As of July 1 this year there were 218 clinical studies underway in Estonia, most of them as part of the process leading up to the international licensing of drugs. In most cases this means that patients are part of a larger trial group that follows tests carried out earlier of a smaller scale.
At the point where patients became part of the study, there typically are first insights available. “Clinical studies of drugs are scientific studies, and today there is no other way of proving the effectiveness and safety of drugs today,” Katrin Kiisk of the Estonian Agency of Medicines told ERR on Tuesday.
Kiisk added that all studies involving patients were preceded by laboratory tests and sometimes tests on animals, and that all clinical studies needed the approval of the agency as well as that of an ethics committee before people could be asked to participate.
The majority of studies were carried out for chronic diseases, including cancer, rheumatic conditions, but also for drugs against high blood pressure or diabetes. “This means access to new drugs, which is particularly important in cases where all other available drugs have been exhausted,” Kiisk explained.
Participants in any such study have to be informed about the risks involved, as there is always the possibility of side effects. The known ones are described to patients when they are offered participation.
The studies are typically carried out either by pharmaceutical companies or by universities. The Agency of Medicines reviews some 80 applications for studies every year, with a maximum number of 10,000 participants. The number of participants depends on the frequency of a given disease in the population.
Cancer patients profit the most
The risks involved notwithstanding, medical practitioner and member of the Riigikogu Viktor Vassiljev thinks the studies are valuable. “People invited to participate in drug studies get an additional medical check, and all kinds of procedures and analyses are done. I certainly don’t see anything bad in that, this is a perfectly normal process,” Vassiljev said.
In the North Estonian Medical Centre (PERH), which runs several hospitals, work is underway on some 100 studies. PERH’s director of medical services, Ivi Normet, explained that it was mostly cancer patients who profited from the studies.
“One very active field in our hospital are studies directed at developing cancer drugs,” Normet said. “For people suffering from tumors, this is one possibility to get state-of-the-art medication without having to pay for it.”
Editor: Dario Cavegn