Clinical trials ethics

We conduct all trials and clinical research activities in accordance with international ethical and human rights principles. These principles 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.

Why conduct 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.

Man on bicycle

Christian Petersen has type 2 diabetes and lives in Denmark

Uncovering risks

Clinical trials follow a protocol approved by national health authorities and ethics committees. All ourclinical trial protocols and outcomes (irrespective of the results), are made publicly available, following the international reporting standard Equator (ie CONSORT).

Global standards for clinical trial activities are never compromised and 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.

For every clinical trial we sponsor, we establish 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. 

Our approach

Clinical trials ethics

Our position on clinical trials

All Novo Nordisk clinical trials and clinical research activities are governed by national laws and international conventions.

Although variations exist in local laws, cultures, customs and practices, Novo Nordisk’s position is founded on international common guidelines and regulations such as The Declaration of Helsinki, International Conference on Harmonisation Guideline for Good Clinical Practice, Good Pharmacoepidemiological Practice, the Nuremberg Code, United Nations (UN) Guiding Principles on Business and Human Rights, the Belmont report, UNESCO’s Universal Declaration on Bioethics and Human Rights.

These are integrated into our global Standard Operating Procedures, ensuring that all Novo Nordisk’s clinical research activities are in compliance with these guidelines.

 

Novo Nordisk will:

  • Ensure that the above standards are applied globally for the safety, rights, integrity, confidentiality and well-being of participants in Novo Nordisk sponsored clinical research, and that these always prevail over interests of science, society and commerce.
  • Ensure that the above standards are applied globally for the safety, rights, integrity, confidentiality and well-being of participants in Novo Nordisk sponsored clinical research, and that these always prevail over interests of science, society and commerce.
  • Ensure that each clinical research activity has a clear and detailed protocol based on sound medical and scientific methodology and ethical considerations outlined in these principles. Prior to study start clinical research protocols must always be approved by Independent Ethics Committees (IEC) or Institutional Review Boards (IRB) or other appropriate bodies as required locally. Approval by regulatory authorities is also required as applicable by local law.
  • Ensure that trial information for all Novo Nordisk sponsored clinical research is registered in publicly accessible databases according to current requirements.
  • Ensure that signed informed consent is obtained for all participants in Novo Nordisk sponsored clinical research, before any clinical activity is initiated. This consent should be based on appropriately provided information. Dissent must always be respected.
  • Ensure that special consideration is given to vulnerable patient populations (including but not limited to children and elderly). If clinical research involves minors, processes for seeking informed consent from the minor and/or the minor’s legally authorised representative must take place in accordance with local regulations.
  • Ensure that placebo-controlled clinical trials are only conducted when scientifically and ethically justified, and that participants are informed about potential implications of the placebo treatment.
  • Ensure that reimbursement of expenses and compensation to clinical trial participants is described in the informed consent and approved by the local IRB/IEC and/or Health Authorities according to laws and regulations. This should not unduly incentivise a subject to participate or continue participation in a clinical research activity.
  • Ensure that compensation to investigators, study staff and institution’s undertaking clinical research activities, follows fair market value and approval by the local institution, IRB/EC and/or Health Authorities according to applicable laws and regulations. Novo Nordisk will disclose these compensations as required by laws and regulations.
  • Ensure that clinical research is performed with the same ethical standards globally.
  • Novo Nordisk employees should avoid participation in Novo Nordisk clinical trials and non-interventional studies as trial/study subjects.
  • Ensure appropriate qualifications of Novo Nordisk and clinical research staff by documented education, training, and experience.
  • Ensure that clinical research activities only take place in countries with an adequate regulatory environment, infrastructure, medical standards and IEC/IRB. Novo Nordisk will only conduct clinical research with investigational medicinal products and/or investigational devices in countries where Novo Nordisk intends to market these.
  • Ensure that any investigational medicinal product used in Novo Nordisk sponsored clinical research is manufactured according to current Good Manufacturing Practise (GMP) requirements.
  • Ensure that participants in Novo Nordisk sponsored clinical research can withdraw consent to participate at any time without justification.
  • Ensure that Novo Nordisk honours the privacy of clinical research participants by safeguarding personal data with appropriate security measures. Novo Nordisk will only process personal data for legitimate purposes in accordance with applicable law.
  • Ensure that relevant safety information is continuously assessed during Novo Nordisk sponsored clinical research activities and appropriate actions are taken if the risk outweighs the potential benefits. Novo Nordisk also provides safety information to Health Authorities on an ongoing basis as required by regulations.
  • Ensure indemnification of clinical research participants in accordance with applicable laws and regulations.
  • Ensure that post-trial provisions of study medication are described in the protocol and informed consent.
  • Novo Nordisk may upon request make a medicine available which has not been authorised for the condition on a named patient basis, when this is expected to help the patient with a life-threatening, long-lasting or seriously disabling illness that cannot be treated satisfactorily with authorised medicines, or a patient who has a disease for which no medicine has yet been authorised.
  • Ensure accurate and timely generation, verification, handling, interpretation, and reporting of all data and results from Novo Nordisk sponsored clinical research activities according to global and local requirements.
  • Ensure documents and data from Novo Nordisk sponsored clinical research activities are stored in accordance with applicable laws and regulations.
  • Ensure results from Novo Nordisk sponsored clinical research activities are disclosed publicly in accordance with current requirements. Novo Nordisk is committed to have results from all clinical research activities published in a medical journal in accordance with international guidelines. In addition Novo Nordisk has a program for sharing anonymised data with external researchers.
     
    See how we share our clinical trial results

  • Ensure continuous evaluation of the quality of Novo Nordisk clinical research activities as well as instituting corrective and preventive actions when required. Clinical research activities are subject to internal audits and external quality inspections by Health Authorities.

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

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.

  • Adherence to ethical guidelines: Ensuring global adherence to ethical guidelines; Involving patients in drug development; Access to medicine/compassionate use (ie the strictly controlled use of unauthorised medicine in patients who have a disease with no satisfactory authorised therapies and who cannot enter clinical trials)
  • Vulnerable populations: Maintain focus on facilitating consent procedures for vulnerable patients, including children
  • Investigator-sponsored studies: Ensure full transparency in the financial transactions linked to investigator-sponsored studies
  • Social media use: Continue to evaluate the use of social media in clinical trials
  • Optimising Novo Nordisk's drug development: Ensure that any new clinical trial methodologies and technologies comply with our ethical ambitions
  • Real World Evidence: Ensure that new ways of collecting clinical data (real world evidence) comply with our ethical standards
  • Increase trust through transparency on clinical trials for trial participants and investigators: Enhance communication with participants in clinical trials; Enhance communication on clinical trials with investigators
  • Communicate the societal value of clinical trials and outcomes within diabetes

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.

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.

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.