The World Health Organisation (WHO) issued a public statement this month calling for the disclosure of results of clinical trials of medicinal products, whatever the result. Dr Marie-Paule Kieny, WHO Assistant Director General for Health Systems and Innovation stated “It underpins the principal goal of medical research: to serve the betterment of humanity. Failure to publicly disclose trial results engenders misinformation, leading to skewed priorities for both R&D and public health interventions”. In a study that analysed reporting from large clinical trials (more than 500 participants) registered on clinicaltrials.gov and completed by 2009, 23% had no results reported. These unreported trials included nearly 300,000 participants. In 2005, the WHO called for all clinical trials to be registered and this led to the establishment of the International Clinical Trials Registry Platform, which collates information on clinical trials that have been notified in a network of clinical trial registries such as the EU Clinical Trials Register.
The new EU Clinical Trials Regulation No. 536/2014, which was passed in April 2014, requires drug makers to publish clinical trial results. The European Medicines Agency (EMA) already hosts a trial database – the EU Clinical Trials Register – however, it has not yet decided how the additional information required by the new Clinical Trials Regulation will be made public.