Clinical trials

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Clinical trials

For many years Novo Nordisk has been incorporating ethical guidelines and practices into the procedures that govern the way the company conducts clinical research. Novo Nordisk applies the same procedures for sponsored clinical trials anywhere in the world. This means that all participants enrolled in Novo Nordisk trials are protected by the same rights, high ethical standards and regulations irrespective of the location of the study.

Performance 2008

Activities in 2008 include:

Trial registry

Since 2005 Novo Nordisk has made publicly available the results from all sponsored phase 1-4 interventional trials for marketed products. In 2008 Novo Nordisk added information on phase 1 trials and observational studies to the clinical trial web-site, which provides an overview of all (phase 1-4) Novo Nordisk sponsored clinical trials. This website also includes advanced search facilities and a description of Novo Nordisk’s ethical standards.

All trials registered at www.novonordisk-trials.com are also available from www.clinicaltrials.gov, a US government site. This site also includes additional trial protocols registered by independent researchers mentioning Novo Nordisk as a contributor to the trial.

Information about Novo Nordisk trials for marketed products is also available here.
Novo Nordisk has implemented a global Standard Operating Procedure (SOP) for registration of clinical trial results to ensure timely and consistent disclosure of information.

Recruitment of trial participants

In 2008, more than 14.000 subjects in 46 countries were involved in Novo Nordisk-sponsored clinical trials. Around 40 percent of the people involved live in developing countries.

Novo Nordisk follows the same high ethical standards for the recruitment of participants wherever trials are conducted. In accordance with Good Clinical Practice (GCP), which governs all of the clinical trials Novo Nordisk conducts, the interest and the well-being of the trial participants must always prevail over the interests of science, society and commerce.

Read more here.

Novo Nordisk has established a guideline for initiation of core trial activities in countries not on the current roster of participating nations. Among other things, the guideline stipulates that investigators must be experienced and trained in clinical trial activities, and ethical committees must be present and appropriately trained. Novo Nordisk staff must also be available to monitor the progress of all trials taking place.

Post-marketing studies

Studies involving products already on the market, also referred to as phase 4 trials, are becoming increasingly common; health authorities sometimes require so-called Post Marketing Surveillance (PMS) studies comparing the effects of one marketed product to another as part of a conditional approval. Another type of post-marketing activity is the Clinical Experience Programme (CEP), which examines the effects of a single product in large numbers of patients.

Such studies, while not conducted according to clinical interventional protocols, can provide good epidemiological data, including information on rare side effects. For such activities Novo Nordisk also adheres to international guidelines which were recently revised and implemented in Novo Nordisk’s Standard Operation Procedures.

Global ethical practices

A substantial part of Novo Nordisk’s clinical trials take place in the developing world. Novo Nordisk recognises that clinical trials carried out in developing countries have prompted media debate over the ethical conduct of these trials. However, all persons enrolled in Novo Nordisk-sponsored trials are protected by the same rights, high ethical standards and regulations, regardless of whether they live in the developed or the developing world.

All clinical trials Novo Nordisk is sponsoring will always be 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.

In year 2008, an external audit of Novo Nordisk’s bioethics system was undertaken by PricewaterhouseCoopers and the Werner Group. The conclusion was that “Novo Nordisk has an outstanding bioethics program and should be commended for its approach. The company’s emphasis on these issues, development of specific policies, and its governance structure designed to ensure that bioethics matters are incorporated into business decisions make the Company a leader in the pharmaceutical industry. Moreover, Novo Nordisk’s policies relating to ethical clinical trials are thorough and in many ways represent industry best practices. They are consistent with the Declaration of Helsinki, the Nuremberg Code and other important statements.”

Furthermore, Novo Nordisk has issued a brochure on clinical trials, ‘A responsible approach to clinical trials’, to inform interested parties how and why clinical trials are performed and the governance structure behind Novo Nordisk sponsored clinical trials to ensure the safety and integrity of persons involved in the studies.

Read more here.

The need for global trials

Novo Nordisk’s clinical trials are being performed globally in consequence of local regulatory requirements and need for global representation in study populations. Clinical trials in developing countries often raise ethical dilemmas concerning the people involved. Novo Nordisk only 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.

Read more here.

Informed consent

All Novo Nordisk-sponsored clinical trials are conducted according to the Declaration of Helsinki describing human rights for patients participating in clinical trials and similar international guidelines.

Clinical trials sponsored by Novo Nordisk are initiated upon approval from external ethics committees and health authorities and are conducted according to scientific principles and only when medically justified.
Read more here.

Novo Nordisk’s approach

Novo Nordisk fully supports transparency of clinical trial results and is committed to a high ethical standard in all aspects of conducting clinical trials. For us, this is a matter of being respectful of the integrity of people participating in clinical trials.

Read more here.

Novo Nordisk's approach to ethical issues in relation to clinical trials is compiled at Novo Nordisk’s clinical trials web-site, a site that also provides an overview of Novo Nordisk’s clinical trial programmes worldwide.

Read the Novo Nordisk’s position on clinical trials.

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