14 APRIL 2015 ' GENEVA - WHO issued a public statement calling for the disclosure of results from clinical trials for medical products, whatever theresult. The move aims to ensure that decisions related to the safety andefficacy of vaccines, drugs and medical devices for use by populations aresupported by the best available evidence.

"Our intention is to promote the sharing of scientific knowledge in order to advance public health," said DrMarie-Paule Kieny, WHO Assistant Director-General for Health Systems andInnovation. "It underpins the principal goal of medical research: to serve thebetterment of humanity."

"Failure to publicly disclose trial results engenders misinformation, leading to skewed priorities for both R&Dand public health interventions," said Dr Kieny. "It creates indirect costs forpublic and private entities, including patients themselves, who pay forsuboptimal or harmful treatments."

Unreportedtrials lead to misinformation

For example, in a study that analysed reporting from large clinical trials (more than 500 participants) registered onClinicalTrials.gov and completed by 2009, 23% had no results reported. Theseunreported trials included nearly 300 000 participants. Among clinical trialsof vaccines against 5 diseases registered in a variety of databases between2006-2012, only 29% had been published in a peer-reviewed journal by the WHOrecommended deadline of 24 months following study completion.

"We need the collaboration of all these actors to enforce transparency in their jurisdictions in order toincrease the benefits and decrease the risks for patients, clinical trialvolunteers 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 animportant bearing on scientific research today. WHO also reaffirms the need forall clinical trials to be registered on a WHO primary clinical trial registryso that they can be accessible through the International Clinical TrialsRegistry platform. This will ensure transparency as to which clinical trialshave occurred, and allow verification of compliance with public disclosurerequirements.

The recent WHO move expands on a 2005 call for all clinical trials to be registered, and the subsequent establishmentof the International Clinical Trials Registry Platform. This registry platformregularly imports trial records from ClinicalTrials.gov, ISRCTN registry, EUClinical Trials Register, Australia New Zealand Clinical Trial Registry, PanAfrican Clinical Trial Registry and Clinical Trial Registries from China,India, Brazil, Republic of Korea, Cuba, Germany, Iran, Japan, Sri Lanka, TheNetherlands and Thailand.

For more information pleasecontact:

Tarik Jasarevic
Communications Officer
Mobile: +41 79 367 62 14
E-mail: jasarevict@who.int

Daniela Bagozzi
Senior Information Management Officer
Mobile: +41 79 603 72 81
E-mail: bagozzid@who.int

Source: https://www.who.int/mediacentre/news/notes/2015/medical-research-transparency/en/