WHO Pushes for Prompt Reporting and Public Disclosure of Clinical Trial Data

April 17, 2015
Adeline Siew, PhD

Adeline Siew is editor for Pharmaceutical Technology Europe. She is also science editor for Pharmaceutical Technology.

WHO says that results from clinical trials should be reported within 12 months of completion of the study

 

The World Health Organization has released a statement calling for public disclosure of clinical trial results. It reaffirms the ethical imperative of clinical trial data reporting and defines timelines for publishing study results. 

In its statement, WHO says that results from clinical trials should be reported within 12 months of completion of the study. WHO is also calling for publication of results from previously unreported trials to be made publicly available, and reiterates that governments and organizations should implement measures to achieve this transparency in clinical trial data. WHO has outlined steps to improve linkages between clinical trial registry entries and their published results.

The latest version of the Declaration of Helsinki states that all human studies must be registered in a publicly accessible database before recruitment of the first subject begins. It also states that researchers are responsible for making study results available to the public, and this includes negative and inconclusive data.

WHO’s call for clinical data disclosure builds upon its 2005 statement that “the registration of all interventional trials is a scientific, ethical, and moral responsibility.”