What to Expect

What happens before the trial?

Before participating in a study, participants are provided information about the study and are given the chance to ask questions. This process is called Informed Consent. The purpose of the informed consent process is to make sure participants are adequately informed of important details about the clinical study so they can make an informed choice about their participation. Informed consent begins before a research volunteer agrees to participate in a trial and continues throughout the study.

The Informed Consent document describes the study to research participants. It includes details about the study’s purpose, length, procedures, risks and benefits, and other information that all participants should know. Participants sign the document before they enter the study, but only after having read and discussed it with the research team and demonstrating an understanding of the information provided. In some cases, there will be multiple Informed Consent documents throughout the study as changes are made to the study protocol or new safety information becomes available. Signing the document(s) and providing consent is not a contract. Participants may withdraw from a study at any time, even if the study is not over.

What happens after my trial?

You join the community.

As a clinical study participant, you would belong to a large community of volunteers around the world. Together study participants help researchers answer important health questions and discover new medical treatments.

You can discuss continuing treatment.

After your participation has ended, you and your doctor should work together to determine the best next steps in your care. Sometimes studies are designed to provide access to the study medication for longer periods after the study is over. However, this is the exception, not the rule, so please discuss it with your study doctor.

The trial might move forward and might not.

What happens after the trial results are analyzed depends on the phase of the trial. After a Phase 1 or 2 trial the results will tell the researchers whether to move on to the next phase or to stop testing because the drug was unsafe or ineffective. When a Phase 3 trial is complete, the researchers examine the data and decide whether the results have medical importance.

The drug can become approved for use.

Once a new drug or treatment has been proven safe and effective during all three phases, it may become approved for use. To do so, researchers need to submit the research results to country-specific authorities (like the FDA in the US) in order to make the drug available for patients. But not all experimental drugs or treatments will be approved.

You can access results of the research.

Obtaining the results of your trial will depend upon both the company responsible for the research and the site where it was conducted. If you participate in a Lilly clinical trial, we are working on the best way to provide you results in a manner and timeframe that is meaningful and responsible. Please check back on our progress. You may also access trial results on www.clinicaltrials.gov. Bear in mind that trial results can take some time to be available. Though you may have completed your participation in a clinical trial, the same trial may still be ongoing for the other volunteers in that study. And while some trials are completed in a week, other trials take several years.

Step 1

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The last participant visit takes place

Step 2

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All data is 'locked', meaning no changes can be made

Step 3

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All collected data is reviewed and analyzed by statisticians

Step 4

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A clinical trial report is completed

Up to 12 Months

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