Clinical trials

In recent years there has been growing focus on the conduct and transparency of clinical trials within the pharmaceutical industry. The industry is suspected of not making all results publicly available from its clinical trials, particularly results compromising the market value of its products. The International Committee of Medical Journal Editors (ICMJE), among others, has called for greater transparency of clinical trial results, arguing that full disclosure of clinical trial results ensures that the public can find key information about every clinical trial whose principal aim is to shape medical decision-making.

In September 2004 the ICMJE announced that its members would only publish clinical trial results from clinical trials that had been registered in a public database at their inception.
The National Institutes of Health (NIH) in the US extended their site for use on a global scale; see www.clinicaltrials.gov. Additionally, the Pharmaceutical Research and Manufacturers of America (PhRMA), an industry association, established a site for member companies to hold clinical information and references to publications for trials finalised after 1 October 2002 for marketed products, the Clinical Study Results Database.

The industry has responded to these requests for more transparency, but some stakeholders still consider the response inadequate to safeguard public health. This will be an issue of ongoing concern, not only for the industry, but also for society at large. While regulatory authorities monitor that research is conducted in accordance with relevant laws and universal principles, stakeholders also seek reassurance that the companies consider any ethical concerns that may emerge.

Novo Nordisk conducts clinical trials globally in order to test the safety and efficacy of new drugs before marketing. 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 these products. We fully support transparency of clinical trial results and are committed to a high ethical standard in all aspects of conducting clinical trials. For Novo Nordisk, this is a matter of being respectful of the integrity of people participating in medical studies.

Novo Nordisk conducts clinical trials in Europe, Asia, Japan, North America, South America, Eastern Europe and certain African countries. About 15% of the trials take place in the developing world. We recognise that clinical trials held in developing countries have prompted media debate over the ethical conduct of these trials. For Novo Nordisk, there is no ethical conflict over the way we conduct clinical trials in the developing world as opposed to the developed world. All persons enrolled in Novo Nordisk-sponsored trials are protected by the same rights, high ethical standards and regulations irrespective of which country they are in. The clinical trials that Novo Nordisk sponsors are conducted according to:

• the World Medical Association's Helsinki Declaration describing human rights for patients participating in clinical trials 
• the International Conference on Harmonisation (ICH) for current Good Clinical Practice (cGCP) 
• local regulatory guidelines 
• Novo Nordisk's own internal Standard Operating Procedures and policy on ethical conduct of clinical trials.

Other ways in which ethical conduct is assured before the start of any trial or procedure:

• Approval of external local ethical committee 
• Informed consent of trial participants

Novo Nordisk personnel audit trial sites on a regular basis to ensure that these guidelines are met.

Novo Nordisk conducts clinical trials globally because it is necessary to test products in the populations where the product is going to be marketed. Indeed, often the countries' regulatory authorities often require pharmaceutical companies to do this. Physicians in the developing countries also wish to be part of Novo Nordisk trials in a desire to be involved in the front line of research. The number of patients who are willing and suitable for involvement in clinical trials also requires an expanding of the global recruitment base.

We ensure that the people participating in Novo Nordisk-sponsored trials are given detailed information, both verbally and in written form, about the purpose of the trial and the potential risks and benefits of participation. This information is always given to the patient in the patient's native language. The patient and the investigator need to sign the informed consent form to document that this has happened. Novo Nordisk ensures that literacy, poverty or cultural barriers do not prevent a person from fully understanding the issues involved in participating in a clinical trial. A trial participant can withdraw at any time without providing a reason.

We also do not conduct a trial unless the investigator or physician has the necessary skills and competence to perform the trial. The investigators are paid to compensate for their time, and most often this money is paid into a research fund for research purposes at the given hospital. GCP prohibits companies conducting clinical trials from paying patients directly for participation in a trial.

We will continue to adhere to the highest ethical standards regarding clinical trials.

In response to the issue of transparency of clinical trial results, Novo Nordisk complies with the ICMJE requirements and also posts its trial results on the PhRMA site. The ICMJE requires the registration of trials that started recruiting on or after 1 July 2005. Because many ongoing trials were not registered at inception, the ICMJE will consider for publication ongoing trials registered before 13 September 2005.

Novo Nordisk has met both deadlines, with 51 trials of marketed compounds registered at the NIH site by the end of 2005 and 73 trials posted on the PhRMA site. For all Novo Nordisk-sponsored clinical trials the investigator's right to publish the full results of the trial is acknowledged as a standard part of the trial protocol.

This page has been assessed by PricewaterhouseCoopers as part of its assessment of Novo Nordisk’s statement that it reports ‘in accordance’ with GRI. Please refer to Audit and assurance for a full description of the nature of assurance offered.