Polish Clinical Research Network celebrates its second birthday!
On 11/03/2023. The Polish Clinical Trials Network (PSBK) celebrated its two-year anniversary. On a national scale, it is a pioneering structure that brings together public centers implementing clinical trials and is of key importance in the interdisciplinary development of the Polish biotechnology market. Currently, the Network has 23 specialized Clinical Research Support Centers (CWBKs), which have received a total of more than PLN 200 million in funding in areas necessary for the proper conduct of clinical research. The funds have been allocated for: qualified and systematically trained personnel, modern infrastructure and ICT systems that guarantee the quality, safety and correctness of the data collected.
PURPOSE AND OBJECTIVES
The establishment of a national network of clinical research centers was an initiative modeled on Western European models. Networking of centers will bring tangible benefits to all parties of the health care system i.e. hospitals, researchers and most importantly patients. The main purpose of networking the centers was to implement a common quality standard and standardize the operational processes involved in conducting commercial and non-commercial research. To this end, the Medical Research Agency(MRA) initiated meetings with representatives of experienced foreign Networks from Switzerland, Germany and Ireland, among others. In addition, ten General Assemblies were held with CWBK representatives to analyze the needs of the centers on an ongoing basis and to ensure further proper and sustainable development. In addition, to facilitate cooperation among Network members, MRA last year established 8 PSBK Working Groups in areas of key importance to center operations.
ACTIVITIES TO DATE AND PLANS FOR THE COMING YEAR
The PSBK has developed a number of tools and solutions to support the operation of Polish clinical trial centers and increase the Network's international recognition. The idea was to create a fully accessible template of the tripartite agreement to streamline and accelerate the trial contracting process. In addition to the contract template, MRA has developed: a template for a commercial and non-commercial clinical trial protocol based on a translation of the protocol from English, instructions for writing Standard Operating Procedures (SOPs) and a template SOP, a template for Patient Information, a template for the Investigator Brochure, and a template for the Informed Consent Form (ICF) for adult and minor clinical trial participants.
In addition, a task is being implemented to expand the ICT infrastructure and increase the level of digitization of the Polish Clinical Trials Network. As part of the task, it is planned to launch the MRA eCRF system, which will streamline and standardize the process of conducting non-commercial clinical trials conducted by the Beneficiaries of competitions announced by the MRA, as well as the PSBK Portal, the purpose of which will be to improve communication between Network members by creating a database of knowledge and good practices operating in clinical trials.
An important change that will take place in 2023 is to allow membership in the Network, Polish public entities that do not have CWBK in their structures, but are engaged in research activities and are involved in the development of the Polish clinical research market. This solution will add value and carry benefits for all parties to the PSBK Agreement.
Also planned for the coming year are activities aimed at increasing the competence of CWBK staff and Research Team Members, as well as continuing activities to build public awareness of clinical trials and promote PSBK on the national and international stage.
- I believe that the two years of PSBK's activities have significantly influenced the clinical trials market. We are slowly and steadily building Poland's brand in clinical trials, based on public entities. We are systematically expanding our country's potential as a research leader. We try to speak the language of benefits - Patients gain access to modern therapies, Sponsors receive reliable and credible trial data, Researchers have a chance to participate in reputable non-commercial trials funded by MRA. We are also building a number of partnerships with leaders in the clinical trials market thus raising the attractiveness of Poland as a research destination. I believe that the greatest successes are still ahead of us, because it's only been two years, and they have changed a lot in the market," noted Agnieszka Ryniec, PSBK National Coordinator and Director of the Clinical Trials Development Center at MRA .