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Clinical Trials

Learn About Clinical Research

Why participate in a clinical trial? Finding new and improved medicines is possible only through the help of people like you. Every clinical trial participant provides valuable information that might help improve medical research and knowledge.

People take part in clinical trials for many reasons, including the chance to:

Help in the development of a medicine that may benefit people in the future
Receive study-related monitoring for their health
Help find new cures and treatments for the future

Learn more about what to expect in clinical trials on the Lilly TrialGuide website here.

Diversity in Clinical Trials

Responses to medicines can vary depending on a number of factors, including someone’s genetic background, ethnicity, gender and lifestyle. This is why it’s critical for Lilly to have diverse representation in clinical trials – to gain the insights necessary to make medicines that will be the most effective for all people who use them.

Unfortunately, some populations have been historically underrepresented in clinical trials. As a result, important information about how medicines work in these diverse populations is not always available. In response, Lilly is creating a clinical trial diversity strategy to better understand patient access to clinical trials and to help reduce the barriers to enrollment of racially and ethnically diverse populations in U.S. clinical trials. The ultimate goal of improving representation of diverse populations in clinical trials is to improve health equity for all patients.

Clinical Trials Transparency

Lilly has a history of commitment to transparency for our clinical studies. In 2004, Lilly became the first company to voluntarily disclose the initiation of our clinical studies and post study results in a publicly available registry. Since the start of 2014, Lilly has enhanced our transparency initiatives in alignment with the  PhRMA/EFPIA Principles for Responsible Clinical Trial Data Sharing . Lilly recognizes that responsible sharing of clinical study data has the ability to enhance public health while safeguarding the privacy of patients, respecting the integrity of national regulatory systems and maintaining incentives for investments in biomedical research.

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 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 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 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 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 favorable or unfavorable 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.

Independent Clinical Research

In addition to sponsoring its own clinical research and research collaborations, Lilly has programs for considering external requests for Lilly provision of study drug and/or financial support for independent clinical research that is initiated, designed and sponsored by external researchers.

Lilly considers such requests for support of independent clinical research projects based on scientific merit and strategic fit with Lilly’s areas of research interest. These reviews are carried out by global committees composed of Lilly medical and scientific staff members from relevant therapeutic areas.

Health care and research professionals may submit a concept online.

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Lilly Trial Experience

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