Modern therapies in rheumatology: the role of clinical trials
Abstract
Recent decades have seen an increase in the effectiveness of therapies used. However, there are still many challenges facing modern medicine, including rheumatology. The development of modern therapies is made possible by large-scale clinical trials. Clinical trials are not only designed to verify the effectiveness of a therapy. They are also intended to assess the bioavailability, pharmacodynamics, metabolism, and elimination of therapeutic substances. In Poland, clinical trials have been conducted for many years. It is estimated that the costs currently borne by the sponsors of clinical trials in Poland amount to more than one billion per year. In rheumatology, clinical trials are important not only because of their scientific aspect, but also because they increase the availability of the latest and often most effective therapies for patients. Unfortunately, the availability of therapies under the National Health Fund in Poland is currently low. Thanks to clinical trials, a much higher proportion of patients in Poland have access to the latest generation of biologics and biosimilars based on produced human monoclonal antibodies. Given that new biological therapies can be expected to be registered in the coming years, the number of clinical trials will increase. Therefore, it is currently important to familiarise both doctors and their patients with the subject of clinical trials.
Keywords: clinical trialsrheumatoid arthritispsoriatic arthritissystemic lupus erythematosusrheumatic diseases
References
- Brodniewicz T. Badania Kliniczne. CeDeWu Sp. z o.o., Warszawa 2015: 19–27.
- Historia badań klinicznych — zarys. https://pacjentwbadaniach.abm.gov.pl/pwb/o-badaniach-klinicznych/czym-sa-badania-kliniczne/historia-badan-kliniczn/211,Historia-badan-klinicznych-zarys.html?search=41192960489071 (10.03.2023).
- Fazy badań klinicznych. https://ebadaniakliniczne.pl/pl/artykuly/fazy-badan-klinicznych (10.03.2023).
- Jeka S. 10 lat leczenia biologicznego chorób reumatycznych w Polsce. Termedia Wydawnictwa Medyczne, Poznań 2017.
- Obarska I. Nierówność w dostępie do leczenia biologicznego w chorobach autoimmunizacyjnych w Europie. Refundacja apteczna szansą na poprawę efektywności leczenia w Polsce. Polski Związek Pracodawców Przemysłu Farmaceutycznego, Warszawa 2022.