About the Network
The Polish Clinical Trials Network (PCTN) was set up on 11 March 2021 through an agreement between the Medical Research Agency and the Beneficiaries of the 1st edition call for proposals for the establishment and development of Clinical Trials Support Centres. It aims at implementing uniform, systemic solutions for quality and process management at institutions involved in conducting clinical trials in Poland.
The common standards and clinical trial information management models in place within the Network are intended to make the Polish clinical trial market more attractive to sponsors, and particularly encourage them to use public sector institutions as venues for their research. Continuous implementation of new solutions is expected to have a direct impact on reinforcing Poland’s position in the clinical trial industry, boosting the competitive advantage of domestic infrastructure and its potential to support high quality research in order to promote more effective international cooperation. The PCTN is intended to ensure effective country-wide recruitment, streamline the feasibility process, as well as support the training of dedicated clinical trial staff. Consolidating the procedures for clinical trial performance, pricing and billing, as well as accelerating the contracting process, will contribute in the long term to optimising the costs of drug reimbursement and drug policies within the healthcare system. This will directly benefit Polish patients, who will be granted access to breakthrough innovative treatments with higher efficacy and better safety profiles.
The role of the Medical Research Agency – the Clinical Trials Development Centre
The Clinical Trials Development Centre (CRDC), established at the Medical Research Agency in order to initiate and support measures to overcome the barriers in clinical trial development in Poland, and hence to tap into our country’s full potential and stimulate further advancement of research, is the key institution responsible for the functional performance and efficiency of the PCTN, as well as for setting the operational standards of the Network and its constituent Clinical Trials Support Centres (CTSCs). The CRDC provides solutions and tools necessary to facilitate clinical trials at the CTSCs, in order to guarantee patient safety and comfort and ensure top quality of the research projects carried out at these facilities.
CRDC also engages in educational activities aimed at enhancing the competence and qualifications of CTSC study teams; for more on this topic, go to the Educational initiatives tab.
PCTN’s organisational structure
The Network Council is responsible for providing opinions on the 3-year development strategy of the Polish Clinical Trials Network, endorsing the Network’s yearly business plans and approving uniform system and process quality solutions associated with clinical trial performance across the Network. The Network Council is composed of representatives of the Ministry of Health, Centrum e-Zdrowia, the National Health Fund, the Agency for Health Technology Assessment and Tariff System and three members of the General Assembly. The Council is chaired by the National Coordinator of the PCTN.
The Business Council is an advisory body for the Network Council in the area of identifying the prospects of clinical research and building an environment that favours growth in this sector. The Business Council recruits its members from among representatives of the pharmaceutical industry, members of the Polish Association of Clinical Research Organizations (POLCRO), representatives of the Employers' Union of Innovative Pharmaceutical Companies INFARMA, as well as members of other associations, foundations, and patient organisations. Members of the Business Council are appointed by the President of the Medical Research Agency.
Meetings of the General Assembly are attended by representatives of the Medical Research Agency and the individual Centres of the Network. The General Assembly is responsible for conceptualising the Network’s development strategy and the principles of multi-institutional collaboration between parties to the Agreement, as well as for supporting the Medical Research Agency in its educational efforts.