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

Salanti, Georgia; Nikolakopoulou, Adriani; Sutton, Alex J; Reichenbach, Stephan; Trelle, Sven; Naci, Huseyin; Egger, Matthias (2018). Planning a future randomized clinical trial based on a network of relevant past trials. Trials, 19(1), p. 365. BioMed Central 10.1186/s13063-018-2740-2

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine (ISPM)
04 Faculty of Medicine > Pre-clinic Human Medicine > Department of Clinical Research (DCR)
04 Faculty of Medicine > Department of Dermatology, Urology, Rheumatology, Nephrology, Osteoporosis (DURN) > Clinic of Rheumatology and Immunology

UniBE Contributor:

Salanti, Georgia, Nikolakopoulou, Adriani, Reichenbach, Stephan, Trelle, Sven, Egger, Matthias

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

1745-6215

Publisher:

BioMed Central

Language:

English

Submitter:

Tanya Karrer

Date Deposited:

19 Jul 2018 14:04

Last Modified:

20 Feb 2024 14:16

Publisher DOI:

10.1186/s13063-018-2740-2

PubMed ID:

29996869

Uncontrolled Keywords:

Conditional power Evidence synthesis Historical data Rheumatoid arthritis Sample size

BORIS DOI:

10.7892/boris.118763

URI:

https://boris.unibe.ch/id/eprint/118763

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