Clinical trials

Clinical trial registration

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Lilly currently registers all Lilly-sponsored interventional clinical trials on clinicaltrials.gov and, in many cases, on other online registries. 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

Clinical studies of Lilly products may also be sponsored and reported by parties other than Lilly in other clinical trial registries.

Lilly currently registers all Lilly-sponsored interventional clinical trials on clinicaltrials.gov and, in many cases, on other online registries. 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

Clinical studies of Lilly products may also be sponsored and reported by parties other than Lilly in other clinical trial registries.

Clinical trial results

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Lilly posts results of all registered Lilly-sponsored clinical trials.

Since September 27, 2007, results of Lilly clinical trials have been presented on clinicaltrials.gov for compounds that are approved for use in humans. Since January 2019, results of all Lilly-registered clinical trials are provided on clinicaltrials.gov either 30 days after the approval of the medicine (Phase 1) or within one year after a trial has completed (Phases 2-4).

For medicines approved and trials completed prior to December 8, 2007, Phases 2-4 clinical trial results are presented in a Clinical Study Report (CSR) Synopsis format on this website's CSR Synopsis page.

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

Lilly posts results of all registered Lilly-sponsored clinical trials.

Since September 27, 2007, results of Lilly clinical trials have been presented on clinicaltrials.gov for compounds that are approved for use in humans. Since January 2019, results of all Lilly-registered clinical trials are provided on clinicaltrials.gov either 30 days after the approval of the medicine (Phase 1) or within one year after a trial has completed (Phases 2-4).

For medicines approved and trials completed prior to December 8, 2007, Phases 2-4 clinical trial results are presented in a Clinical Study Report (CSR) Synopsis format on this website's CSR Synopsis page.

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

Observational studies registration and results

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Lilly posts information on observational (or 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 the following:

Lilly posts information on observational (or 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 the following:

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 utilising 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 Lilly’s clinical study report synopses site.
• 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^®).

Clinical study data-sharing

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• 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.

Lilly makes patient-level data available from Lilly-sponsored studies on marketed drugs for approved uses following acceptance for publication. Lilly provides this access through the Vivli Center for Global Clinical Research Data website. Qualified researchers can submit research proposals and request anonymised data to test new hypotheses. Lilly’s data-sharing policies are provided on Vivli’s Members page.

For further information on the process for requesting data from Lilly studies, see the step-by-step process here.

Sharing results with patients

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

Lilly creates summaries of Phase 2 and 3 clinical trial results written in patient-friendly language using simple, everyday terms. These lay summaries are available to the study investigators to provide to study participants.

Publication policy

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Initially, observational studies that were started on or after September 1, 2007 are located at clinicaltrials.gov or Lilly’s clinical study report synopses site.

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®).

Since 2003, Lilly’s public policy on disclosure of clinical trial data has guided us to disclose publicly all medical research results that are significant to patients, health care providers or payers – whether favourable or unfavourable to a Lilly product – in an accurate, objective and balanced manner for customers to make more informed decisions about Lilly products.

As part of the Principles for Responsible Clinical Trial Data Sharing, Lilly reaffirms our commitment to consider for publication all company-sponsored clinical trials in the scientific literature, regardless of whether the results of the sponsors’ clinical trials are positive or negative. At a minimum, results should be submitted for publication in a peer-reviewed journal for all Phase 3 clinical trials (by 18 months after last patient visit) and for any clinical trial results of significant medical importance. This commitment also pertains to investigational medicines whose development programs have been discontinued.