Following discussions with colleagues at various institutions (including Oxford University, the London School of Hygiene and Tropical Medicine, the International Aids Vaccine Initiative, and the Medical Research Councils of Uganda, South Africa, and the United Kingdom), one major difficulty comes up time after time: these, and many other, clinical trial groups do not have the skills or resources to establish and use software systems required to manage trial data in compliance with the International Conference on Harmonisation's guidelines. This situation is further exacerbated for non-commercial research groups based in developing countries, where basic information systems infrastructure and support tends to be even more limited [5].

There is little good independent information about what is available. Additionally, there is almost a complete absence of guidance from regulatory agencies such as the European Medicines Agency and United States Food and Drug Administration about how to evaluate the many competing systems available, and indeed what the actual requirements are for trials where the data will be needed for a regulatory submission. This is particularly important with respect to trials evaluating products for neglected diseases, which are often carried out by academic researchers and where the data would be needed to support a product license. The size of this issue can be somewhat ascertained from the results of a search that we did at the World Health Organization trials registration site (http://www.who.int/trialsearch/, accessed September 27, 2007): use of the term “Africa” returned 206 trials, and the term “Asia” returned 520.

The US National Institute of Health's National Cancer Institute has a wide-ranging, quickly evolving, and very open-source friendly [10] initiative called CaBIG (Cancer Biomedical Informatics Grid), which includes clinical trials management systems, amongst others (see [11]). One of the many projects involved in CaBIG, OpenClinica (http://www.openclinica.org/), has used CaBIG as a springboard to launch and maintain a free and open-source clinical trials data-management system. This software is entirely built using open and free systems and programming languages. Such a system might be the basis for creating a “forked” solution (see Box 1) to fit the needs of those working on diseases of poverty in developing countries. In line with Oliveira and Salgado [12], we believe that a web-based solution to the complexities of running trials (especially multi-centre ones) and processing data is appropriate, as it reflects the information and technology expertise available globally that could be better used to support those engaged in clinical research. Other advantages of web-based systems are that they support simultaneous data entry from multiple sites and run using standard web browsers. Web-based technologies are rapidly being adopted in countries such as Kenya, where we are based. Here, as in many developing countries, there is a newly educated generation including, but not limited to, skilled computer scientists and informaticians, who will not only be passive recipients of such software but also become the future architects, developers, and maintainers of such systems. Individual researchers in any organisation should be able to more readily make use of such systems through standard information technology support provided by their employing organisation or institution.

Research organisations and funders should combine efforts to produce an open-source solution for trial data management. A shared platform could then be easily established, and would bring wider benefits such as electronic submission to regulators, automated sharing of data, and contribution to important public databases such as pharmacovigilance and drug-monitoring registries.