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PSI Conference 2018: Consistency of treatment effect across pre-specified subgroups – should we (and, if so, how?) adjust for biases?

05 June 2018

    A key step in the evaluation of any pivotal Ph III RCT is to make a risk-benefit assessment and identify the right patient population to treat. One common approach is to conduct an interaction test per subgroup factor, or to perform a global interaction test before any further exploration of the results. There are well-known statistical issues with such approaches. In recent years, various alternative approaches have been proposed, all essentially based on avoiding isolated assessment of subgroup factors (one per time), and instead opt for a more holistic view, borrowing information across subgroups, aiming for some shrinkage of point estimates. The underlying thinking is that the strongest observed effects are overestimated, so some bias adjustment is motivated. We present methods proposed in the literature (including Bayesian shrinkage and Bootstrap-based bias reduction); we discuss their assumptions and their plausibility; we also illustrate their operating characteristics using simulated data.

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