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Selective recruitment designs preferentially recruit individuals that areestimated to be statistically informative onto a clinical trial. Individualsthat are expected to contribute less information have a lower probability ofrecruitment. Furthermore, in an information-adaptive design recruits areallocated to treatment arms in a manner that maximises information gain. Theinformativeness of an individual depends on their covariate (or biomarker)values and how information is defined is a critical element ofinformation-adaptive designs. In this paper we define and evaluate fourdifferent methods for quantifying statistical information. Using bothexperimental data and numerical simulations we show that selective recruitmentdesigns can offer a substantial increase in statistical power compared torandomised designs. In trials without selective recruitment we find thatallocating individuals to treatment arms according to information-adaptiveprotocols also leads to an increase in statistical power. Consequently,selective recruitment designs can potentially achieve successful trials usingfewer recruits thereby offering economic and ethical advantages.

Information-adaptive clinical trials with selective recruitment and binary outcomes