Eli Lilly and Co. began to make good on its promise to make available summary clinical trials data on its medications by posting a large amount of data on its own Web site,<www.lillytrials.com>. Included in the data treasure trove are summaries of 37 clinical trials involving psychiatric medications, 32 of which have already been published or presented at major scientific meetings.
In a conference call with press December 8, the company said the postings were only the first of many.
“The Lilly registry will be the most comprehensive effort to date, by either a public or private entity, to publicly disclose clinical trial information,” said Alan Brier, M.D., Lilly's chief medical officer and a professor of psychiatry at the Indiana University School of Medicine.“ We believe the Lilly registry will become a tremendous resource for physicians and health care providers seeking important information about clinical research involving Lilly medicines.”
Brier noted that the site, at the time of its debut, contained about half of the data the company has committed to making public. Other data sets are complete but pending publication and will be disclosed shortly, while some are still being compiled and summarized. Brier said the site should be“ fully populated” by July.
The Web site is divided into four sections: completed trial results, a registry of ongoing trials to which new trials will be added when they begin enrolling patients, a list of trials now enrolling patients, and an education section that includes a glossary of terms. As of December 15, the site had seven clinical trials of duloxetine (Cymbalta), five of fluoxetine (Prozac), 13 trials involving atomoxetine (Strattera), one trial of the olanzapine/fluoxetine combination (Symbyax), and 11 trials involving olanzapine (Zyprexa) with patients who had either schizophrenia or bipolar disorder.
Of those 37 trials, only five appear to have not been previously published or presented at a scientific meeting: one on duloxetine, three on atomoxetine, and one on olanzapine. Each of the postings is substantial, including detailed descriptions of the trial objectives, design, outcome variables, evaluation methods, and results, presented as summary data in numerous tables.
To date, Lilly's effort is the most extensive of any of the major drug companies. GlaxoSmithKline launched its trials register Web site last summer after an out-of-court settlement with New York State Attorney General Elliot Spitzer. However, as of December 15, trials for only two drugs were posted on the site, neither of which is a CNS medication.
The Lilly Clinical Trials Register is posted online at<www.lillytrials.com>. GlaxoSmithKline's register is at<http://ctr.gsk.co.uk/welcome.asp>. The National Library of Medicine's Clinical Trials Register is posted at<www.clinicaltrials.gov>.▪
