The World Health Organization has called for the disclosure of all results from the clinical trials of new medicines, regardless of their success, to increase transparency in the drug innovation process.
The move follows the publication of several scientific studies showing that the results of many clinical trials are never published, especially if they fail to demonstrate that a medicine has a beneficial impact. This leads to money being wasted through research duplication, supporters of the initiative say.
Vasee Moorthy, coordinator of the WHO initiative and joint author of an article on the rationale behind the call published in PLOS Medicine last week (14 April), says researchers have a “social, scientific and ethical obligation” to publish all the results of clinical trials. Lack of access to clinical trials data can hinder the development of drugs and vaccines in and for developing countries, as trials of the same compounds have to start from scratch and thus become more costly.
A 2014 study in the British Medical Journal looked at randomised controlled trials of vaccines and showed that only 29 per cent of trials had been published in a peer-reviewed journal after two years, and 16 per cent were never reported. Furthermore, none of the trial administrators were fined, despite the US Food and Drug Administration being entitled since November to issue fines of US$10,000 dollars a day for non-reporting of results.
Such non-reporting causes delay in developing drugs and vaccines and affects decision making on international health interventions, Moorthy says. The April statement is not the WHO’s first on this topic: it issued a similar call ten years ago, which resulted in the creation of its International Clinical Trials Registry Platform. But this initiative remains voluntary, and registered firms are not obliged to publish data after clinical trials are completed.