Quantitative liver function tests as surrogate markers for end‐points in controlled clinical trials: A retrospective feasibility study
E Lotterer, J Hogel, W Gaus, W E Fleig, J Bircher – 30 December 2003 – Quantitative liver function tests such as the determination of galactose elimination capacity (GEC) or the aminopyrine breath test (ABT) may have the potential to serve as refined entry criteria and surrogate markers for end‐points in controlled clinical trials. The magnitude of a statistically detectable difference in test results and the period of observation required to document such a difference must be known to properly design such trials.