Clinical Trials in developing countries
Novo Nordisk makes sure that illiteracy, poverty or cultural barriers do not prevent a person’s full understanding of the consequences of participating in a study. And the company only initiates trials in countries that can provide approval from an external local ethical committee and governmental body.
Interview with Anders Dejgaard, Novo Nordisk Chief Medical Officer
- Why does Novo Nordisk conduct clinical trials in developing countries?
- We conduct our trials globally because we need to test our products in the populations where the products are going to be marketed. Often the countries' regulatory authorities require us to do this. The limited numbers of patients who are willing and suitable for being involved in clinical trials and our increasing need to carry out clinical trials also require us to expand our global recruitment base. Physicians in developing countries also wish to be part of our trials because they want to be involved in the front line of research.
- How does Novo Nordisk make sure that doctors are qualified to perform clinical trials?
- Novo Nordisk employees always arrange pre-study visits to ensure we are in compliance with the requirements of GCP (Good Clinical Practice). In addition, Novo Nordisk often provides full GCP training of investigators in relation to the start of trials. According to GCP, Novo Nordisk is required to ensure and document that all involved investigators are qualified to carry out the trial before any trial-related activities are started.
- To what extent does Novo Nordisk pay doctors and patients to participate in clinical trials in developing countries?
- Doctors are only paid to compensate for their work associated with a given trial. Most often payments are made to a fund for research purposes at the hospital and not to the doctor himself. Financial agreements with investigators must be approved by ethical committees. Novo Nordisk lives up to GCP, clearly stating that it is not allowed to pay patients for participation in a trial.
- How do you make sure that patients fully understand the conditions for the clinical trial?
- Information about a clinical trial is always given in the patient's native language. By doing this we ensure that literacy, poverty or cultural barriers do not prevent a person's full understanding of the issues involved in participating in a clinical trial. Participation in a trial is always voluntary, based on informed consent, with the ability to withdraw at any time without giving a reason.
- Do you perform trials in developing countries because of reduced regulatory and ethical demands?
- No. We have global guidelines with requirements on resources, quality systems and competences in the local Novo Nordisk organisation. We also have guidelines for the infrastructure and existence of ethical committees in any country that is involved in conducting clinical trials for Novo Nordisk.
- Does Novo Nordisk perform clinical trials without approval from ethical committees?
- No, we only perform trials that are approved by local ethical committees. This also means that we only perform trials in countries where such a system is established. Ethical committees are constituted in accordance with the ICH guidelines, having independent board members and comprising physicians as well as lay persons. The mandate of the ethical committees is specifically to ensure that the given ethical codes are adhered to. Health authorities conduct inspections of clinical trials, covering both investigators (external physicians that perform the studies) and companies, to ensure that trials are conducted in accordance with the Helsinki Declaration and the ICH guidelines.
- Will all patients sign an informed consent form – and what if they are unable to do so?
- Patients in Novo Nordisk trials will always sign an informed consent form. Patients who are unable to give their consent due to physical or mental impairment or being under age will only be included in a study activity if consent procedures for these groups of people, in accordance with local regulations, are followed. When the patient is able to do so, he or she will be asked to sign an informed consent form.
- According to the Helsinki Declaration everyone who participates in a trial should be offered the best available treatment afterwards. How do you deal with this in developing countries where the medicinal product will not be marketed due to high prices?
- Novo Nordisk will only perform clinical trials in countries where we intend to market the investigational medicinal product. However, the decision to market the compound is – among other things – based on the outcome of the clinical trial development programme for phases 1 to 3A. The very purpose of these trials is to see if the medicinal product is efficacious and safe. The medicinal product is by definition not available until regulatory authorities have approved our filings.
For all trials we will describe what medication patients can be offered after the study. Phase 3B trials will only be executed in countries where we believe the medicinal product will be marketed. This is ensured by an internal international committee when allocating patients to a given study. Phase 4 trials will by definition only be undertaken with marketed available medicinal products in a given country, which can accordingly be offered to the patient after the trial is finalised. If a patient is assessed by a treating physician as being dependent on a given investigational medicinal product that is not marketed in his or her country, the patient can receive the medicinal product on a so-called "named patient" supply basis.
- The Helsinki Declaration says that placebo should only be used if no other “proven comparator” exists. Does Novo Nordisk use placebo as a comparator?
- The World Medical Association (WMA) issued a note of clarification to this paragraph, saying that if for compelling and scientifically sound methodological reasons placebo use is necessary, placebo-controlled trials may be ethically acceptable. Novo Nordisk fully agrees with and lives up to this clarification.