Lilly to disclose clinical trial results
pharmafile | August 4, 2004 | News story | |Â Â Â
Lilly has responded to calls for greater disclosure of clinical trial results by pledging to publish more data through its dedicated online public registry, www.lillytrials.com.
The US company's announcement follows the controversy around GlaxoSmithKline's handling of data for its antidepressant Seroxat/Paxil- New York state attorney general Elliot Spitzer filed a lawsuit against the company earlier this year alleging a cover-up of negative data relating to the safety of the drug in children.
GSK has denied the accusations, and announced in June that data for Seroxat and all its other marketed drugs would be made openly available via the web.
Lilly has now made a similar pledge, promising to release information from phases I-III of a drug's development once it is approved, stressing that "results that do not support the hypothesis being tested or that are contrary to the expected outcome will be disclosed".
The company says the data disclosed will relate to the study's pre-defined primary and secondary outcome measures specified in the study protocol, as well as "additional safety and efficacy results that impact patient care and clinical use of Lilly products".
"Lilly understands that patients, customers, and critics are looking for transparent answers that provide value to the healthcare decision-making process," said Sidney Taurel, Lilly chairman, president and chief executive officer. "Our announcement today represents a comprehensive effort to publicly disclose Lilly's clinical trial information. These actions should prove to be invaluable for patients and the medical community as they seek to make informed decisions about Lilly medicines."
The company says phase III results for secondary indications of marketed drugs which are rejected by regulators will also be published, while phase IV post-marketing studies will be published as early as possible and no later than one year after the trial completion.
Medical journals which publish a large proportion of industry studies have their own peer-review and publication programme which prohibits earlier disclosure – in these instances, the data will be published online at the time of publication.
Dr Alan Breier, vice president and chief medical officer at Lilly said it also supported the idea of an industry-wide centralised clinical trial registry of marketed products.
"[This] could prove useful to both physicians and patients seeking information on a broad range of illnesses from serious and potentially life-threatening diseases to chronic and debilitating conditions including depression, osteoporosis and diabetes," he said.
Lilly will begin to make the data available in the fourth quarter of this year on www.lillytrials.com, and says it will continue to post news of new trials for serious and life-threatening diseases via the US government website www.clinicaltrials.gov.
The controversy around Seroxat/Paxil and SSRIs in Europe and the US could prove the decisive factor in the creation of a single industry database of clinical trials, which looks increasingly likely in the long-term.
In June, the American Medical Association (AMA) and the International Committee of Medical Journal Editors (ICMJE) both put forward proposals for such a system. US pharma company Merck has already declared its support for the AMA plan and GSK and now Lilly's announcement may see other companies follow suit.
