Eli Lilly and Company would disclose the results of all clinical trials for which Lilly is a sponsor via a publicly available registry, beginning in the fourth quarter of this year. Consistent with the company's policy of open disclosure, the registry will include results of all phase I through phase IV clinical trials of Lilly's marketed products conducted anywhere in the world. Additionally, the company will begin posting the initiation of all phase III and phase IV clinical trials via the registry, company informed in a release.
"Lilly understands that patients, customers, and critics are looking for transparent answers that provide value to the health care decision-making process," said Sidney Taurel, Lilly's chairman, president and chief executive officer. "Our announcement 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," he asserts.
For each clinical trial of its marketed products, the company will disclose publicly the results corresponding to the study's predefined primary and secondary outcome measures that are specified in the study protocol, as well as additional safety and efficacy results that impact patient care and the clinical use of Lilly products. Results that do not support the hypothesis being tested or that are contrary to the expected outcome will be disclosed. Additionally, Lilly will post a comprehensive description of the trial design and methodology for each study.
Additionally, the company will publicly report the initiation of all Phase III and Phase IV clinical trials, with an identifier assigned to each trial. When the trial is completed and the drug is commercially available, the results of the trial will be appended to its identifier, the release said.
For phase I, II and III studies, Lilly will disclose clinical trial results when a drug's indication is approved and it is commercially available. Phase III trial results for secondary indications of marketed drugs that fail to achieve approval will also be posted. For Phase IV studies, Lilly will disclose clinical trial results as soon as possible after the data analysis is completed but no later than one year after the trial's completion. For studies that are under review by a peer-reviewed journal that prohibits pre-publication disclosure of results, the results will be posted on the registry at the time of the publication.
In all cases, Lilly will disclose clinical trial results on a publicly available, on-line registry. Lilly also will seek to disclose results through a peer-reviewed medical journal, subject to the discretion of the journal editors. The company will commit to providing a reference in the clinical trial registry for study results that are disclosed in a peer-reviewed journal. In addition, Lilly's clinical trial results may be disclosed through presentations or abstract submissions at professional scientific meetings, the release added.
"Our support of a publicly available clinical trial registry is a natural extension of Lilly's commitment to disclose data from Lilly-sponsored clinical trial data," Dr. Alan Breier, vice president and chief medical officer at Eli Lilly and Company said adding, "A publicly available clinical trial registry, which provides results from all industry-sponsored clinical trials of marketed products, 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."
Implementation of these standards will begin with all clinical trials of marketed products that are completed after July 1, 2004. In addition, the registry will be populated retrospectively with results of core efficacy and safety registration trials of marketed compounds approved since July 1, 1994.