DESIGNING THE NEXT TRIAL FROM NETWORK META-ANALYSES USING SIMULATION-BASED ASSURANCE CALCULATIONS
Author(s)
Owen R1, Welton N2, Abrams KR1
1University of Leicester, Leicester, UK, 2University of Bristol, Bristol, UK
OBJECTIVES: Differences in the quality and design of published trials make it difficult to recognise when the amassing evidence can be considered sufficient for healthcare decision-making. The power of new evidence to shift the result of an existing meta-analysis in to statistical significance is known as ‘assurance’. We propose a flexible Bayesian framework to undertake evidence-based assurance calculations to appropriately design and power a new trial from meta-analyses. METHODS: Motivated by a recent network meta-analysis evaluating oral anticoagulants for the prevention of stroke in atrial fibrillation, we assessed the power of a new 4-arm trial to shift the result of an existing meta-analysis in to statistical significance for healthcare decision-making. Bayesian Markov Chain Monte Carlo (MCMC) simulation was used to synthesise existing trial data in meta-analyses. Posterior predictive distributions were obtained to predict the effect of a new trial with disparate sample sizes. Simulated event data for a new trial were combined with the original trial results in meta-analyses to calculate assurance. RESULTS: We developed and successfully implemented a flexible Bayesian framework to perform evidence-based assurance calculations. For the prevention of stroke and systemic embolism, inclusion of new evidence had little power to shift the healthcare decision in to statistical significance. CONCLUSIONS: Inclusion of a future, large-scale trial evaluating oral anticoagulants on a head-to-head basis had little impact on the healthcare decision. If future healthcare decisions were to rely on meta-analysis results, it would appear that further trials in this area would not be justified. Evidence-based approaches should be considered in the design of future trials for healthcare interventions to avoid resource and research waste.
Conference/Value in Health Info
2019-11, ISPOR Europe 2019, Copenhagen, Denmark
Code
PCV117
Topic
Methodological & Statistical Research
Topic Subcategory
Modeling and simulation
Disease
Cardiovascular Disorders