Clinical Study Registration and Results

Registration

Eli Lilly and Company currently registers all Lilly-sponsored interventional clinical trials at a minimum on clinicaltrials.gov. Lilly-sponsored studies are registered as follows:

  • Phase 2, phase 3 and phase 4 clinical trials initiated on or after October 15, 2002
  • Phase 1 clinical trials in patients initiated on or after October 1, 2009
  • Phase 1 clinical trials in healthy subjects initiated on or after October 1, 2010.

Note that clinical studies on Lilly products may also be sponsored and reported by parties other than Lilly in other clinical trial registries.

Results

Eli Lilly and Company posts results of all registered Lilly-sponsored clinical trials.

For trials on compounds that are approved for use in humans, the results of registered trials are provided on clinicaltrials.gov either 30 days after the approval of the medicine or one year after the trial is completed, whichever is later. These results are for trials that have completed after September 27, 2007.

For trials completed prior to December 8, 2007, the results are presented in a Clinical Study Report (CSR) Synopsis format on our CSR Synopsis page.

Lilly will also provide results of the registered Lilly-sponsored clinical trials for compounds whose development has been terminated on or after October 1, 2009.

Observational Studies

Lilly posts information on observational / non-interventional Lilly-sponsored studies that started on or after September 1, 2007.

The studies posted are those where a Lilly marketed product is evaluated in comparison to alternative treatment(s) or control group(s), using pre-defined hypotheses/endpoints. These include:

Studies with primary patient-level data collection

  • Prospective effectiveness studies evaluating the extent to which treatment with a Lilly marketed product improves patient outcomes compared to the alternative treatments in actual clinical practice.
  • Prospective pharmacoepidemiologic studies, i.e. studies that are designed to assess the risk attributed to a drug exposure.

Studies utilizing secondary data sources or databases with safety as the primary endpoint.

  • Retrospective pharmacoepidemiologic studies, i.e. studies that are designed to assess the risk attributed to a drug exposure.

Lilly observational studies may be registered at the following locations. Initially, observational studies that were started on or after September 1, 2007 are located at clinicaltrials.gov or lillytrials.com.

Starting in 2014, Lilly started registering and posting results to observational / non-interventional studies on the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (ENCePP®).