Clinical trial ethics
Clinical trials sponsored by Novo Nordisk are always conducted according to the Declaration of Helsinki describing human rights for patients participating in clinical trials.
The accepted way in the pharmaceutical industry to ensure compliance with international declarations, guidelines and legislation is to have a system of Standard Operating Procedures (SOP).
Health authorities inspect Novo Nordisk trial processes in relation to compliance with these procedures. Novo Nordisk ensures the following ethics procedures are in place:
Before the initiation of a clinical trial
- Approval by applicable ethics committee and health authorities
- Informed consent will be obtained from all trial participants
- Pre-trial visits to ensure the investigational site has the required facilities and resources to ensure compliance with Good Clinical Practice (GCP) requirements
During the course of a clinical trial
- Procedures for reporting of adverse events by the responsible physician to Novo Nordisk and health authorities
- Auditing of trial sites and clinical trial processes by Novo Nordisk Quality organisation to ensure the conduct of the clinical trials meets the requirements.
After completion of a clinical trial
- The investigator is informed about the results of the clinical trial. It is subsequently the responsibility of the trial physician to inform the trial participant.
Clinical trials are performed globally
Novo Nordisk conducts clinical trials in countries where the company intends to market the investigational medicinal product. Health authorities have specific requirements for the industry to do this.
Novo Nordisk only conducts trials in countries where it can ensure that Novo Nordisk clinical trial standards are met.
Safety for Participants
Novo Nordisk's obligations as the trial sponsor
It is the responsibility of the clinical trial sponsor, ie Novo Nordisk, to ensure the physician conducting the clinical trial is skilled in the therapeutic area, is trained in the principles governing the conduct of clinical trials (GCP), and has access to the necessary equipment, time and resources for conducting the trial.
The products used in a clinical trial are manufactured and controlled according to international and local laws and regulations.
Novo Nordisk personnel will visit the trial sites frequently to monitor and ensure the trial is executed according to the trial protocol (which is approved by an ethics committee and health authorities).
It is the obligation of Novo Nordisk as a sponsor to ensure that available information about the trial product is submitted to the physician and health authorities, and that the information is updated when new information becomes available.
The physician responsible for the trial has the obligation to ensure and protect the interests of the trial participant. Before the initiation of any trial activity, the trial participant must give his or her informed consent.
If a trial participant experiences an adverse event, the physician responsible for the trial must be notified in order to ensure that adequate medical care is provided. The responsible physician will monitor closely and report to the trial sponsor / health authorities any adverse event that occurs during the course of the trial irrespective of whether the event is considered related to the trial product.
Safety monitoring in clinical trials
Novo Nordisk has established safety committees for all investigational medicinal products that follow the reporting of adverse events globally. It is the responsibility of the safety committee to take immediate action if needed on safety aspects.