The World Health Organization is calling for all medical research involving humans to be registered at the earliest possible stage of its development. It is also calling for 20 key features of the research project to be made publicly available.
WHO made the recommendation as the world’s first international clinical trials day was held in Brussels on 19 May. Organised by the European clinical research infrastructures network, the European Commission, and WHO, the annual event is designed to raise general awareness about the methods and challenges of such research.
WHO’s proposal for voluntary registration is a response to demands for greater transparency and standardised information in tests for new forms of medical treatment, whether they involve patients or healthy volunteers.
Timothy Evans, assistant director general at WHO, explained that “registration of all clinical trials and full disclosure of key information at the time of registration are fundamental to ensuring transparency in medical research and fulfilling ethical responsibilities to patients and study participants.”
Currently there are several hundred registers of clinical trials worldwide. The aim of WHO’s “registry platform” is not to replace these but to establish a common set of standards and a global network with a single point of access for the information it contains. The internet based search portal that will make this possible will be launched later this year.
The need for more light to be shed on research was a strong theme at the inaugural international clinical trials day. Janez Potoènik, the European commissioner for science and research, emphasised the need for trust between the public and clinical trial practitioners and for protection of trial participants.
Iain Chalmers of the James Lind Library (www.jameslindlibrary.org), which aims to help people understand fair tests of treatments, described the greatest challenge in this area as “dealing with biased publication of research and vested interests.” He stressed the importance of better understanding among members of the public of how they can get reliable information on testing and for more discrimination when health claims are made.
The event brought together not only public health officials from across Europe and other countries but also regulators, academics, and representatives from patients’ organisations and the drug industry.
Participants underlined the need for systematic reviews of clinical trial results in a given field. As an example, Steff Lewis, of the Cochrane Collaboration, pointed out that by the early 1980s 23 trials on thrombolytic treatment in acute myocardial infarction had shown that active treatment was better than a placebo control. Despite this a further 47 trials took place in the next decade at great cost, depriving the 40 000 trial participants of active treatment.
In future years international clinical trials day will be held on 20 May, commemorating the day when the Scottish naval surgeon James Lind began his famous controlled trial of treatment for scurvy.