY; RADIATION-THERAPY; RELEVANT EVIDENCE; CLINICAL-TRIALS; PATIENT-LEVEL; PHASE-II;
D O I
10.1016/j.jclinepi.2015.05.024
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
Objectives: 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. Crown Copyright (C) 2015 Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
引用
收藏
页码:1325 / 1335
页数:11
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