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Published in: Trials 1/2018

Open Access 01-12-2018 | Methodology

Planning a future randomized clinical trial based on a network of relevant past trials

Authors: Georgia Salanti, Adriani Nikolakopoulou, Alex J. Sutton, Stephan Reichenbach, Sven Trelle, Huseyin Naci, Matthias Egger

Published in: Trials | Issue 1/2018

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Abstract

Background

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

Network 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.

Results

A 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.

Conclusions

When 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.
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Metadata
Title
Planning a future randomized clinical trial based on a network of relevant past trials
Authors
Georgia Salanti
Adriani Nikolakopoulou
Alex J. Sutton
Stephan Reichenbach
Sven Trelle
Huseyin Naci
Matthias Egger
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2740-2

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