LILLY ADOPTS WHO CLINICAL TRIAL REGISTRATION STANDARDS

Eli Lilly has formally adopted clinical trial registration standards proposed by the World Health Organization (WHO) -- a commitment that comes roughly one year after the company became the first major drugmaker to launch an online trial registry.

As part of its efforts to meet the WHO standards, Lilly will publicly disclose the following information when initiating a clinical trial: unique trial number, trial registration date, secondary identifiers, funding sources, primary and secondary sponsors, responsible contact person, research contact person, brief title, research ethics review, condition, key inclusion and exclusion criteria, study type, anticipated trial start date and recruitment status.

The information will be disclosed on Lilly's in-house trial registry -- www.lillytrials.com (http://www.lillytrials.com) -- and on the federal government's trial database at www.clinicaltrials.gov (http://www.clinicaltrials.gov), Lilly said. The company launched its registry last year in the face of increased pressure from lawmakers to publicly release the results of all clinical trials.

The WHO crafted its minimal data set standards in April as part of a broad effort to facilitate access to clinical trials and their results. The standards have been adopted by numerous medical and healthcare organizations, including the International Committee of Medical Journal Editors (ICMJE), which includes editors from the industry's most prominent journals, including the New England Journal of Medicine, the Journal of the American Medical Association, The Lancet and the Annals of Internal Medicine.

ICMJE criticized the drug industry earlier this year for failing to disclose important data sets when registering clinical trials at www.clinicaltrials.gov. The editors' complaint came in the wake of a NIH review that showed many entries in the federal database did not include meaningful information in some key data fields.