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.
Doctors (investigators) must obtain free informed consent from each participant and ensure their rights and well-being during and after the trial. Investigators and research teams must be offered fair reimbursement for their costs and labour. Trials must undergo independent scientific and ethical review and approval, and are subject to random audits by authorities during or after their execution.
For every clinical trial we sponsor, Novo Nordisk establishes safety committees that report any adverse events on a global level to health authorities, and who take appropriate action when required.
In addition, Bioethics
Expert Groups keep track of emerging issues, re-evaluate risks and
act upon any findings. Current topics under review include: global
adherence to ethical guidelines, focus on vulnerable populations in
informed consent (especially children), transparency in
investigator-sponsored studies, use of social media and collection
of clinical data in real world evidence studies.?
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
In 2017, we produced a paediatric patient information assent form. We ensure children participating in trials are able to express their own views freely in all matters affecting them. Their views are given due weight corresponding to their age and maturity, in accordance with the Convention on the Rights of the Child.?
We provide lay person
language informed consent forms to improve the readability of the
material. Tests showed that readers better understood the key
concepts and decisions when participating in clinical research, eg
voluntarism, randomisation and placebo control. We have also
improved the information regarding concerns or complaints for
participants. These revisions have been completed with the help of
health literacy experts and patient organisations.
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.
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.
We are a member of several industry associations and non-profit organisations, including the European Pharmaceutical Industry Association (EFPIA), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) and TransCelerate Biopharma Inc. 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.