Non-commercial clinical trials account for only 2% of clinical trials conducted in Poland. The recently established Agencja Badan Medycznych (ABM) wants to change this. It has just announced the first competition with a pool of PLN 100m.
ABM counts on 40-50 projects worth financing
The competition is open to projects from the areas of pediatrics, neonatology, neurology, haematology, radiotherapy, cardiology and oncology. According to Krzysztof Gorski, Director for Implementation of ABM Scientific Projects, quoted by Rynek Zdrowia, the talks with researchers in the largest centres in Poland show that a lot of research on paediatric oncology in the field of rare diseases can be submitted to the competition. In total, the Agency counts on receiving 40-50 projects worth co-financing.
According to the competition rules, the duration of the project should not exceed 6 years. 100% of eligible costs related to a non-commercial clinical trial will be financed, provided that the final report from the trial is published in the ABM ICT system.
Formal and substantive criteria will be taken into account when evaluating the project. The latter will concern, among others, the scientific value of the project, the impact on the improvement of citizens’ health, innovativeness and expected economic effects. Points will also be awarded for the possibility of applying the project results in the health care system.
Experience will be a rewarding criterion
Only medicinal entities or applicants with the consent of the medicinal entity to conduct a non-commercial clinical trial involving patients shall be eligible to enter the competition. At the same time, such entities must have proven experience in the treatment of patients with the condition for which funding is requested. Experience of the entity in conducting at least three clinical trials (commercial or non-commercial) between 2016-2019 in a similar therapeutic area (or a similar patient population) is also required.
Additional points can be obtained by centres which have in their structure a specialised unit for conducting scientific research, as well as by those projects in which a foreign partner with experience in clinical trials will participate. The awarding criterion is also the implementation of at least one non-commercial clinical trial (between 2014 and 2019) by the applicant or a therapeutic entity. The implementation here means successful recruitment of patients for the study. Additional points will also be awarded to sponsors of non-commercial clinical trials (within the last 5 years), as well as to those projects that assume a later production of a product in Poland.
Applications may be submitted in Polish and English. The deadline for their submission is 29 November. Later, within 2 weeks, the formal assessment is to be ready, and after 3 months – the substantive assessment.
Non-commercial clinical trial is a clinical trial in which the data generated in the course of the trial are owned by a sponsor, which is a university or federation of entities in the higher education system and science, a researcher, a patient organisation, a research organisation, a research organisation or any other natural or legal person or entity without legal personality. The purpose of such an entity shall not be to profit from the conduct and organisation of clinical trials or the manufacture or marketing of medicinal products. Data obtained in the course of a non-commercial clinical trial may not be used for the purpose of obtaining a marketing authorisation for a medicinal product, making changes to an existing authorisation or for marketing purposes.