Clinical trials
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.
Global ethical practices
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 person 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 and Novo Nordisk’s own internal Standard Operating Procedures and policy on ethical conduct of clinical trials. Trial activities only start after approval from an external local ethical committee and no procedure involving a person undergoing clinical trials will take place before the person has given informed consent. 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 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 being involved in clinical trials also require expanding the global recruitment base.
Informed consent
Novo Nordisk ensures that the people participating in the 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 takes care to make sure that literacy, poverty, or cultural barriers do not prevent a person’s full understanding of the issues involved in participating in a clinical trial. A trial participant can withdraw at any time without providing a reason.
Novo Nordisk also does 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 that is for research purposes at the given hospital. GCP prohibits companies conducting clinical trials from paying patients directly for participation in a trial.
Novo Nordisk will continue to adhere to the highest ethical standards regarding clinical trials.
Performance 2004
In 2004, the issue of transparency over clinical trial results came to the forefront following some highly publicised cases in which some pharmaceutical companies were accused of suppressing negative results from clinical trials.
In September 2004, the International Committee of Medical Journal Editors (ICMJE), a group that includes leading medical journals, took a public stand on the question. It announced its members would soon refuse to publish the results of any clinical trial that had not been registered at the outset in a public database.
At almost the same time, the Pharmaceutical Research and Manufacturers of America (PhRMA), required that members should post summaries of their trial results on their website, the Clinical Study Results Database.
In response, Novo Nordisk – which is a PhRMA member – will in 2005 begin publishing the results of all clinical trials of its marketed products in the PhRMA public database, in accordance with PhRMA’s proposed requirements.
It will also publicly report the initiation of all new phase 2, 3 and 4 clinical trials in a public trial registry, in accordance with the ICMJE requirements.
Finally, Novo Nordisk is continuing to seek publication of all clinical trial results in peer-reviewed medical journals and/or at scientific meetings in accordance with the Helsinki declaration. This is part of the company’s long-standing Standard Operating Procedure regarding publication of clinical testing.
