WHO calls for increased transparency in medical research
Note for the media
14 APRIL 2015 | GENEVA – WHO today issued a public statement 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.

“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.

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PATH [to 18 April 2015]
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Announcement – Posted April 14, 2015.
Statement from PATH in support of WHO call for public disclosure of clinical trial results
New guidelines part of a growing movement to increase transparency and availability of clinical trial results
PATH commends the World Health Organization (WHO) statement calling for greater transparency and public availability of clinical trial results. Issued today in Geneva, the statement seeks to improve the regularity and timeliness of results reporting and urges action across jurisdictions to enact policies that encourage increased results reporting. With this statement, WHO joins a growing list of donors, regulators, and other stakeholders who are requiring or encouraging increased transparency of clinical trial results.

Building on WHO’s 2005 call to register all interventional clinical trials and its establishment of the International Clinical Trial Registry Platform (ICTRP), this statement goes a step further to expand access to results, whether they are positive, negative, or incomplete. WHO called for reporting of results for all studies both through publication in peer-reviewed, preferably open access, journals and by updating the results section of the primary clinical trial registry within specific timelines.

Recent evaluation has shown that while progress has been made in increasing the registration of clinical trials, the results of many trials are still not widely available. WHO’s statement draws particular attention to the need to report negative and inconclusive trial results, which continue to lag significantly behind positive trial results in terms of reporting and publication. In addition, the WHO statement underscores the importance of reporting older, previously unpublished clinical trial results.

PATH shares WHO’s view that increased reporting of trial results will foster more informed regulatory and public health decision-making, expand access to information among clinical trial patients and the scientific community, and improve resource allocation for both developing and financing health interventions.

PATH’s portfolio of innovative health solutions—including drugs, vaccines, and medical devices—relies on the openness and accessibility of clinical trial results to partners and communities around the world. As we work together to tackle the most challenging health problems, all communities, including those where the disease burden is highest, should have access to clinical trial results. PATH applauds the public- and private-sector research leaders paving the way to make clinical trial results publicly available and recognizes the positive impact this has on bringing health within reach for everyone.