Medical Research Agency

An opportunity to summarize and present plans of the Medical Research Agency for the next year was a conference entitled "Scientific priorities in health for 2022. The role of the Medical Research Agency in creating an innovative health care system". The event was opened by the Minister of Health Adam Niedzielski - I am very pleased that the model of the Agency's development is a model of creating not only a grant-giving institution, but also a competence center, a center of knowledge about the directions of development and the challenges we face - said the Minister. He expressed hope that the year 2022 will be a continuation of the current development of the Agency and clinical research in Poland.

As Minister Niedzielski added: "Thinking that the healthcare sector will develop without new technologies, without innovation, is thinking out of the realm of reality. If we look at our priorities in the coming years, we can see that we will have an increasing demand for medical services, which results, among others, from the aging of society (...) and supply is limited, because we have few specialists in the system. Only technology can allow demand and supply to meet.

Change in the clinical trials market

The year 2021 will be a record year in terms of the number of registered and ongoing clinical trials in Poland. - It will be over 800 clinical trials. Non-commercial research alone will be around 100, so we are talking about a gigantic increase since the Agency was established - emphasized the President of the Medical Research Agency, Radosław Sierpiński, MD.

Since its inception, the Medical Research Agency has allocated a total of over PLN 1.5 billion to support the execution of clinical trials. - These are over 130 projects in the field of oncology, cardiology, geriatrics or pediatrics. Of course the amount is impressive but the most important is that 50 thousand patients will benefit from access to innovative therapies - added President Sierpiński.

ABM is also investing in changes at the level of clinical trials market infrastructure, creating a Network of Clinical Trials Support Centers providing comprehensive and systemic support in the execution of both commercial and non-commercial trials. Soon, the 16 centers within the network will be joined by another Oncology Clinical Trials Support Centers, which will support development of medical innovation in Poland and increase in the number of clinical trials.

Scientific plans for 2022

The coming year will be an intensive time of development for the Medical Research Agency. It is a time of investment in new, long-awaited projects in the field of medical devices. It is also a time to support non-commercial clinical trials in areas raised in discussions with the patient and scientific communities. These activities will be implemented in support of the National Health Programme 2021-2025.

Among the priority areas for next year, there are also call for clinical research in medical devices with artificial intelligence, robotics and telemedicine, as well as a call for research in public health epidemiology.

Medical devices with AI, robotics and telemedicine

Activities planned by the Medical Research Agency in 2022 include grants dedicated to the development of medical devices, including artificial intelligence and telemedicine. These calls fall under one of the Agency's priority funding areas at a total level of over PLN 500 million.

- The value of the Polish medical device market in 2018 reached about €2.5 billion, which represented an increase of as much as 40 percent compared to 2017. - informed during the conference Dr. Piotr Iwanowski, Clinical Development Advisor at start-up company Oasis Diagnostics SA, which conducts research on new technologies in the medical sector.

As Arkadiusz Grądkowski - President of the All-Poland Chamber of Commerce of Medical Devices POLMED - stressed, "The market for medical devices is very receptive and innovative. In 2018, 18,000 patents relating to medical devices were registered in the European Union alone. For comparison - there were several thousand fewer medicines registered in Europe at that time. In Poland, there are currently about 16 thousand registered medicines, while medical devices - as many as ca. There are currently around 16,000 registered medicines in Poland, while the number of medical devices is around 300,000.

On the one hand, we are talking about the fact that the entry threshold for the manufacture of medical devices is low, so there are a lot of such devices, but whether they will achieve market success and be a systemically accepted solution depends on many factors. The remedy for a kind of fragmentation of the medical device market is an attempt to create solutions that would enable long-term data collection and their systemic use - emphasised Mirosław Kwaśniewski, PhD - Head of the Centre for Bioinformatics and Data Analysis at the Medical University of Białystok.

Epidemiological studies

In the third quarter of 2022, the Agency for Medical Research plans to implement a call dedicated to non-commercial epidemiological research with an allocation of 100 million PLN. Among other things, the goal of the call is to provide up-to-date epidemiological data in areas identified as priorities within the Epidemiological Research Development Strategy developed by ABM

The last two years have changed the perception and development of epidemiological research.  The emergence of the COVID-19 pandemic has again placed infectious disease epidemiology in a position of priority over other branches of the discipline.

As pointed out by Grzegorz Juszczyk, MD, PhD - Director of the National Institute of Public Health - National Institute of Hygiene, in the coming year we will observe two cumulative phenomena. The first of them will most probably be the continuation of the fight against the COVID-19 pandemic, and the second - growing health problems that may result from restrictions in access to services due to the ongoing pandemic.

However, modern epidemiology is not limited to infectious diseases and epidemic assessment. The same principles can be applied to the assessment of chronic diseases such as cardiovascular disease, cancer, diabetes, as well as mental health or addiction.

- In the longer term, we can expect a large number of chronic diseases, not only cancer, but also cardiovascular disease. This is due to the fact that we are living longer, which in turn generates more health problems. Therefore, the system should be focused on the protection of the elderly - emphasized Joanna Didkowska, MD, PhD - Head of the Department of Epidemiology and Primary Prevention of Cancer, Head of the National Cancer Registry at the Central Informatics Centre raising the issue of health challenges waiting in the coming years.

Head-to-head studies - a need or a stick in an anthill?

A particularly active discussion during the conference concerned the implementation of a call for head-to-head tests. The main goal of the call is to provide the public payer, the medical community and patients with information on the most clinically and cost-effective therapy or diagnosis.

As Krzysztof Kopeć, President of the Polish Association of Employers in the Pharmaceutical Industry, emphasized: "In head-to-head studies, we should not talk about comparing the original drug versus the generic, but about comparing therapies and types of interventions that can give the most benefit in terms of better cost-effectiveness. (...) The challenge for us in head to head studies should be how to shape the effectiveness of the therapy to achieve the best possible outcome.  

- The discussion about generic drugs, or biosimilars, or biosimilars is more or less closed. We know that these are substances with similar effects, considering them as interchangeable drugs. (...). However, when it comes to head to head studies, the arena on which comparative research can develop is vast. Directions worth defining in terms of conducting head to head studies could be indicated by the Ministry of Health. This would allow to show in which specific areas these call could take place. - emphasized Prof. Marcin Czech - President of the Polish Pharmacoeconomic Society.

Responding to key health priorities

Medical Research Agency tries to address current challenges in the health care system. As the President of the Medical Research Agency emphasized in closing this year's conference - Our global goal and ABM priority is, above all, that the number of patients participating in clinical trials financed by the Agency increases every year. This is the most important thing we do - bringing new technology to patients, enabling them to live longer, better lives - and this is the most important goal we have. 

Indicating the priority area of ABM's activities for the next year, President Sierpiński pointed out the call dedicated to medical devices using artificial intelligence, as he emphasised - the potential of Polish biotechnology is located largely in medical devices. The amendment to the ABM Act, which allows us to take up this subject, due to the possibility of financing medical experiments is a very good way to go. We want to support researchers and innovative companies, show that Poles also can and we can implement new technologies. I hope that we will be able to finance the best projects in this area.