Non-commercial Clinical Research in Poland

Medical Research Agency

The Medical Research Agency (MRA) is a Polish state agency, which tasks include development of scientific research in the field of medical and health sciences. Its main goal is to build an innovative healthcare system, which will contribute to a better way of meeting society’s needs through assessing which new medical technologies and therapeutic methods should be used.

Currently, the Agency implements one of the first public grant programmes that finances non-commercial clinical trials in Poland. The Agency has planned five calls for proposals for the year 2021 – two which have recently closed, concerning clinical research in rare diseases and creating and further developing Clinical Research Support Centres, and three which details are yet to be announced, concerning clinical research in psychiatry and neurology (second quarter of 2021), development of innovative therapeutic solutions that use the RNA technology (may 2021) and prevention and curing of civilisation diseases (third quarter of 2021).

Clinical Research Development Centre

The development of aforementioned Clinical Research Support Centres is one of the projects of the Clinical Research Development Centre (CRDC). The main goal of CRDC is to initiate and support the activities that aim to remove the barriers in clinical research development in Poland. From its beginnings, The Centre has been analysing and defining the scope and direction of changes to optimise the clinical research market in Poland and supporting the development of said research.

The development of non-commercial clinical research is one of the Centre’s priorities. To expand the knowledge of doctors about the possibility of conducting said research, CRDC has undertaken many activities, to raise the knowledge and competences of doctors in the filed of non-commercial research through, for example, running a website dedicated to this topic and organising seminars. The educational activity of the Centre isn’t limited to the doctors, though – they run a website meant for the patients, that holds the information on clinical research and presents it in the way to make the patients and their families feel secure in their decision to partake in such research. For the team members of research projects, as the part of the PO WER programme and the “Academy of Clinical Research – developing competence of research teams in healthcare entities providing hospital services and of doctors employed in primary healthcare facilities” project, there will be opportunities to take part in free post-graduate studies, seminars and trainings.

International Cooperation – the European Clinical Research Infrastructure Network

CEDC has also established connections with the National Institutes of Health (NIH) and the European Clinical Research Infrastructure Network (ECRIN). Thanks to the talks initiated with the ECRIN representatives, Poland has joined the network as an observer. This network is a not-for-profit organisation that supports the conduct of multinational clinical trials in Europe through, among others, helping with funding applications, regulation, ethical issues and risk assessment, as well as trial management.

Due to joining the network, The Medical Research Agency has created the POLCRIN (eng. Polish Clinical Research Infrastructure Network) unit – a Polish network consisting of centres conducting clinical research of medical products and devices.

Current Activities

As a part of the Week for the heart with MRA, the Agency is organising an informative campaign concerning the prevention of heart diseases and research dedicated to this illness. The workshops on the “Influence of the REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC” and “CAR-T cells therapy” have been recently organised. The first meeting of the General Assembly of the Polish Clinical Research Network concerning the further development of the Research Network has taken place in March. The need to educate the medical and health sciences students on the topics of conducting a clinical research has been brought up, and the possibility of using the Centres connected with the Polish Clinical Research Network for this programme was considered. The issue is to be further discussed in the next meeting.