Literature DB >> 30325059

Power priors based on multiple historical studies for binary outcomes.

Isaac Gravestock1, Leonhard Held1.   

Abstract

Incorporating historical information into the design and analysis of a new clinical trial has been the subject of much recent discussion. For example, in the context of clinical trials of antibiotics for drug resistant infections, where patients with specific infections can be difficult to recruit, there is often only limited and heterogeneous information available from the historical trials. To make the best use of the combined information at hand, we consider an approach based on the multiple power prior that allows the prior weight of each historical study to be chosen adaptively by empirical Bayes. This choice of weight has advantages in that it varies commensurably with differences in the historical and current data and can choose weights near 1 if the data from the corresponding historical study are similar enough to the data from the current study. Fully Bayesian approaches are also considered. The methods are applied to data from antibiotics trials. An analysis of the operating characteristics in a binomial setting shows that the proposed empirical Bayes adaptive method works well, compared to several alternative approaches, including the meta-analytic prior.
© 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Entities:  

Keywords:  clinical trials; empirical Bayes; historical controls; operating characteristics; power prior

Mesh:

Substances:

Year:  2018        PMID: 30325059     DOI: 10.1002/bimj.201700246

Source DB:  PubMed          Journal:  Biom J        ISSN: 0323-3847            Impact factor:   2.207


  3 in total

1.  Power gains by using external information in clinical trials are typically not possible when requiring strict type I error control.

Authors:  Annette Kopp-Schneider; Silvia Calderazzo; Manuel Wiesenfarth
Journal:  Biom J       Date:  2019-07-02       Impact factor: 2.207

2.  Incorporating historical controls in clinical trials with longitudinal outcomes using the modified power prior.

Authors:  Hongchao Qi; Dimitris Rizopoulos; Emmanuel Lesaffre; Joost van Rosmalen
Journal:  Pharm Stat       Date:  2022-02-06       Impact factor: 1.234

3.  Optimizing the Design and Analysis of Clinical Trials for Antibacterials Against Multidrug-resistant Organisms: A White Paper From COMBACTE's STAT-Net.

Authors:  Marlieke E A de Kraker; Harriet Sommer; Femke de Velde; Isaac Gravestock; Emmanuel Weiss; Alexandra McAleenan; Stavros Nikolakopoulos; Ohad Amit; Teri Ashton; Jan Beyersmann; Leonhard Held; Andrew M Lovering; Alasdair P MacGowan; Johan W Mouton; Jean-François Timsit; David Wilson; Martin Wolkewitz; Esther Bettiol; Aaron Dane; Stephan Harbarth
Journal:  Clin Infect Dis       Date:  2018-11-28       Impact factor: 9.079

  3 in total

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