Date Published: March 4, 2008
Publisher: Public Library of Science
Author(s): Greg W Fegan, Trudie A Lang
Abstract: The authors argue that research organizations and funders should combine efforts to produce an open-source solution for trial data management.
Partial Text: 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 randomised controlled trial has just four steps, which supports the approach of keeping it simple.
It has been noted  that clinical trials–related software can be prohibitively expensive, especially for individual researchers, or groups based in developing countries. The two most commonly used packages , Oracle Corp’s Oracle Clinical (http://www.oracle.com/industries/life_sciences/oracle-clinical.html) and Phase Forward’s Clintrial (http://www.phaseforward.com/products/clinical/cdm/cis/), are both designed for use with commercial database systems. Investing in such systems would cost in the range of hundreds of thousands of dollars, depending on the size of the trial and number of licenses needed. Such costs would take up a disproportionate amount of a typical non-commercial trial budget, which is generally in the same order of magnitude as the cost of these systems, and must cover everything required by the trial. This leads many developing country institutions with the unenviable choice of either not being able to comply with international standards or having to send case report forms off-site for processing. This lamentable state of affairs has been acknowledged by some funding groups, such as the Gates Foundation–supported Malaria Clinical Trials Alliance , the European and Developing Countries Clinical Trials Partnership, and the African Malaria Network Trust; however, addressing the need for an affordable, easy-to-use clinical trial data-management system is currently beyond the scope and remit of the capacity-building activities being rolled out by such groups.
Cynthia Brandt and Prakash Nadkarni of the Yale Center for Medical Informatics, with their TrialDB system (http://ycmi.med.yale.edu/trialdb/), have championed a non-commercial approach since the 1990s . However, although their software is freely available, its use is targeted to either Oracle’s Database Management System or Microsoft’s SQL Server for case report form generation and data capture and management. Whilst this “free” system is a good starting point for those who may already have the appropriate licensing and expertise for the required commercial components, its use in resource-poor countries and by individual researchers is likely to be limited. However, it is not inconceivable that this application could be re-engineered to take advantage of the free (for non-commercial use) and open-source database systems such as MySQL (http://www.mysql.org/) and PostgreSQL (http://www.postgresql.org/). Such an initiative could be funded by international health agencies for minimal outlay. Just as funders of biomedical research are starting to require scientific output to be published in open-access journals, could they not require that the software used for the management of clinical trials also be open? Even for commercial research organisations, such an approach can only be to their longer-term benefit, given the likely savings they would incur due to reduced software costs.
We propose a commitment by the major international donor and implementing groups to encourage efforts to develop a free and open-source data-management system for clinical trials that adheres to evolving standards such as those set by CDISC (the Clinical Data Interchange Standards Consortium; http://www.cdisc.org). We believe that an open-source approach has the best chance of ensuring that all kinds of groups can be involved with the development of systems that have bearing on global public health.
Although we perceive the need for the above-advocated approach to be most profound in developing countries and for those researchers working on small-to-large multi-centre non-commercial projects, if implemented correctly, its impact surely can only be beneficial to all clinical researchers. There are many examples of how open-source approaches have been used to assist scientific and biomedical research. Indeed, one eminent proponent of the open-source approach has even gone so far as to claim that PERL (an open-source language) saved the human genome project . Another example that relates to medical research is Thomson International’s well-known and widely used EndNote referencing software, which now relies on a commercial licensing of the power of the open-source MySQL database system. A good mainstream example might also support our point. Most of us, each and every day, utilise Web sites driven by the open-source Apache web server, which is the most common web server and has had over 50% of market share since 1998 .