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Clinical trial ethics

Clinical trials are controlled experimental settings in human beings intended to test a medical hypothesis involving clinical, pharmacological, other pharmacodynamic effects, and/or to identify any adverse reactions to investigational drugs. Clinical trials evaluate interventions that could lead to improvements in health and should be conducted in an ethically fair manner. This implies applying proper scientific principles and methods, making proper subject selection for study participation, minimising the risk/benefit ratio of the trial participants, ensuring independent review and informed consent, and showing respect for the individuals who are potential and enrolled study subjects.

Novo Nordisk conducts clinical trials globally to test the safety and efficacy of new drug candidates in order to obtain global marketing authorisation. Furthermore, Novo Nordisk sponsors clinical trials after approval to market a drug has been granted in order to gain more clinical knowledge and experience of the products. To perform clinical trials properly, numerous methodological, statistical, regulatory and ethical principles need to be applied. Below is an overview of some of the ethical pitfalls and Novo Nordisk’s position on how these challenges should be addressed in order to be in compliance with existing regulations in this area and with Novo Nordisk’s principles for responsible business practices.

The World Medical Association has developed the Declaration of Helsinki and its amendments as a standard of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Together with other international guidelines incl. the Belmont report, the Nuremberg Code and CIOMS (WHO) international ethical guidelines for biomedical research involving human subjects, and international guidelines in good clinical practice (GCP) it serves as the primary point of reference when Novo Nordisk sponsors clinical trials. This is reflected in our global Standard Operating Procedures (SOPs) for clinical trials.

The ethical aspects of clinical trial activities, particularly when sponsored by pharmaceutical companies, sometimes cause media debate. Concerns refer to issues such as principles for recruitment of patients, respect of patients’ right, the countries where the trials are performed and potential bias in publication of results. There are indeed ethical implications of involving diseased persons in the testing of compounds that potentially represent large financial revenues to the sponsor. The concerns are further aggravated when trials are performed in developing countries where the perception by some – based on unfortunate examples - is that the pharmaceutical industry takes advantage of poor and illiterate people, and undertakes trials that would not have been permitted under the ethical standards in developed countries. Further allegations are that trials are undertaken in developing countries with a risk of participating in unethical practices, or even bribery, and that when compounds are brought to market they are only available in developed countries at a significant profit, without offering the drug to the countries initially involved in their development.

Novo Nordisk supports enhanced global exposure of investigational products. Novo Nordisk conducts research in therapies that require global trials and inclusion of different ethnic populations. The company also anticipates a need to conduct an increasing number of clinical trials as a reflection of the expanding pipeline and local regulatory requirements. Novo Nordisk’s ethical principles, which apply globally, ensure due respect for the safety, rights, integrity, dignity, confidentiality and well-being of human beings participating in Novo Nordisk-sponsored trials.

Novo Nordisk’s position

• Clinical trials sponsored by Novo Nordisk will always be conducted according to the Helsinki Declaration, which describes human rights for patients participating in clinical trials, and similar international ethical guidelines such as the Nuremberg code, the Belmont report and CIOMMS, and the International Conference of Harmonisation (ICH) guidelines for current good clinical practice (cGCP).
• The above guidelines and regulations are the foundation for our clinical Standard Operating Procedures (SOPs) including the SOP on the ‘principles of clinical trials’. These standards are laid out to ensure the safety, rights, integrity, confidentiality and well-being of persons involved in Novo Nordisk trials globally.
• Novo Nordisk will apply the same procedures wherever we sponsor clinical trials. This means that all subjects enrolled in Novo Nordisk trials are protected by the same rights, high ethical standards and regulations irrespective of location of the study.
• The interest and well-being of the trial subject should always prevail over the interest of science, society and commerce.
• Novo Nordisk will not conduct clinical trials for drug development in countries where we do not intend to market the investigational drug. In any country where we do undertake clinical trials we will ensure that a proper internal organisation and a proper regulated external environment exist.
• Clinical trials should only be done if they can be scientifically and medically justified, and all Novo Nordisk-sponsored trials should be based on sound scientific methodology described in a clear and detailed protocol. Placebo will only be used as comparator when scientifically and ethically justified
• No trial activity in Novo Nordisk-sponsored trials will start before approval is obtained from external local ethics committees and health authorities.
  We will always ensure that investigators involved in Novo Nordisk clinical trials are skilled in the therapeutic area and are trained in GCP. No procedure involving a person undergoing clinical trial activities will take place before the appropriate freely given informed consent is obtained based on proper information on potential risk of participation in the trial. A patient can at any time withdraw from a clinical trial without giving any reason. In cases where trial subjects are incompetent, physically or mentally incapable of giving consent, or if the person is a minor, Novo Nordisk will follow local regulations for obtaining consent.
• Products used in Novo Nordisk-sponsored clinical trials will be manufactured and controlled according to international and local regulations and laws.
  Novo Nordisk will conduct frequent site monitoring to ensure that the study is executed according to the study protocol, and that data used in statistical analysis and reporting reflects the data obtained from the involved patients during the trial.
  Safety information from any Novo Nordisk trial will be monitored on a continuous basis and appropriate actions will be taken if risks of the investigational product outweigh the potential benefits.
• Patients participating in Novo Nordisk-sponsored clinical trials will always be offered best available and proven treatment after study termination. The treatment will be offered at the discretion of the responsible physician. If study medication is not marketed the responsible physician can apply for medication on a named patient basis. Post-study medication will be described in the protocol and informed consent.
• Novo Nordisk will ensure proper indemnification of trial subjects in case a trial product or procedures in a Novo Nordisk-sponsored trial cause bodily harm to a trial subject.
• Novo Nordisk strives to have all clinical trial results published according to accepted international guidelines, and we will always ensure transparency of our studies by publishing protocol synopses on the external website: www.clinicaltrials.gov. Study results from trials involving marketed drugs can be accessed via www.clinicalstudyresults.org. Furthermore, Novo Nordisk has its own online repository for clinical trials activities: novonordisk-trials.com. Novo Nordisk is collating all information about bioethics in the R&D area on www.novonordisk.com/R&D/bioethics.

The governance system of clinical trials

Novo Nordisk has a well-organised structure in place which ensures that current directives and external guidelines are adhered to and that key activities are approved by senior management.

• All new external guidelines are scanned by an external affairs clinical board and implemented by our SOP committee into Standard Operating Procedures as required.
• No clinical trial activity in human beings will take places before approval by the Novo Nordisk Safety Board where all preclinical findings are assessed and reviewed.
• All Clinical Development Plans including trial synopses are reviewed and approved by an international internal challenge board with global management representation, and plans are endorsed by Development Portfolio Committee with members from Executive Management in Novo Nordisk.
• All protocols and amendments are approved by the Protocol Review Committee chaired and manned by vice presidents from involved functions within the company.
  Countries are only allowed to do clinical trials when they fulfil internal (resources, competencies and existence of an appropriate quality system) and external (regulatory and infrastructure) requirements.
• Feasibility and patient allocation will be decided at the International Clinical Operation Forum meetings to ensure that patient recruitment only happens in countries that are able to and do live up to the needed requirements.
• All studies are monitored frequently by trained Novo Nordisk personnel with documented competencies. If monitored by contract research organisations we ensure that these are competent to do the monitoring according to our standards.
• Safety committees are established for all Novo Nordisk clinical trials and projects to follow up and take immediate action if needed on safety aspects in a given trial or project.
• The Report Review Committee approves all Integrated Trial Reports and Integrated Summaries.
• All trial activities are randomly audited by the internal Clinical Quality Assurance.
  External governance bodies exist as well:
• All protocols including informed consents and payments to investigators must be approved by local ethics committees and health authorities.
• In all trials both sponsor and trial sites can at random be audited by local health authorities and local ethics committees to ensure that GCP is adhered to.
• Furthermore, Novo Nordisk Global Development is certified according to the ISO quality standard and accordingly audited on a regular basis.

References

1. Helsinki Declaration: http://www.wma.net/e/policy/b3.htm
2. CIOMS: http://www.cioms.ch/frame_guidelines_nov_2002.htm
3. Nuremberg Code: http://ohsr.od.nih.gov/guidelines/nuremberg.html
4. Belmont: http://ohsr.od.nih.gov/guidelines/belmont.html
5 GCP ICH: http://www.emea.eu.int/pdfs/human/ich/013595en.pdf

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