May 2018, Prague
The number of newly started clinical trials in the Czech Republic is on the decrease and number of those that focus on a treatment of pediatric patients is even less. However, their importance to patients and doctors is enormous. The experts from all over the Czech Republic and from abroad discussed the issues of a way to increase the number of domestic studies and how to proceed correctly in the case of people under the age of 18. The 3rd National Clinical Trials Day organized by the Senate Committee on Health and Social Policy in cooperation with CZECRIN Infrastructure and PharmAround, endowment fund.
“It is necessary to realize how the implementation of clinical trials is important and beneficial for all sides. Patients and doctors have a much better chance of getting to drugs or new methods earlier, not speaking of significant savings for drugs that exceed several billion crowns a year,” explained at the beginning Regina Demlová, MD, Ph.D., the scientific guarantee of CZECRIN and co-organizer of the project and added that most clinical trials are currently focused primarily on the adult population. Therefore, the clinical trials in pediatrics are a welcome topic for discussion.
Experts focused not only on specific ongoing studies but also on general knowledge gained in collaboration with child patients. Speakers outlined the need for cooperation among pediatric research centres to innovate appropriate communication tools for children and researchers.
“We need to comprehend the fact that child is not a small adult, he is well aware of the situation. Therefore, the most common problem we encounter is poor communication between doctor or researcher and a small patient. The main task is to assess the child´s social maturity properly and act on it accordingly. Although the child´s legal representative has the lead, it is necessary to know the attitude of the patient himself to participate in a clinical study, regardless of reaching the age of 18,” said Jiřina Zapletalová, MD, Ph.D., one of the lecturers, Deputy Director of the Children´s Clinic at the Olomouc University Hospital.
A lower number of clinical trials targeted at pediatric patients may result in stricter implementing conditions. According to JUDr. Radek Policar, Deputy Minister of Health, the preparation and progress of clinical trials in the Czech Republic is complicated by an administration which delays the implementation of studies and indirectly reduces the competitiveness of our country towards others. However, this should change soon thanks to the expected European Union regulation that will facilitate the entry and realization of clinical trials without disturbing their quality. “We put great emphasis on increasing the number of clinical trials, whether targeted at children or adults, so we expect these measures will bring the results,” confirmed Radek Policar from the Ministry of Health.
It is precisely the topic of administrative and legal processes that precede the realization of clinical trials and it is dealt with CZECRIN, the organizing infrastructure. It is coordinated by the International Centre for Clinical Research at the St. Anne´s University Hospital Brno and Masaryk University. “Contribution to maintain a quality and support academic clinical trials is a top priority for us. Therefore, the researchers can ask us for help, whether it is about clinical trials of pediatric or adult patients, concluded Regina Demlová, MD, Ph.D.
Ing. Andrea Křístková, coordinator PharmAround, endowment fund, tel: +420 608 407 900
CZECRIN is the Czech network of clinical research infrastructures that connects a number of faculty hospitals, physicians and scientists in this field. It cooperates with its transnational partner, the European Network of Clinical Research Infrastructures (ECRIN). Their common goal is to work on academic clinical trials on international level. Every year, around the 20th of May, the International Day of Clinical Trials meetings and celebrations are held for both professional and non-professional public.
The PharmAround, endowment fund was founded in January 2015. It continues its activities into the successful project of the Medical Faculty of Masaryk University. Its aim is to raise awareness through the educational activities of the life-cycle issues of pharmaceuticals, in particular in relation to clinical trials, pharmacovigilance or pharmaco-economic aspects. The endowment fund organizes professional courses, workshops and conferences for doctors, educators, researchers and students.