How to design a pre-specified statistical analysis approach to limit p-hacking in clinical trials: the Pre-SPEC framework

Kahan BC, Forbes G, Cro S.

This article describes a five-point framework (the Pre-SPEC framework) for designing a pre-specified analysis approach that does not allow p-hacking. The framework is based on the principles in the SPIRIT and ICH-E9 guidelines and is intended to be used in conjunction with these guidelines to help investigators design the statistical analysis strategy for the trial’s primary outcome in the trial protocol.