Frequently asked
questions

Clinical trials are scientific studies where researchers investigate a drug’s or device’s impact on a disease or a person’s overall health. Clinical trials are governed by a number of rules and guidelines, which help to ensure the rights, safety, and well-being of trial participants. Clinical trials are an irreplaceable step in the process to develop new medicines and devices. Learn more about clinical trials.

Your well-being and safety rate above anything else while taking part in a Novo Nordisk trial. Clinical trials are strictly regulated by numerous requirements and laws in order to ensure your safety, rights, and confidentiality.

Clinical trials sponsored by Novo Nordisk will always be conducted according to all applicable laws and guidelines and only take place after approval is granted by the national regulatory authorities and institutional review boards.

Clinical trials will only be conducted if:

• They can be scientifically and medically justified.
• Potential benefits might outweigh potential risks.

During a trial, all adverse events, or side effects, are closely monitored and action is taken when necessary. Novo Nordisk also creates safety committees for all clinical research activities, which immediately take action on any safety aspect of research, if needed.

Clinical trials sponsored by Novo Nordisk will always be conducted according to the Declaration of Helsinki, an international agreement for ethical standards for medical research.

More specific information can be found in the agreement to take part. 

There are several benefits to taking part in clinical trials. You may:

• Get valuable information about managing your disease

• Get close medical monitoring during your participation

•  Get expert medical care at health care facilities in relation to your participation

• Possibly help others by contributing to medical research

There are many different reasons to volunteer for a clinical trial. Some people want to receive the latest investigational treatments, while others find satisfaction in knowing that they’re contributing to medical advancements. Volunteering is a personal decision, see our participant experience page for more information. To hear stories from past volunteers, visit our participant experience page.

Dependent on local regulations, participants of Novo Nordisk clinical trials might be compensated during participation for reasonable traveling expenses and loss of income

More than 25,000 people participate in a Novo Nordisk clinical trial each year. These trials are conducted at more than 5,000 trial sites, in 50 countries around the world. Novo Nordisk will usually have more than 100 active clinical trials at any given time. 

Yes. Protecting your privacy is very important. Novo Nordisk will always protect the use of personal data with the appropriate security measures and in compliance with all applicable local privacy legislation. More specific information can also be found in the trials agreement to take part or consent. 

While more specific information can be found in each individual trial specific agreement to take part or consent, involvement in a study will normally include:

• Taking the study medicine as prescribed by your study doctor
• Attending regular doctor visits for study-related health checks (known as study visits)
• Consistent contact with the study nurse or doctor throughout the study (by phone or in person)
• Keeping record of any changes to your medication and well-being in your study diary between study visits

In order to participate, you will go through a screening process where the doctor will determine if you are eligible. The investigator of the trial, or lead doctor/scientist, ensures that people who want to volunteer are able to participate based on the detailed information in the clinical trial plan, also known as the protocol. They will review the volunteer’s full medical history, perform a detailed medical examination, obtain a signed agreement to take part or consent form, and more.

You can enroll in any clinical trial at any time without a referral from your doctor.

You will always be given verbal and written information about the trial you’re participating in before you decide to take part. The trial doctor works with you to make sure you understand the details of the trial. This process is known as agreement to take part.

Please note that you cannot participate in a trial until you sign an agreement to take part form, which is a document stating that you understand all aspects of the trial and freely volunteer to take part.

The length of trials vary from weeks to years, and each trial is different. As a part of an agreement to take part or consent process, you will be informed upfront how long a specific trial is scheduled to last.

Yes. You may drop out of a trial at any time, for any reason and without your current or future medical care being affected.

Just like with any medication, there are sometimes side effects. Throughout the trial, doctors and nurses will closely monitor your health, and will make adjustments if needed.

Some trials may include a placebo. The placebo will look like the medicine being tested, but does not have any active ingredients. Though you may receive a placebo, keep in mind that placebos are a really important part of the clinical trials process, and are necessary to test the benefits of a treatment.

Yes. You are welcome to see your primary doctor at any time during your trial.

It is important that you commit to participating in the full study and attend your regular visits from start to finish so that the research team can follow your progress. Attending every visit helps the team better understand the study results, and you might also benefit from the clinic visits.

Even if you or your study doctor makes the decision for you to stop taking the study medicine ahead of schedule, it is still important to attend all visits, even if you are off treatment, until the end of the study.