FDAnews Drug Daily Bulletin


May 24, 2006

The World Health Organization (WHO) has launched an effort with the lofty goal of registering every clinical trial -- including preliminary studies -- that tests treatments on patients or healthy volunteers globally.

As part of its International Clinical Trials Registry Platform, which aims to set standards for the way in which information on clinical studies is made available to the public, the WHO is also recommending that 20 key details be disclosed at the time studies are begun. Specifics on just what those details would be were not made public.

The platform is a program designed to establish the norms and standards upon which international trial registration can take place ethically and scientifically, according to the WHO. The main components of the platform are:Norms and standards on which trials to register, what information needs to be registered, who is responsible for registration; A "register network" of primary and associate registers that meet WHO-specified criteria for quality and acceptability; A coordinated process for detecting and resolving duplicate registrations and the assignment of a Universal Trial Reference Number to each unique trial worldwide; and A one-stop search portal for searching registers worldwide.

Registry administrators can sign up to receive policy updates from WHO at http://www.who.int/ictrp/register_contact_form/en/index.html (http://www.who.int/ictrp/register_contact_form/en/index.html). (http://www.fdanews.com/did/5_101/)