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Clinical trials

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Learn about clinical trials

A clinical trial is a research study that tests a medicine or therapy in people to help us understand how well it works and how safe it is.

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Clinical trials contribute to the advancement of medicine with the goal of making life better for
people. Looking for more details on what to expect from our clinical trials? Find more information here on what to expect.
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Find a clinical trial
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https://trials.lilly.com/en-US
Find a Clinical Trial
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Learn about

clinical research

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Clinical trial inclusivity

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Including diverse groups of people in any clinical trial is extremely important because people respond differently to medicines depending on their age, sex, race, ethnicity and many other factors. To make sure this trial diversity happens, we work with communities from the start to make our clinical trials as inclusive and accessible as possible for people around the world.

Learn about our commitment to diversity in clinical trials here.
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Clinical trial participants

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We can’t conduct trials without help from clinical trial participants. Every clinical trial participant provides valuable information to advance medical research and helps move medicines forward to reach countless people waiting for them.
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Expanded access

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For patients who are not eligible to participate in a clinical trial, expanded access may be a possibility.

Learn more about expanded access here.

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Watch this TIME 100 video
https://delivery-p137454-e1438138.adobeaemcloud.com/adobe/assets/urn:aaid:aem:810ab9c0-3e33-4fc3-a3e2-c67e46be9f0a/play?assetname=TIME_Eli_Lilly_LF_FINAL_SUBS.mp4

00:00-00:02
[Music playing]
[Sun rising over a river and fields]

00:03-00:10

[Music continues playing in the background while a fly fishing hook is tossed into the water. A white Lilly logo appears on the bottom right of the screen. Paul appears on the screen and is fly fishing in a wooded area in the background.]

Paul:
One of the good things about fly fishing is that it takes your mind off of the other things you worry about.

00:11-00:12

[Music continues playing in the background as the screen fades to Paul facing the water with his back to the screen. He has a small fishing net on his back.]

Paul:
That's where I find peace.

00:14-00:15

[Music continues playing in the background as the screen fades to Paul sitting in a home dining area. There is a mug on the table beside him. Paul's name, Paul R., Cancer Trial Patient, appears on the bottom left of the screen.]

Paul: I was diagnosed about 11 years ago with a very rare type...

00:16-00:18

[Music continues playing in the background as the screen fades to hands typing on a keyboard.]

Paul:
...of cancer that has no cure with four to five years...

00:19-00:24

[Music continues playing in the background as the screen fades up to Paul's torso and face.]

Paul:
...of life expectancy. My first round of treatments did not remove all of the cancer,...

00:25-00:34

[Music continues playing in the background as the screen fades to Paul sitting on a balcony working.]

Paul:
...so then I was introduced to clinical trials. I started these trials. In some ways, I was hoping for a cure.

00:35-00:49

[Music continues playing in the background as the screen fades to Paul sitting in a home dining area. There is a mug on the table beside him.]

Paul:
There's a time commitment. There's the uncertainty of what the future's gonna be, but there's also the hope that it'll work and the many moments that it brings you to be with loved ones and do the things you love to do in the future.

00:50-00:53

[Music continues playing in the background as the screen fades to Paul sitting in a chair in an office or living room area. Then the screen fades to a pen writing in a notebook.]

Paul:
The positives have far outweighed all of the downsides...

00:54-00:58

[Music continues playing in the background as the screen fades to a close-up of Paul sitting.]

Paul:
...for me in that I've been on the front edge of medicine.

00:59-01:05

[Music continues playing in the background as the screen fades to a boy walking outside holding a fishing pole and tackle box.]

Paul:
My grandchildren are really a high priority. One of my dreams was, and my hopes was that I would live long enough...

01:06-01:15

[Music continues playing in the background as the screen fades to a close-up of Paul sitting.]

Paul:
...for them to remember me. So I was willing to take some risk. And of course, they're 11 years old now, so it's been, it's been a good journey.

01:16-01:20

[Music continues playing in the background as the screen fades to Paul walking out a door holding two glasses and a woman sitting on a patio and looking at the backyard.]

Paul:
I've been in remission for close to five years now,...

01:21-01:25

[Music continues playing in the background as the screen fades to Paul handing one of the glasses to the woman and then sitting down next to her and rubbing her back.]

Paul:
...and it's just been a really blessing in my life.

01:26-01:28

[Music continues playing in the background as the screen fades to an aerial view of a city.]

01:29-01:31

[Music continues playing in the background as the screen fades to Allison and her husband walking down a sidewalk holding hands.]

Allison: I love traveling the world. I love being with my family.

01:32-01:35
[Music continues playing in the background as the screen fades to Allison pushing two boys on swings at a playground.]

Allison:
We have a couple of nephews and a niece too, and it's amazing to be able to show them...

01:36-01:41

[Music continues playing in the background as the screen fades to Allison sitting in a home setting. Her name, Allison K., Cancer Trial Participant, appears on the bottom left of the screen.]

Allison:
...and it's amazing to be able to show them that Auntie Alli can beat the odds.

01:42-01:54

[Music continues playing in the background as the screen fades to a woman in a medical bed with a close-up of an IV drip. The screen then fades back to Allison sitting in a home setting.]

Allison:
I was diagnosed when I was 31 years old with cancer. I did a harsh regimen of chemotherapy, and I was starting to question the quality of life versus how much time I had left.

01:55-02:02

[Music continues playing in the background as the screen fades to a person entering feet first in to an MRI machine and then to a person lying on a bed and entering a CT/PET machine.]

Allison:
With any clinical trial, you're taking a leap of faith because you don't really know...

02:03-02:05

[Music continues playing in the background as the screen fades to a close-up of Allison sitting.]

Allison:
...how this medicine is gonna react.

02:06-0:208

[Music continues playing in the background as the screen fades to a hand with an IV lying in a medical bed.]

Allison:
The anxiety of the unknown...

02:09-02:20

[Music continues playing in the background as the screen fades to Allison sitting in a home setting.]

Allison:
...and not having a purpose was probably one of the hardest things that I faced in this whole journey. But after my first scan, my tumors were shrinking, so I knew that medicine was working...

02:21-02:27

[Music continues playing in the background as the screen fades to Allison and her husband sitting on a sofa looking at photos in a photo album.]

Allison:
...to have a new purpose, to promote clinical trials,...

02:28-02:33

[Music continues playing in the background as the screen fades back to Allison sitting in a home setting.]

Allison:
...to show others that you can overcome odds that are given to you.

02:34

[Music continues playing in the background as the screen fades to Allison and her husband dancing at their wedding.]

02:35-02:42

[Music continues playing in the background as the screen fades back to Allison and her husband sitting on a sofa looking at photos in a photo album.]

Allison:
Remember how many times we practiced this? It was definitely my mission to make it to the wedding.

02:43-02:46

[Music continues playing in the background as the screen fades to a photo of Allison and her husband on their wedding day and then back to Allison and her husband smiling looking at the photo.]

Allison:
It was the best day of my life. We had so much to celebrate.

02:47-02:52

[Music continues playing in the background as the screen fades back to Allison sitting in a home setting and Alison is smiling.]

Allison:
We had each other, we had overcoming cancer, so it was a great day.

02:53-02:55

[Music continues playing in the background as the screen fades back to a photo of Allison and her husband embracing, looking at each other in a field on their wedding day.}

02:56-03:05

[Music continues playing in the background as the screen fades to a sun rising over a lake.]

Bill:
It's Saturday in Northwest Ontario. This is a beautiful site. I like to go fishing and getting off of the grid. You turn 'em upside down like this,...

03:06-03:11

[Music continues playing in the background as the screen fades to Bill sitting in a boat and releasing a fish that he caught.]

Bill:
...and they don't flop around on you. I have some history of Alzheimer's in my family.

03:12-03:15

[Music continues playing in the background as the screen fades to Bill sitting in a chair or barstool at a kitchen island. His name, Bill S., Alzheimer's Trial Participant, appears on the bottom left of the screen.]

Bill:
I thought if there was a way to cut this off or halt it, I though I should do that.

03:16-03:20

[Music continues playing in the background as the screen fades to a medical professional and patient meeting. A stethoscope is on the table.]

Bill: So I researched the study and volunteered.

03:21-03:22

[Music continues playing in the background as the screen fades to Bill sitting in a chair or barstool at a kitchen island.]

Bill:
I was in it for seven years.

03:24-03:26

[Music continues playing in the background as the screen fades to an IV drip.]

Bill:
It entailed getting a monthly infusion,...

03:27-03:31

[Music continues playing in the background as the screen fades to a car driving on a country road as the sun rises.]

Bill:
...so it was a commitment of time and mileage.

03:32-03:35

[Music continues playing in the background as the screen fades to another view of multiple cars driving on a road as the sun rises. The screen fades back to Bill sitting near a kitchen island.]

Bill:
Well over 8,000 miles driven. My wife would go with me,...

03:36-03:38

[Music continues playing in the background as the screen fades to bacon frying in a pan and fades to a close-up of Bill cooking the bacon.]

03:39-03:41

[Music continues playing in the background as the screen fades to Bill's wife, who walks towards Bill and is carrying two mugs.]

Bill's wife:
Brought you some coffee.

Bill:
All righty.

03:42

[Music continues playing in the background as the screen fades back to Bill sitting in a chair or barstool at a kitchen island.]

Bill:
It just became part of our life.

03:43-03:44

[Music continues playing in the background as the screen fades to Bill and his wife sitting at a table with breakfast and toasting glasses.]

03:45-03:47

[Music continues playing in the background as the screen fades back to Bill sitting in a chair or barstool at a kitchen island.]

Bill:
The path to success on any of these drugs is long,...

03:48-03:58

[Music continues playing in the background as the screen fades to a person riding their bike on a rural two-lane road.]

Bill:
...and these pharmaceutical companies work hard for that. I think everybody wants to leave the world a little better place than when they found it,...

03:59-04:03

[Music continues playing in the background as the screen fades back to Bill sitting in a chair or barstool at a kitchen island.]

Bill:
...but only a few people have an opportunity to really impact the greater good of society.

04:04-04:17

[Music continues playing in the background as the screen fades to Paul carrying a fishing rod down a path in a wooded area. The screen then fades to a close-up of Bill sitting in a house.]

Paul:
At least two of the medicines I've been on are now first line defenses for the cancer that I'm on. Realizing that many other people now get the benefit from it has been a real gratifying experience.

04:18-04:26

[Music continues playing in the background as the screen fades to Allison and her husband walking down a sidewalk holding hands.]

Allison:
I hope that the scientists and researchers know that they are heroes...

04:27-04:31

[Music continues playing in the background as the screen fades to a close-up of Allison sitting.]

Allison:
...because they get to create these medicines that can change the world.

04:32-04:39

[A black background with "Eli Lilly and Company thanks all participants and volunteers of clinical studies. Without these heroes, scientific breakthroughs in medicine would not be possible." in white text appears on the screen.]

04:40-04:44

[The screen fades to a red background with a white Lilly logo, and the words "A medicine company" appear underneath the logo on the screen. Centered at the bottom of the screen in white text are the words, "PP-LU-US-1236 9/2024, ⓒLilly USA LLC, 2024. All rights reserved."]

04:45-04:47

[The screen fades to a black background, and a red box with the words "Red Border" appears in the box and "By TIME" appears underneath the box.]

04:48-04:49

[Lilly logo appears over a red background.]

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Thank you, clinical trial participants

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Clinical trial participants help pave the way for new, groundbreaking medical treatments. In collaboration with TIME, we're highlighting stories from three clinical trial participants who share their experiences. We're grateful to every participant—like Paul, Allison and Bill—who help us advance science.
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Clinical trials transparency

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We have a history of transparency when it comes to our clinical studies. In 2004, we became the first company to voluntarily disclose our clinical studies initiation and post-study results in a publicly available registry.

Since the start of 2014, we have enhanced our transparency initiatives to align with the PhRMA/EFPIA Principles for Responsible Clinical Trial Data Sharing. We recognize that sharing clinical study data can enhance public health. But responsibly sharing that data is necessary to safeguard the privacy of patients, respect the integrity of national regulatory systems, and maintain incentives for investments in biomedical research.
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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.

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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.

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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.

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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.

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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:

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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:

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®). As of 2024, Lilly registers and posts results from observational/non-interventional studies on the Head of Medicines Agency (HMA)-European Medicines Agency (EMA) Catalogue of Real-World Data (RWD) studies, the current European Union register.
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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.
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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 anonymized 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.
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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.
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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.
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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®).
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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.
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Independent clinical research

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In addition to sponsoring our own clinical research and research collaborations, we also have programs that allow us to support external requests. We can provide resources and/or financial support for independent clinical research that is initiated, designed and sponsored by external researchers.

We consider independent clinical research projects based on scientific merit and strategic fit with our 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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Submit a concept now
link
https://www.lillyinvestigatorresearch.com/
submit a concept now for resources and/or financial support for independent clinical research
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Find a clinical trial near you

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Find a trial
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https://trials.lilly.com/en-US
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