Clinical trial ethics


Novo Nordisk sponsors clinical research globally either in the form of interventional clinical trials or as non-interventional studies. Both activities are carefully designed to evaluate the effects of an investigational or approved medication or a new device, which can lead to improvements in people’s health.

Interventional clinical trials are important steps in the research and development process. A potential new medicine’s ability to treat a condition, its safety and its possible side effects must be assessed in controlled experimental settings involving both healthy volunteers and patients before marketing authorisation may be granted by authorities.

Following granting of marketing authorisation Novo Nordisk may sponsor additional interventional clinical trials to investigate and document the safety and efficacy of new indications or to support expansions in the use of the medication in the approved indication. Authorities may also require additional interventional trials to further investigate and document the long-term safety of a product.

After marketing authorisation of a product Novo Nordisk may further be asked to undertake additional study programs to gain information about the medicine when used in daily clinical practice. This may be done through collecting data on healthcare outcomes in a “real life” setting. These study programmes may include non-interventional studies, registry studies and patient/healthcare provider surveys. Non-interventional studies are often conducted in collaboration with general practitioners and constitute an important scientific tool to collect additional information, especially on adverse events of a given drug in clinical use.

It is anticipated that in the coming years an increasing number of Novo Nordisk-sponsored clinical research activities will be conducted as a result of our expanding development pipeline and increasing global and local regulatory requirements. We support global exposure of investigational drugs to be able to observe efficacy and safety in different ethnic, therapeutic and cultural settings. We are committed to sharing knowledge and the company transparently communicates the results of clinical trials, regardless of outcome. Results are communicated on public websites, in scientific journals, at scientific meetings, or by other means.

There are important ethical implications of testing investigational medicines on people. Specific concerns have been raised related to clinical research performed in developing countries and it has been argued that some parts of the pharmaceutical industry are taking advantage of poor and illiterate people by undertaking research in developing countries that is not acceptable in more developed countries. Another concern relates to whether or not the investigational medicine will be made available to the population participating in the clinical research activities.

Novo Nordisk addresses these and other ethical concerns by applying global ethical principles and proper scientific and statistical methods, as well as adhering to global and local regulatory requirements in all our clinical research activities. As examples, Novo Nordisk always ensures a proper selection of people enrolled, minimisation of the risk/benefit ratio for the study participants, proper informed consent procedures, and independent ethical approval of all study protocols. Furthermore, we only do trials in countries where we intend to market the investigational drug.

Novo Nordisk’s position

  • Clinical research sponsored by Novo Nordisk will always comply with applicable external guidelines and regulations having their origin in the Nuremberg Code, the Declaration of Helsinki (which describes human rights for patients participating in clinical research), other internationally accepted ethical guidelines, local laws, and the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP), Good  Pharmacoepidemiology Practices (GPP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). Furthermore, we will comply with all local regulations in the countries where we do clinical research. 
  • The above guidelines and regulations are the foundation for Novo Nordisk’s clinical Standard Operating Procedures (SOPs) including a ‘Principles of clinical research’ SOP. These standards are applied globally and laid out to ensure that the safety, rights, integrity, confidentiality and well-being of people enrolled in Novo Nordisk trials will always prevail over the interests of science, society and commerce. 
  • Novo Nordisk respects that clinical research activities should only be conducted if they are scientifically, medically and ethically justified. Clear and detailed protocols are always prepared before initiation of any clinical research activity.
  • Novo Nordisk ensures that protocol information for all Novo Nordisk-sponsored trials is registered in publicly accessible databases according to requirements, before recruitment of any study participants.
  • No research activity in Novo Nordisk-sponsored trials will start before approval is obtained from Independent Ethics Committees (IEC) or Institutional Review Boards (IRB) as applicable, as well as from the responsible Regulatory Authorities.
  • Before any clinical research activities can take place, freely given informed consent based on appropriately provided information must be obtained from the people enrolled.
  • Special consideration is given to vulnerable patient populations (including but not limited to children and the elderly). In clinical research involving minors, processes for seeking informed consent from the minor or the minor’s legally authorised representative will be described in the protocol.
  • Novo Nordisk will only conduct placebo-controlled research activities if scientifically and ethically justified, and study participants will always be informed about potential implications of the placebo treatment before enrolment.
  • Patients may receive compensation for documented expenses related to trial participation, while healthy volunteers in addition may receive financial compensation for inconvenience/discomfort related to the clinical research activity. All financial compensation, including investigator’s fee, shall be in accordance with local regulations and must be approved by the IRB/IEC when required.
  • Novo Nordisk does not allow its employees to participate in clinical trials assessing efficacy and safety of Novo Nordisk investigational products due to high risk of bias.
  • Staff and investigators involved in conducting Novo Nordisk-sponsored clinical trials must always be appropriately qualified.
  • Research activities will only take place in countries where the regulatory environment, infrastructure, medical standards and Independent Ethics Committees (IEC) or Institutional Review Boards (IRB) as appropriate are all adequate. Furthermore, Novo Nordisk only conducts trials in countries where we intend to market the investigational product.
  • Investigational pharmaceuticals used in Novo Nordisk-sponsored clinical research will be manufactured and controlled according to international GLP and GMP guidelines and meet all local standards.
  • Novo Nordisk fully respects that people enrolled in clinical research can withdraw at any time during a research activity without providing any reason.
  • Novo Nordisk protects the privacy of research participants by safeguarding the use of sensitive personal data with appropriate security measures. We only use personal information for legitimate purposes known to the individual whose data we are processing.
  • Novo Nordisk ensures that relevant patient safety information is continuously assessed during Novo Nordisk-sponsored research activity and that appropriate actions are taken if the risk of the trial product outweighs the potential benefits.
  • Novo Nordisk will ensure proper indemnification of research participants in case an investigational pharmaceutical or procedures in Novo Nordisk-sponsored research cause bodily harm to a research participant.
  • Research participants enrolled in a Novo Nordisk-sponsored interventional trial will after trial completion be offered the best possible and available treatment at the discretion of the investigator. Access to post-study trial medication will be described in the protocol and informed consent. Investigators may under special circumstances apply for use of a medication which has not yet obtained marketing authorisation approval, on a named patient basis.
  • Novo Nordisk will ensure accurate and timely recording, verification, handling, interpretation, and reporting of all data and results from all Novo Nordisk-sponsored clinical research activities in accordance with current international guidelines and global and local requirements.
  • Novo Nordisk publishes all trial results regardless of outcome in public databases according to global and local requirements and strives for publication in scientific journals.

Novo Nordisk’s clinical research governance system

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.

  • All new external guidelines are reviewed and implemented into SOPs as required.
  • No clinical research activity in people will take place before approval by the Novo Nordisk Safety Committee, where all preclinical findings are assessed and reviewed.
  • All Clinical Development Plans are reviewed and approved by an internal international challenge board including senior people with competencies within the therapy area.
  • All protocols and amendments are approved by a review committee with representatives from the involved functions within the company.
  • Novo Nordisk only permits research activities to take place in countries that can fulfil internal (resources, competencies and existence of an appropriate quality system) and external (regulatory and infrastructure) requirements.
  • Feasibility and patient allocation are decided by an international group who must ensure that patient recruitment only happens in countries that can - and do - meet the above necessary quality and ethical requirements.
  • All studies are monitored frequently by trained personnel with documented competencies and according to the same standards everywhere.
  • Safety committees are established for all Novo Nordisk clinical research activities to follow up and take immediate action if needed on any safety aspects of our research activities. 
  • A cross-functional review committee approves all study reports. 
  • Research activities are audited by the internal Clinical Quality Assurance function.

External clinical research governance system

  • All protocols include information about informed consents and payments to investigators and must be approved by an IEC or an IRB as applicable, as well as Regulatory Authorities. 
  • In all trials both sponsor and trial sites can be audited at random by local health authorities and local ethics committees to ensure that regulations, GCP and protocols are adhered to. 
  • Novo Nordisk Global Development is certified according to the International Organization for Standardization (ISO) quality standard and accordingly audited on a regular basis.

For further reading about our approach to clinical trials please see clinical trials web-site and our brochure ‘A responsible approach to clinical trials’.

References
1. Declaration of Helsinki 
2. Nuremberg Code
3. ICH GCP 

 

Updated 17 December 2012