The competition to establish and develop Clinical Research Support Centers continues until the end of September. There are already 23 such institutions across Poland, and thanks to funds from the RRF, there will be even more. The Agency expects an increased quantity and quality of clinical trials, as well as their accessibility for Polish patients. As part of the RRF, support will also be available to enhance and increase the research potential of the existing CRSCs.
“The clinical research sector has seen a rapid growth in recent years, due in part to funds allocated by the Medical Research Agency for non-commercial clinical trials,” says Dr. Karolina Nowak, the Director of Department of Innovation and Biotechnology Development at the Medical Research Agency, to the Newseria Biznes news agency.
As indicated by the MRA, before its establishment, the number of registered non-commercial clinical trials in Poland remained at the level of a dozen or so projects. Over the past five years, this number has tripled. Thanks to MRA funding, nearly 280 projects have been completed, with a total value of over 3.5 billion PLN. The launched studies have provided more than 60 thousand patients with access to clinical trials at over 900 institutions across the country.
“We are evolving not only in terms of quantity but also in terms of the quality of our studies, the quality of understanding by patients what medical trials are, why they are necessary for the healthcare system, and how patients can participate in the results and benefits related to clinical trials. This also presents the opportunity to benefit from innovative therapies that are very expensive through participating in clinical trials,” says Dr. Karolina Nowak.
The dynamic development of the clinical research market has led to the establishment of specialized units implementing such projects. In March 2021, the Medical Research Agency signed an agreement with the beneficiaries of the first competition for the creation and development of specialized Clinical Research Support Centers. The aim was to utilize the potential of Polish public centers conducting clinical research, create conducive conditions for initiating non-commercial clinical trials, and increase access to innovative pharmaceutical technologies for Polish patients. Within three years, 23 Clinical Research Support Centers have been established in Warsaw (6), Lodz and Wroclaw (3 each), Poznan, Walbrzych, Opole, Katowice, Gdansk, Lublin, Gliwice, Bialystok, Szczecin, Gdynia, and Kielce.
In mid-July, the MRA announced a competition for the establishment and development of Clinical Research Support Centers, funded with EU resources as part of the National Recovery and Resilience Plan. 150 million PLN has been allocated for this purpose, and applications will be accepted until 30th September 2024. Eligible applicants include public universities teaching medicine, public universities conducting educational and research activities in the field of medical sciences and health sciences, research institutes, scientific institutions, and medical entities.
“Through the support of Clinical Research Support Centers, we can expect an increase in the number of clinical trials, as well as an improvement in their quality and accessibility for Polish patients,” says Dr. Karolina Nowak, the Director of the Department of Innovation and Biotechnology Development at the Medical Research Agency. “In addition to infrastructure support, the existing Clinical Research Support Centers have received additional funding for IT infrastructure, which will serve to digitize and network all the facilities. This will enable data collection and exchange, which is currently a hot topic at the European and global level.”
The competition for the development of CRSCs is one of several competitions that the agency has announced or will announce as part of the RRF funds. One of these, announced on 19th July, is a competition for entrepreneurs in the pharmaceutical field, providing for the co-funding of innovative projects, such as new pharmaceutical forms like biosimilar drugs. The MRA has allocated 350 million PLN to this competition, while the funding amount for one project ranges from 2 to 12 million PLN, with up to three projects per company to be submitted. The application period runs until September 19th. The minimum duration of a project cannot be less than 12 months, and the maximum cannot exceed 18 months. The end date for project completion cannot be later than March 31st, 2026. However, it will take much longer before innovative pharmaceuticals finally appear in pharmacies.
“The first results will be apparent through scientific development: deepening knowledge, experience, but we will still have to wait at least 7-10 years for the first product results, as the development of medicinal products is a very lengthy process. The biomedical field is also very heterogeneous, as the development of a new medicinal product is different from the development of a new medical device. Therefore, the wait for medicinal products will be longer than for new medical devices, which we as an agency also support as part of RRF funds.” points out Dr. Karolina Nowak. “Poland only has experience with innovative drugs on three medicinal products, so we do not have the necessary skills and knowledge on how to properly and quickly introduce medicinal products to the market. Hence, the instruments we have developed for R&D work will contribute to new products that we will see in pharmacies in the future.”
