Could an Open-Source Clinical Trial Data-Management System Be What We Have All Been Looking For?
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. One possible reason for this is that reporting and documentation requirements are now so burdensome that the process has become unnecessarily complicated. This is rather ironic, given that well-designed clinical trials should be amenable to very simple data handling and analysis. Indeed the flowchart established by the CONSORT (Consolidated Standards of Reporting Trials) statement for carrying out a properly randomized controlled trial has just four steps, which supports the approach of keeping it simple.