Information-adaptive clinical trials with selective recruitment and binary outcomes

James E. Barrett*

*Corresponding author for this work

    Research output: Contribution to journalArticlepeer-review

    2 Citations (Scopus)
    137 Downloads (Pure)

    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.

    Original languageEnglish
    Pages (from-to)2803-2813
    Number of pages11
    JournalStatistics in Medicine
    Volume36
    Issue number18
    Early online date5 Jun 2017
    DOIs
    Publication statusPublished - 15 Aug 2017

    Keywords

    • adaptive clinical trials
    • logistic regression
    • optimal experimental design
    • selective recruitment

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