Abstract

BackgroundThe important role of network meta-analysis of randomized clinical trials in health technology assessment and guideline development is increasingly recognized. This approach has the potential to obtain conclusive results earlier than with new standalone trials or conventional, pairwise meta-analyses.MethodsNetwork meta-analyses can also be used to plan future trials. We introduce a four-step framework that aims to identify the optimal design for a new trial that will update the existing evidence while minimizing the required sample size. The new trial designed within this framework does not need to include all competing interventions and comparisons of interest and can contribute direct and indirect evidence to the updated network meta-analysis. We present the method by virtually planning a new trial to compare biologics in rheumatoid arthritis and a new trial to compare two drugs for relapsing-remitting multiple sclerosis.ResultsA trial design based on updating the evidence from a network meta-analysis of relevant previous trials may require a considerably smaller sample size to reach the same conclusion compared with a trial designed and analyzed in isolation. Challenges of the approach include the complexity of the methodology and the need for a coherent network meta-analysis of previous trials with little heterogeneity.ConclusionsWhen used judiciously, conditional trial design could significantly reduce the required resources for a new study and prevent experimentation with an unnecessarily large number of participants.

Highlights

  • The important role of network meta-analysis of randomized clinical trials in health technology assessment and guideline development is increasingly recognized

  • We first consider the case of biologic and conventional disease-modifying anti-rheumatic drugs (DMARDs) for rheumatoid arthritis (RA)

  • Whether a biologic DMARD should be added to the initial therapy or whether initial therapy should be based on the less costly triple therapy of conventional DMARDS, i.e. methotrexate plus sulfasalazine plus hydroxychloroquine

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Summary

Introduction

The important role of network meta-analysis of randomized clinical trials in health technology assessment and guideline development is increasingly recognized. This approach has the potential to obtain conclusive results earlier than with new standalone trials or conventional, pairwise meta-analyses. Methods to synthesize evidence across trials of multiple comparisons, called network meta-analysis (NMA), have become more widely used [8]. Methods to plan a clinical trial to update a pairwise meta-analysis were proposed ten years ago [9,10,11] and recently have been extended to the setting of NMAs [12, 13]

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