Medical Research Agency celebrates second birthday
The Medical Research Agency is celebrating its bicentennial. This period coincides with International Clinical Trials Day on May 20. This is a special time when we focus on popularizing issues related to clinical trials, providing reliable information on them and supporting this area.
Since its inception, the Medical Research Agency has supported the development of non-commercial clinical trials in the country. In 2020, it contracted nearly one billion PLN for this purpose, which translated directly into registering almost three times more non-commercial clinical trials than in previous years. In addition, these funds will give tens of thousands of patients access to new investigational therapies.
Support for civilization diseases
The first competition for non-commercial clinical trials, launched in 2019, highlighted a long-standing gap in tapping this market and its potential. The huge interest in the competition and the fact that the allocated budget of PLN 100 million was almost fifteen times exceeded, showed how much this activity was needed. Under the first competition, 32 clinical trials were co-financed for a total amount of over PLN 543 million. In 2020, as many as three rounds of competition were announced, thanks to which 34 projects received support. The total amount for this purpose exceeded PLN 370 million. The vast majority of projects submitted in the competitions concerned oncology/hematology and cardiology, i. e. the most common civilization diseases.
In recent years, the incidence and mortality associated with lifestyle diseases have improved slightly. Unfortunately, this situation has been exacerbated by the ongoing COVID-19 pandemic. Due to this huge demand, the Medical Research Agency will announce the third edition of the competition in the third quarter of the year with a budget for another 100 million PLN. The goal of the competition is to increase accessibility for patients or people threatened by civilization diseases to innovative diagnostic and therapeutic solutions in this area, as well as to improve care for patients with civilization diseases resulting from raising competence of the medical environment and broadening knowledge in this field.
The creation of the Polish Clinical Research Network, which brings together beneficiaries forming Clinical Research Support Centres, is also a particularly important programme in terms of increasing competence, staff development and biotechnological infrastructure in our country. Thanks to PLN 100 million provided for this purpose, Polish facilities engaged in clinical research received support for development and retrofitting. In 2021, five more centres will join the Network. This is not only an important initiative allowing the expansion of the national biotechnology infrastructure, but most importantly access to research conducted at the highest level.
Programmes for forgotten areas
An important program supported by ABM is the development of CAR-T technology, dedicated to patients undergoing hemato-oncology treatment. Currently, a large Polish consortium led by the Medical University of Warsaw is preparing this technology for implementation in our country. The funds obtained under the PLN 100 million grant from ABM will allow Polish laboratories to equip themselves so that within a few years they will be able to offer Polish technology many times cheaper and more widely available.
Responding to more health needs, in early 2021 the Medical Research Agency also announced a competition for non-commercial clinical trials in rare diseases and trials in neurological and psychiatric diseases - an area that has been underexplored for many years. A special role in the process of the decision to co-finance these areas was played by the voices of the environment, alarming about the urgent need for support for these directions.
Patients' Voice
Since its inception, the Medical Research Agency has listened to the demands of patient organisations, the medical community as well as academia. To meet the needs of patients and their interests, the President of the Medical Research Agency has established a special working group on patient needs.
The established group will have an advisory function within the ABM activity areas. In addition, it will focus its activities on articulating the most pressing needs of the community and building patient awareness about participation in clinical trials.
Law on Clinical Trials
One of the extremely important activities carried out by the Medical Research Agency is the development of a draft law on clinical trials of medicinal products for human use, prepared by a drafting team appointed by the Minister of Health. The draft Bill has now gone to public consultation.
It is an extremely important document which allows to adjust the Polish law to EU regulations, but most importantly to put in order the clinical trials market in our country, to make it attractive to non-commercial and commercial entities, as well as safer and more accessible to patients. The adoption of the Act will be a milestone in increasing Poland's competitiveness as a location for clinical research.