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Information-adaptive clinical trials with selective recruitment and binary outcomes

Research output: Contribution to journalArticle

Original languageEnglish
Pages (from-to)2803-2813
Number of pages11
JournalStatistics in Medicine
Volume36
Issue number18
Early online date5 Jun 2017
DOIs
Accepted/In press26 Jan 2016
E-pub ahead of print5 Jun 2017
Published15 Aug 2017

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Abstract

Selective recruitment designs preferentially recruit individuals who are estimated to be statistically informative onto a clinical trial. Individuals who are expected to contribute less information have a lower probability of recruitment. Furthermore, in an information-adaptive design, recruits are allocated to treatment arms in a manner that maximises information gain. The informativeness of an individual depends on their covariate (or biomarker) values, and how information is defined is a critical element of information-adaptive designs. In this paper, we define and evaluate four different methods for quantifying statistical information. Using both experimental data and numerical simulations, we show that selective recruitment designs can offer a substantial increase in statistical power compared with randomised designs. In trials without selective recruitment, we find that allocating individuals to treatment arms according to information-adaptive protocols also leads to an increase in statistical power. Consequently, selective recruitment designs can potentially achieve successful trials using fewer recruits thereby offering economic and ethical advantages.

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