The World Health Organisation (WHO) issued a public statement in April calling for the disclosure of results from clinical trials for medical products, whatever the result. The move aims to ensure that decisions related to the safety and efficacy of vaccines, drugs and medical devices for use by populations are supported by the best available evidence.
Here below is the statement made by announcement made by the WHO on the this statement:
“Our intention is to promote the sharing of scientific knowledge in order to advance public health,” said Dr Marie-Paule Kieny, WHO Assistant Director-General for Health Systems and Innovation. “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,” said Dr Kieny. “It creates indirect costs for public and private entities, including patients themselves, who pay for suboptimal or harmful treatments.”
Unreported trials lead to misinformation
For example, 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. Among clinical trials of vaccines against 5 diseases registered in a variety of databases between 2006-2012, only 29% had been published in a peer-reviewed journal by the WHO recommended deadline of 24 months following study completion.
“We need the collaboration of all these actors to enforce transparency in their jurisdictions in order to increase the benefits and decrease the risks for patients, clinical trial volunteers and the general public,” concluded Dr Kieny.
International Clinical Trials Registry Platform furthers transparency
WHO’s call for disclosure includes older unreported clinical trials, the results of which may still have an important bearing on scientific research today. WHO also reaffirms the need for all clinical trials to be registered on a WHO primary clinical trial registry so that they can be accessible through the International Clinical Trials Registry platform. This will ensure transparency as to which clinical trials have occurred, and allow verification of compliance with public disclosure requirements.
The recent WHO move expands on a 2005 call for all clinical trials to be registered, and the subsequent establishment of the International Clinical Trials Registry Platform. This registry platform regularly imports trial records from ClinicalTrials.gov, ISRCTN registry, EU Clinical Trials Register, Australia New Zealand Clinical Trial Registry, Pan African Clinical Trial Registry and Clinical Trial Registries from China, India, Brazil, Republic of Korea, Cuba, Germany, Iran, Japan, Sri Lanka, The Netherlands and Thailand.
Publishing clinical trials results irrespectively of their outcome will help researchers to better understand the condition studied and what can be done to combat it. This is of particular relevance for rare diseases where patient populations are small and under-reported and where there is a constant lack of data on the condition and effective treatments. In the light of this, the European Haemophilia Consortium (EHC) has sent a letter to the manufacturers of all novel haemostatic products (both longer-acting and bypassing agents) to request systematic access to real-time safety related patient data from all ongoing clinical trials.