Statement from PATH in support of WHO call for public disclosure of clinical trial results

April 14, 2015 by PATH

New guidelines part of a growing movement to increase transparency and availability of clinical trial results

Claire Hudson, PATH

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 In addition, the WHO statement underscores the importance of reporting older, previously unpublished clinical trial results.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.

Posted April 14, 2015.