In an interview with PAP, Sierpinski talks about the fact that the Agency has already granted PLN 50 million for coronavirus-related projects, including projects for developing new technologies in the field of medicines and tests. He announces a competition for research using CART-cell technology and adding a clinical trials search engine for patients to the www.pacjentwbadanich.abm.gov.pl website, so that patients can search for relevant trials by entering basic data on the disease.

PAP: We celebrate the International Clinical Trials' Day on May 20th. What is your assessment of their current situation in Poland? How did the establishment of the agency affect it?

Radosław Sierpiński: Undoubtedly, the establishment of the Medical Research Agency, which is also celebrating its anniversary, has significantly changed the clinical trials market in Poland. Activities undertaken by the agency to date support the research sector on many levels.

On the one hand, we have already spent about half a billion zlotys on non-commercial clinical trials, thus supporting 28 projects in this field, which was more than the number registered in the Office for Registration of Medicinal Products in all previous years. We are talking about a several hundred percent increase in this market sector, which is extremely important especially from the perspective of patients who will gain access to modern therapies and innovative treatments. This will definitely be the first noticeable change.

On the other hand, we conduct extensive teaching and educational activities when it comes to clinical trials. Through the 'patient in trials' website, we show how valuable clinical trials are for patients. I think that patients finally have a source of objective knowledge that will allow them to make fully informed decisions related to participation in a trial, and thus contribute to increasing recruitment for trials.

The third extremely important aspect is the impact of clinical trials on the economy. Poland is currently becoming an attractive market for investment in clinical research for an increasing number of biotechnology companies and large pharmaceutical companies. I am convinced that in the long run this will translate into increased revenues for the state budget.

PAP: What projects is the agency currently financing, what are its plans?

R.S.: The most important area of activity according to the Law on the Medical Research Agency is supporting non-commercial clinical trials. I have to admit that the success of the first competition, where the allocation exceeded the originally assumed grant several times, showed how great the demand is. The projects selected by the agency are high-quality research that meets immense social needs. I am talking about research in the field of oncology or paediatric haematology.

We are in the process of preparing to announce a competition for research using CART-cell technology, much anticipated by patients. This is extremely ground-breaking technology, but also an extremely expensive one. It is currently unavailable in Poland, or available to a limited extent. We want this innovative therapy to be available to Polish patients, to be a domestic technology. I think that the next months will be associated with the commencement of work in this area.

PAP: The agency will allocate 100 million to Clinical Trials Support Centres. What exactly will they be responsible for, where will they be established?

R.S.: We have launched a competition for Clinical Trials Support Centres, an infrastructure project that is expected to change the clinical trial ecosystem in Poland. We want specialized centres to be created in clinical hospitals and research institutes. On the one hand, they will give patients great comfort, and on the other hand they will allow us to develop a very high standard of research.

Academic hospitals, consortia of universities and clinical hospitals, as well as research institutes have the greatest potential in this area. These are the units that have an excellent staff of professors, a huge volume of patients, and often treat very difficult cases. The competition is also addressed to such centres as, for example, Regional Cancer Centres, units that form the National Cancer Network, where cancer patients often seek help. We suspect that these units will have great potential for these trials and, importantly, they will be profitable units within hospital structures.

PAP: In addition to planned competitions, the agency quickly responded to the coronavirus problem and allocated support to projects in this area. Which 'COVID' projects have received a positive recommendation: quick tests, imaging tests, anything else?

R.S.: By dynamically allocating PLN 50 million, we have probably been the fastest to respond to the needs for developing new technologies in the field of coronavirus drugs and tests. I am glad that this competition attracted great interest, the MRA received nearly 100 applications. We already know that this allocation will be increased because some applications have very high potential. As part of the launched fund, the Medical Research Agency will co-finance approximately 20 projects in the field of vaccine development, therapy and the development of rapid diagnostic testing methods.

We see particular potential in the field of drug technologies, including a very promising therapy using the healed patients' plasma in the treatment of patients, or antiretroviral drug tests that can cause the disease to be milder. I think it will be a clear Polish contribution to controlling the pandemic worldwide.

On the other hand, thanks to the provided support, very promising research can be carried out in Poland to develop innovative rapid tests that will increase the number of tested patients. According to the Minister of Health, we will struggle with this pandemic for a long period, so the proposed solutions will accompany us and I hope that in the next six months we will have first results of the projects we have started.

PAP: In recent months, coronavirus has changed our reality. Did it also affect the supervision of ongoing research?

R.S.: Not yet from the agency's point of view. Of course, there were recommendations from both the European Medicines Agency and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products regarding clinical trials. Some trials have been suspended or halted, some reduced recruitment - this is obvious. From the agency's perspective, it is business as usual, we are launching planned trials, signing contracts, spending funds. I think this process will not be disrupted.

PAP: You mentioned the educational activities of the agency. What is the status of the www.pacjentwbadanich.abm.gov.pl website, how popular is it?

R.S.: Patient in clinical trials (www.pacjentwbadanich.abm.gov.pl) is an extremely important initiative that gives patients access objective knowledge about clinical trials. I am glad that we are co-creating this website with key organizations from the science sector, public administration, patient foundations and the pharmaceutical industry, thanks to which the website is constantly updated with new knowledge.

We plan to add a clinical trials search engine for patients, so that they can search for relevant trials by entering basic data on their disease. Combined with the knowledge the website provides, we not only build patients' awareness of safety and informed participation in trials, we also want to facilitate their access to trials. I think that the project will be implemented next year, when the MRA budget have sufficient funds that will allow us to develop this tool.

PAP: The Medical Research Agency is celebrating its first anniversary. What are the current top challenges for the agency for the coming years?

R.S.: The Medical Research Agency is a mature institution, implementing its statutory provisions. Our involvement in the fight against coronavirus has shown the efficiency of the institution, for which I would like to thank my employees.

When it comes to challenges for the coming years, for the first time in history we have the chance to respond to global biotechnology trends. The budget of the Medical Research Agency will reach PLN 1 billion by 2028. We certainly want to monitor global trends and, as in the case of the CART-cell project, ensure that the technologies that were previously available to Polish patients only abroad are permanently available in Poland. I am convinced that innovative, Nobel-level research can be done in Poland. (PAP)

Author: Katarzyna Lechowicz-Dyl

ktl/ mhr/ kap/

tr. RL