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 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.
27,000 participants took part in randomised phase 1-4 trials sponsored by Novo Nordisk in 2017. We conduct all trials 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 trials follow a protocol approved by national health authorities and ethics committees. Global standards are not compromised no matter where in the world or by whom the trials are conducted.
Our research activities only take place in countries where the environment, infrastructure, medical standards, Independent Ethics Committees (IEC) or Institutional Review Boards (IRB) are all adequate and regulated. 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.
Clinical trial protocols and outcomes (irrespective of the results), must always be made publicly available, following the international reporting standard Equator (ie CONSORT). 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.
All Novo Nordisk clinical trials are performed in accordance with the Declaration of Helsinki and the ICH GCP guidelines, in addition to a number of other international guidelines such as the Belmont report, Code of Federal Regulation (US), the CIOMS and the EU Clinical Trials Directive, the Nuremberg Code and UNESCO’s Universal Declaration on Bioethics and Human Rights. These are integrated into our global Standard Operating Procedures, ensuring we are in compliance with these guidelines when sponsoring or supporting clinical trials.
We also comply with national regulations in the countries where trials are performed. We have the same ethical standards globally and will only conduct clinical trials in countries where these standards are met. Our position further elaborates on our approach to clinical trials.
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, and reports to the Chief Medical Officer.
Our global management systems ensure respect for the dignity and rights of all clinical trial participants. These systems are continuously evaluated and updated to reflect changing ethical standards and emerging risks.
We track our performance on ethics and human rights in clinical trials. Our initiatives within the focus areas are overall on track and we are making continuous improvements:
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, 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.
1. Compassionate use’ is a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies and who cannot enter clinical trials (Source: EMEA).