Clinical studies are not a necessary evil nor “guinea pig" testing. Without them, advancements in medicine would not be possible; clinical studies also bring benefits to their participating patients.
Annually in Poland, nearly 500 clinical studies are performed to test new medications. Recently, the average number of participants every year has reached about 40 thousand. How do patients profit from this? According to experts, they are granted a broader access to advanced technologies, in addition to the sense of receiving better care.
Poles increasingly interested in clinical studies
“Patients who decide to participate in clinical studies receive more effective medications, whereas doctors gain the opportunity to test and implement innovative treatment methods," said Alberto Fernandez, Clinical Research Director CEE at AstraZeneca during the so-called Oxford debate at the British Embassy in Warsaw.
Without clinical studies there would be no new generation medicines used in therapies for cancer, diabetes, multiple sclerosis and many autoimmune diseases. Before being marketed, these pharmaceuticals are first administered to participants in clinical studies.
“So it’s good Poles are coming to accept these studies," says Wojciech Masełbas, Chairperson of the Association for Good Practices in Clinical Studies in Poland (Stowarzyszenie na Rzecz Dobrej Praktyki Badań Klinicznych w Polsce). In his opinion, Poles have started to act like mature societies in the West, where participation in clinical studies is commonly regarded as an alternative or supplement to standard therapies.
Safety guarantee
Polish patients are just as safe as those in the West. Prof. Piotr Fiedor, member of the Scientific Committee at the European Medicines Agency (EMA), declares their safety is guaranteed by our local regulations. That is why, in contrast to other countries, scandals surrounding medicine tests have omitted Poland.
Also the Employers’ Union of Innovative Pharmaceutical Companies INFARMA has put up a declaration on its website, stating that clinical studies “are conducted in such a manner as to comply with the strictest quality and ethical standards". They must abide by the principles of Good Clinical Practice. The underlying premise is that advantages brought about by clinical studies should outweigh potential risks.
Informed consent
Before making decision on whether to undertake a clinical study, every patient must be aware of the procedures and risks involved and organisers are obliged to provide detailed information on this issue. Patient’s consent must be in writing, with the date and signature included.
Participants in clinical studies receive medicines free of charge, and they do not pay for appointments and control diagnostic tests. The treatment of side effects is also free, should these occur during the tests. In addition, patients are insured and entitled to compensation if clinical studies result in permanent health damage.
The terms of insurance should be presented and notified to the patient before he or she signs the consent. The scope of insurance and the minimum guaranteed sums for the third-party insurance are set out in the Regulation of the Minister of Health. “Patients who participate in clinical studies should have all their rights guaranteed," stresses dr Krzysztof Mączka from the Agency for Health Technology Assessment.
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