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[india-drug] WHO launches plan to register all clinical trials


  • From: "Malhotra Samir" <samirmalhotra345@yahoo.com>
  • Date: Fri, 26 May 2006 21:08:36 -0700 (PDT)

Heres an interesting bit of information:

WHO LAUNCHES PLAN TO REGISTER ALL CLINICAL TRIALS

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.


Dr Samir Malhotra, MD (Physician), DM (Clinical Pharmacology)
Fellow, American College of Clinical Pharmacology (F.C.P.)
Assistant Professor, Pharmacology
Postgraduate Institute of Medical Education and Research [PGIMER]
Chandigarh City, India