Children have the right to decide about their treatment, experts agreed at the 3rd National KH Day
Prague: The number of newly initiated clinical trials in the Czech Republic is decreasing and those focusing on the treatment of paediatric patients is even much smaller. Nevertheless, their importance for patients and doctors is enormous. The questions of how to increase the number of domestic trials and how to properly handle them in the case of minor patients were discussed by experts from all over the Czech Republic and abroad during the III National Clinical Trials Day conference, which was organised by the Senate Committee on Health and Social Policy in cooperation with CZECRIN and the PharmAround Foundation.
“We need to understand how important and beneficial the implementation of clinical trials in our facilities is for all parties. Patients and doctors have a much better chance to get earlier access to drugs or new methods, not to mention the considerable savings on pharmaceuticals, which exceed several billion crowns annually,” explained the principal investigator of the CZECRIN infrastructure, who co-organized the event, doc. MUDr. Regina Demlová, PhD. and added that most clinical trials are currently focused on the adult population and therefore clinical trials in paediatrics are a welcome topic for discussion.
Experts at the conference focused not only on specific ongoing studies, but also on general findings from their work with paediatric patients. In addition, the speakers highlighted the need for paediatric research centres to collaborate in innovating appropriate communication tools for children and researchers.
“It is important to remember that the child is not a small adult, but that he is also well aware of the situation in which he finds himself. Therefore, the most common problem we encounter is poor communication between the doctor or researcher and the young patient. The main task is to make a good assessment of the child’s social maturity and to treat him or her accordingly. Although the child’s legal guardian has the main say, it is necessary to know the attitude of the patient himself towards participation in a clinical study, regardless of his age of majority,” said one of the lecturers, the deputy head of the Children’s Clinic at the University Hospital Olomouc, doc. MUDr. Jiřina Zapletalová, PhD.
The lower number of clinical trials targeting paediatric patients may be due to stricter implementation conditions. According to JUDr. Radek Policar, Deputy Minister of Health, the preparation and conduct of clinical trials in the Czech Republic is complicated by the complex administration, which delays the implementation of studies and indirectly reduces the competitiveness of our country in this area compared to others.
However, this should soon change, thanks to an expected European Union regulation that will facilitate the entry and conduct of clinical trials without compromising their quality.
“We place great emphasis on increasing the number of clinical trials, whether they are focused on paediatric or adult patients, and therefore we expect these measures to yield results,” confirmed JUDr. Radek Policar from the Ministry of Health.
The topic of administrative and legal processes that precede the implementation of clinical trials is also dealt with by the CZECRIN organizing infrastructure, which is coordinated by the International Centre for Clinical Research at St. Anne’s University Hospital in Brno and Masaryk University.
“Contributing to the maintenance of quality and supporting academic clinical trials is a top priority for us. That is why researchers can contact us for help, whether it is clinical trials of paediatric or adult patients,” concluded Assoc. MUDr. Regina Demlová, PhD.
Photo: III National Clinical Trials Day in the Senate of the Czech Republic.
Last photo: from the left Dr. Ch. Kubiak, PharmDr. L. Součková)
Materials from the conference can be found at PharmAround website.