20.05.2019 change 20.05.2019

Experts: Increase in applications for clinical trials of drugs in Poland in 2019

Photo: Fotolia Photo: Fotolia

In the first months of 2019, the number of applications concerning the commencement of clinical trials in Poland increased by 40 percent, according to information presented at a press conference in Warsaw on the occasion of the International Clinical Trials Day on May 20.

President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Grzegorz Cessak admitted that in recent years the number of clinical trials reported in Poland had been stagnant. The data he presented showed that in the years 2011-2018, 400 to 450 such trials were registered annually.

But now the situation should change. "In the first half of 2019, the number of submitted applications for clinical trials increased by 40% compared to 2018" - Cessak said. In the past year, nearly 400 clinical trials were registered in Poland. Simplification of the European Union registration procedure of clinical trials has contributed to this year`s growth, he admitted.

According to the data presented by Cessak, the largest number of clinical trials conducted so far in Poland concerned the third, so-called pre-registration phase. This phase accounted for half of these trials. 30 percent clinical trials in Poland were second phase trials, and first phase - only a few percent.

"The remaining trials concern the fourth phase, in which the effects of drugs are tested on a large group of patients after the drug has been registered and introduced into treatment" - Cessak added.

He explained that in the first phase of clinical trials, the safety of using the newly developed drug is checked. The second phase involves testing the safety and efficacy of the drug and possible adverse effects depending on the dose used. In the third phase, the effectiveness and possible side effects are assessed.

"During the whole period of the individual phases of the clinical trial, strong emphasis is placed on the safety and efficacy of the tested drug" - emphasised Teresa Brodniewicz, president of the Association for Good Practice of Clinical Trials in Poland.

She added that all clinical trials are preceded by experiments on various species of animals designed to preliminarily test the drug. "The safety profile of the tested drug is very important, without it no bioethics commission will permit human trials" - the expert assured.

"But we must remember that clinical trials always involve a risk, because there is no drug that causes zero adverse reactions" - explained Prof. Wiesław Jędrzejczak, former national haematology consultant. "If a drug does not cause side effects, it means that it does not work" - he added.

In Poland, there are still many reservations with regard to clinical trials. This is indicated by the online survey cited during the meeting with journalists: "Clinical trials through the eyes of Poles", conducted in 2018 on a group of 1836 people (average age 38).

It shows that 40 percent respondents believe that pharmaceutical companies bribe physicians who conduct clinical trials in order to launch new drugs. 39 percent believe that doctors do not inform patients about all aspects of the trial, and 27 percent suspect that doctors and nurses withhold important information that could influence the decision on further participation in the trial.

35 percent respondents believe that patients participating in clinical trials are treated as "guinea pigs" by doctors and pharmaceutical companies.

Experts emphasized during the press conference that patients may discontinue participation in a clinical trial at any time. They also pointed out that for many patients, especially those with advanced cancers, clinical trials of a new drug were a chance for a new, more effective therapy.

President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products said that Poland was in seventh place in the European Union in terms of the number of clinical trials, behind Germany, the UK, Spain, Italy, Belgium and the Netherlands. In his opinion, which was also confirmed by experts, it would be possible to carry out twice as many clinical trials in Poland.

PAP - Science in Poland, Zbigniew Wojtasiński

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