Details

Autor(en) / Beteiligte

• Ronowicz, Joanna

Titel

The specificity of non-commercial clinical trials with the participation of medical universities

Ist Teil von

• Farmacja Polska, 2019-12, Vol.75 (10), p.584-588

Ort / Verlag

Polish Pharmaceutical Society

Erscheinungsjahr

2019

Link zum Volltext

Quelle

EZB Free E-Journals

Beschreibungen/Notizen

• Non-commercial clinical trials play an increasingly essential role for global health. Thanks to them a progress of knowledge in medical and health sciences is possible. Non-commercial clinical trials are conducted without the participation of pharmaceutical companies, mainly in order to evaluate the effectiveness and safety of drug products already used in the pharmaceutical market. These studies are usually initiated by researchers working at medical universities and they are conducted in clinical hospitals. The Pharmaceutical Law states that the data obtained in non-commercial clinical trials cannot be used for marketing purposes and for changes to existing marketing authorizations. Non-commercial studies are usually carried out with the use of already registered drug products, but used in different dosages, different patient groups (eg. pediatric) or in another application. Non-commercial research leads to the development of new treatments for rare diseases which are rarely in the interest of pharmaceutical companies. This approach allows to broaden the knowledge of medicines, find a new application or a more effective dose. In Poland, non-commercial clinical trials constitute ca. 2-5% of all registered research. In the Western European countries, this rate is much higher (20-25%). There are many difficulties in undertaking independent clinical research without support from the pharmaceutical industry. There is a need to support non-commercial clinical trials addressed to relevant questions about public health and clinical decisions. In Poland, more funding for non-commercial research is still needed. In February 2019, the Medical Research Agency was established as the institution responsible for the development in the field of medical and health sciences. It can be a significant step to support non-commercial clinical trials and consequently it may open access to advanced modern pharmacotherapies for patients or reduction in the cost of treatment of selected diseases.