Nowadays,\nmuch clinical research takes place simultaneously in several countries. The\nmajority of the clinical trials that form the basis of authorisation dossiers\nfor the therapeutic products agency Swissmedic are carried out in the USA and\nthe EU. <\/p>\n\n\n\n
The\nnumber of clinical trials performed in countries with an emerging economy has\nincreased in recent years, for both regulatory and medical reasons. In some\ncases, there are medical advantages to running a trial in different\npopulations. Moreover, some diseases only occur in certain parts of the world,\nmeaning that the corresponding medicinal products can only be tested there. The\nimproved medical infrastructure, with increasingly well-trained healthcare\nprofessionals, also plays an important role.<\/p>\n\n\n\n
No\nmatter where a clinical trial is carried out, the international standards of\nGood Clinical Practice (GCP) developed by the International Conference on\nHarmonisation (ICH) and based on the Declaration of Helsinki always apply. In\nSwitzerland, only authorisation dossiers containing GCP-compliant clinical data\nmay be submitted to Swissmedic, the regulatory authority. The pharmaceutical\ncompany is required to demonstrate that its clinical trials have been carried\nout in accordance with GCP standards. Otherwise, the trials will not be\naccepted as the basis of a product authorisation and are thus useless. A\nsimilar rule \u2013 known as the equivalence rule \u2013 applies in the EU, where the\nEuropean Medicines Agency EMA decides on the authorisation of medicinal\nproducts.<\/p>\n\n\n\n
Among\nother things, the GCP rules require the following: written informed consent\nmust be obtained from every participant, there must be no coercion to take\npart, the relationship between benefit and risk for participants must be\nfavourable, and every trial must be reviewed by an independent Ethics Committee\nbefore it can be carried out.<\/p>\n\n\n\n
In\naddition to the GCP requirements, clinical trials are also governed by the\nInternational Ethical Guidelines for Biomedical Research Involving Human\nSubjects compiled by the Council for International Organizations of Medical\nSciences (CIOMS). Furthermore, the Convention on Human Rights and Biomedicine,\nalso known as the Biomedicine Convention, has been in force since 1997. It\nestablishes minimum standards for the protection of human rights and dignity in\nthe context of biology and medicine. The Convention entered into force for\nSwitzerland in 2008. In 2005, the Council of Europe also published the\nAdditional Protocol to the Biomedicine Convention; this covers research\nactivities involving interventions on human beings. The basis for ratifying\nthis Convention in Switzerland was created by the new Article concerning human\nresearch in the Constitution and the Human Research Act.<\/p>\n\n\n\n
Many\npharmaceutical companies go even further and have developed their own\nguidelines, according to which clinical trials may only be carried out in\ncountries in which the medicinal products in question will be marketed,\nprovided they are shown to be safe and effective. In addition, access to vital\nmedicines is guaranteed beyond the end of the trial. This enables the\npopulation in the region to benefit directly from these clinical trials.<\/p>\n","protected":false},"excerpt":{"rendered":"
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, […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":4214,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-templates\/unterthema.php","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-4034","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\n