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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.

Clinical Trials Support Centres (CTSC)

The idea behind creating dedicated Clinical Trials Support Centres was to harness the potential of Polish public facilities engaged in clinical trials, create a favourable environment for investigators to initiate non-commercial clinical trials (thus increasing the overall number of clinical trials conducted in Poland), and offer Polish patients better access to innovative technologies. The Signatories to the Agreement – and hence members of the Polish Clinical Trials Network – are 23 Clinical Trials Support Centres.

In 2020 and 2021, the Agency announced two editions of the call for proposals for establishing and developing Clinical Trials Support Centres (CTSCs) and one call for specialised oncology and hemato-oncology CTSCs (OncoCTSCs). The principal areas of funding are:
🔸Hiring highly qualified stuff, 
🔸Adaptation/modernisation of infrastructure,
🔸Purchase of quality and support systems,
🔸Staff training. 

As part of the first edition of the call (ABM/2020/3), the Agency earmarked approx. PLN 100 million to subsidise ten specialised facilities across the country. These were:
🔸Medical University of Gdansk
🔸Children’s Memorial Health Institute in Warsaw
🔸National Geriatrics, Rheumatology and Rehabilitation Institute, name of prof. Eleonora Reicher in Warsaw
🔸Cardinal Stefan Wyszynski Institute of Cardiology in Warsaw
🔸National Oncology Institute of Maria Sklodowska-Curie – National Research Institute (branch in Gliwice)
🔸Poznan University of Medical Sciences
🔸Wroclaw Medical University
🔸Medical University of Bialystok
🔸Medical University of Lodz
🔸Military Medical Institute in Warsaw

In the second edition of the call (ABM/2021/4), funding in the total amount of approx. PLN 50 million was granted to six institutions: 
🔸4th Military Clinical Hospital in Wroclaw
🔸Central Clinical Hospital of the Ministry of Interior and Administration in Warsaw
🔸Pomeranian Medical University in Szczecin
🔸Medical University of Silesia in Katowice
🔸Medical University of Lublin
🔸University of Opole

In support of the third edition of the call (ABM/2021/6), dedicated to oncology and hemato-oncology CTSCs (OncoCTSCs), the Agency provided approx. PLN 45 million to seven facilities:
🔸Lower Silesian Oncology Center in Wroclaw
🔸Polish Mother's Memorial Hospital – Research Institute in Lodz
🔸Institute of Hematology and Transfusion Medicine in Warsaw
🔸Dr Alfred Sokolowski Specialist Hospital in Walbrzych
🔸Pomeranian Hospitals LLC
🔸Holy Cross Cancer Centre in Kielce
🔸Voivodeship Multi-Specialist Center for Oncology and Traumatology in Lodz

From among the 23 Beneficiaries of the calls for proposal for Clinical Trials Support Centres, 9 institutions have received funds for early phase clinical research.


CTSC Model Standard


The CTSC Model Standard is intended for Applicants and Beneficiaries of competitions for the establishment and development of CTSCs announced by the Medical Research Agency and for entities wishing to become members of the Polish Clinical Trials Network (PCTN). Applicants and Beneficiaries are primarily required to comply with detailed legal regulations, ICH GCP and the Declaration of Helsinki. These guidelines address minimum requirements, with the Applicant and Beneficiary required to provide resources appropriate to the level of complexity, risk and characteristics of the research appropriate to its operations.
CTSCs are required to implement uniform systemic quality and process solutions to standardize the conduct of clinical trials. The purpose of the document is to indicate the minimum requirements, optimal criteria and guidelines for the use of funds in the implementation of projects for the establishment and development of MRA-funded CTSC..

In 2023 the standard was updated to version 2.0 and adapted to the changes that have taken place in recent years in the Polish market due to the COVID-19 pandemic and the economic situation.

Joint to the Polish Clinical Trials Network

Depending on the nature of your business or experience, you can join the Polish Clinical Trials Network (PCTN) as an Observer, Member or Partner.

Find out more by going to the MRA website.