Nowadays, much clinical research takes place simultaneously in several countries. The majority of the clinical trials that form the basis of authorisation dossiers for the therapeutic products agency Swissmedic are carried out in the USA and the EU.
The number of clinical trials performed in countries with an emerging economy has increased in recent years, for both regulatory and medical reasons. In some cases, there are medical advantages to running a trial in different populations. Moreover, some diseases only occur in certain parts of the world, meaning that the corresponding medicinal products can only be tested there. The improved medical infrastructure, with increasingly well-trained healthcare professionals, also plays an important role.
Globally valid international standards
No matter where a clinical trial is carried out, the international standards of Good Clinical Practice (GCP) developed by the International Conference on Harmonisation (ICH) and based on the Declaration of Helsinki always apply. In Switzerland, only authorisation dossiers containing GCP-compliant clinical data may be submitted to Swissmedic, the regulatory authority. The pharmaceutical company is required to demonstrate that its clinical trials have been carried out in accordance with GCP standards. Otherwise, the trials will not be accepted as the basis of a product authorisation and are thus useless. A similar rule – known as the equivalence rule – applies in the EU, where the European Medicines Agency EMA decides on the authorisation of medicinal products.
Among other things, the GCP rules require the following: written informed consent must be obtained from every participant, there must be no coercion to take part, the relationship between benefit and risk for participants must be favourable, and every trial must be reviewed by an independent Ethics Committee before it can be carried out.
In addition to the GCP requirements, clinical trials are also governed by the International Ethical Guidelines for Biomedical Research Involving Human Subjects compiled by the Council for International Organizations of Medical Sciences (CIOMS). Furthermore, the Convention on Human Rights and Biomedicine, also known as the Biomedicine Convention, has been in force since 1997. It establishes minimum standards for the protection of human rights and dignity in the context of biology and medicine. The Convention entered into force for Switzerland in 2008. In 2005, the Council of Europe also published the Additional Protocol to the Biomedicine Convention; this covers research activities involving interventions on human beings. The basis for ratifying this Convention in Switzerland was created by the new Article concerning human research in the Constitution and the Human Research Act.
Further-reaching voluntary undertakings
Many pharmaceutical companies go even further and have developed their own guidelines, according to which clinical trials may only be carried out in countries in which the medicinal products in question will be marketed, provided they are shown to be safe and effective. In addition, access to vital medicines is guaranteed beyond the end of the trial. This enables the population in the region to benefit directly from these clinical trials.