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.
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 .
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.
Ideally, such a system would work as well for a single-centred investigator-led small trial as it would for large regulatory standard multi-centred randomised controlled trials. Furthermore, this system would need to be affordable to the public sector and modifiable and amenable for use with existing software already employed, particularly statistical and reporting software. This is quite a tall order. Put in this context, and considering the dialogue between research groups on this matter, it would seem prudent for international health research organisations to combine their efforts and spending power and assist with the development of systems that are open to all and truly fit for purpose. The daunting challenges of capturing, cleaning, extracting, and storing trial data would then be eased, with the added desirable benefit of improving quality and reliability of data. Perhaps we would then see more academics wanting to conduct clinical research.