At Novo Nordisk, we are committed to discovering, developing and delivering innovative medicines and delivery systems to address the unmet medical needs of people living with serious chronic diseases.

To achieve this, we conduct rigorous clinical studies to assess the safety and efficacy of investigational treatments, generating critical data to secure regulatory approvals and reimbursement, which enable the broadest patient and most sustainable access to new therapies.​ These studies are not possible without the commitment of patients who participate in them. 

We recognize and value this important contribution. We also understand that delays between clinical trial completion, regulatory approval, and reimbursement can impact timely access for patients who have participated in our clinical trials, who may benefit from post-trial access to the investigational treatment. 

Post-trial access refers to the provision of an investigational treatment following the completion of a clinical trial until the treatment becomes commercially available.

In accordance with our commitment to the highest ethical standards, including the Declaration of Helsinki¹ and the International Council for Harmonisation Good Clinical Practice², Novo Nordisk will consider the provision of post-trial access for each of our clinical trials.
 

Novo Nordisk will evaluate if post-trial access will be provided in advance of any clinical trial using a fair and consistent approach and based upon ethical principles.

The provision of post-trial access will be addressed in the trial protocol and as part of the informed consent process to provide full transparency to patients, investigators and ethics committees. If post-trial access is planned, individual patients must also meet specific criteria to be eligible, as described below.

Novo Nordisk will maintain ongoing review of post-trial access considerations, taking into account emerging data and other relevant factors. Any modifications to the initial protocol and informed consent will be communicated to clinical trial participants, investigators, and ethics committees.

Post-trial access will always be provided in accordance with all applicable laws and regulations.  

Post-trial access is not guaranteed and can cease at any time where medically, ethically or legally appropriate at the discretion of Novo Nordisk.​

Novo Nordisk may change our position on post-trial access at any time.
 

If Novo Nordisk decides to provide post-trial access to an investigational treatment, individual patient eligibility will be assessed by the following minimum criteria:

• Completed participation in a clinical trial in which the investigational product was administered.
• The patient’s treating physician and/or trial investigator has determined that post-trial access is the best medical option for the patient, based on their benefit/risk assessment for the individual patient and what is known about the investigational product at the time of the decision.
• Meets all other medical criteria required for post-trial access, as established by Novo Nordisk.
• Specifically consents to being treated with the investigational treatment post-clinical trial completion.