Could an Open-Source Clinical Trial Data-Management System Be What We Have All Been Looking For?

摘要

In Europe, it is a legal requirement to conduct clinical trials in accordance with the International Conference on Harmonisation's guidelines on good clinical practice (see http://www.ich.org/). A recent editorial reported that this directive has led to a decline in the number of trials being conducted by independent academic groups [1]. One possible reason for this is that reporting and documentation requirements are now so burdensome that the process has become unnecessarily complicated [2]. This is rather ironic, given that well-designed clinical trials should be amenable to very simple data handling and analysis [3]. Indeed the flowchart established by the CONSORT (Consolidated Standards of Reporting Trials) statement [4] for carrying out a properly randomised controlled trial has just four steps, which supports the approach of keeping it simple.