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A clinical trial is a research study where volunteers agree to participate in a project to test an investigational medication
The trial is designed to discover whether this investigational medication works and if it is safe. It’s only through clinical trials and the help of volunteers like you that important questions about investigational medication can be answered.
What are clinical trials for?
Clinical trials test potential investigational medication to see:
- If the investigational medication works
- If there are safety concerns
- What the side effects are
*Please note that there is no guarantee that the investigational medication will be approved by the FDA and that the safety/efficacy profile has not yet been established in clinical trials
Are clinical trials safe?
Strict rules about how to run a clinical trial were put in place to protect the safety, well-being, rights and privacy of trial volunteers.
How are clinical trials set up?
Every clinical trial has a plan, also known as a protocol. The plan outlines the details of the trial, including which people may enroll, how long the trial will take, and how the results will be measured. Before the trial can start, an Independent review board (IRB) and the local government’s health authorities must approve this plan.
Keep in mind, clinical trials will only take place if:
- There is a scientific and medical reason for the trial
- There might be potential benefits and possible risks for the trial volunteer
The 4 phases of clinical research
Before a medication can be tested in a clinical trial, it must first be tested in animals to confirm that it is safe for testing in people. Testing investigational medication usually goes through the following 4 phases.
Phase I
Basic safety
These trials test an investigational medication to see if it is safe. In this phase, a small number of people, who may be healthy, are given the investigational medication. When the safety profile of the investigational medication has been established, the investigational medication can move to Phase II
Phase II
Does the investigational medication work?
These trials test an investigational medication on a larger group of people (usually a few hundred) with a specific disease for a longer time. This is done to see if or how the medication works, while also collecting further safety information. This is also known as the investigational medication's efficacy.
Phase III
Testing in a larger group
These trials test investigational medication in even larger groups of people (typically several hundred) with a specific disease. This phase compares the investigational medication to the usual medication used for the disease, or to a placebo (dummy medication that doesn’t have active ingredients).
Often a "double-blinded" method is used for clinical
trials. Double-blinded means that neither the participant nor the
doctor will know which medication or placebo the volunteer
receives.
Phase IV
Post-approval testing
In these trials, the medication tested has already been approved for use. Phase IV trials include the largest group of participants (usually several hundred to thousands of volunteers). Phase IV trials are sometimes called Post Marketing Surveillance Trials.
Want to know more?
Find out more about what it may be like to participate in a clinical trial.
What it may be to participate in a clinical trial
What is a clinical trial?
It’s important to attend every clinical visit so the trial team can better understand the results and ensure the safety of patients.
What is a clinical trial?
You and your trial team will be monitored closely and your team will be available for questions and support.
What is a clinical trial?
You can participate in a clinical trial if you meet the required criteria to join in.
What is a clinical trial?
Clinical trials are one of the most important steps to finding investigational medication.
Questions or concerns
Do you have any question about what it’s like being a clinical volunteer? Have a look at our answers to frequently asked questions.