End-points in clinical trials for liver cancer and their value in evidence based clinical decision making: an unresolved Gordian knot.

Design and execution of clinical trials use definitions and criteria to permit a homogeneous study development avoiding heterogeneous decisions by investigators at different sites. Ideally, definitions and decision making in clinical practice should mimic those implemented in trials, but this is not the case. Target population is narrowly defined in trials and the goal of them is the evaluation of activity and toxicity, and ultimately, the demonstration of a survival benefit. In practice, treated patients may not fit into the inclusion/exclusion criteria of the trial, the evaluation of activity may also differ and the common policy to stop therapy upon progression may not be followed if progression is minor.
Source: Journal of Hepatology - Category: Gastroenterology Authors: Tags: Expert Opinion Source Type: research