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 efficacy and safety 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. Novo Nordisk addresses ethical concerns by applying the same ethical standards globally 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 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 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). 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.
Ensure that Novo Nordisk employees do not participate in Novo Nordisk sponsored clinical research.
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 publically 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.
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.
External clinical research governance system
Peter Billeskov Schelde
Corporate Project Vice President