Clinical trials

Clinical trials are essential in the development of medicines. Without trials, the efficacy, safety and optimal use of medicines could not be documented.

Clinical trials and clinical research activities have a direct impact on a number of human rights. These include the right to free informed consent to medical and scientific experimentation, access to remedy, access to information, quality of life and the right to privacy.

At Novo Nordisk, we conduct all trials and clinical research activities in accordance with international ethical and human rights principles - which respect the rights, integrity and dignity of all participants - to ensure their safety and well-being. In trials requiring the participation of children, we protect and ensure the rights of children.

clinical trial mainpic

Contact person
Karin Kramer Nielsen
KKN@novonordisk.com

Assessing risks

Our position on clinical trials

Clinical trial ethic governance

Novo Nordisk has a governance structure in place which ensures that current and new regulations, directives and external guidelines are adhered to and that all clinical research activities are approved both by medically qualified staff and senior management. Our Chief Medical Officer is accountable for ensuring that Novo Nordisk respects the rights, integrity and dignity of people participating in clinical trials. The Chair of the Bioethics Council coordinates ethical standards, including respect for human rights.

 

More information about our bioethics governance


Performance

Reporting concerns

We ensure clinical trial participants can easily access information about their rights and the grievance process. In the case of any concerns or complaints, this is provided through the national health authorities and patient ombudsman or ethics committees.

We ensure that participants are compensated for any clinical research-related injury according to domestic law.


Stakeholder engagement

We have regular consultations with healthcare professionals on clinical research design and protocols. To ensure that the rights and well-being of trial participants are given priority, all investigators working on our clinical trials are trained in Good Clinical Practice. When necessary, we offer such training for doctors, nurses and pharmacists at clinical research sites.

 

Sharing value with key stakeholders

We are a member of several industry associations, including the European Pharmaceutical Industry Association (EFPIA), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA). Through these associations, we work with regulatory authorities to improve the requirements for clinical trials conduct, such as the revision of the Declaration of Helsinki. We also engage with patients regarding the design or protocol of a trial to improve our efforts to respect participants’ rights.


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