ABM/2022/1

The Medical Research Agency is launching a call for non-commercial clinical trials (ABM/2022/1).

The main objective of the call is the development of new diagnostic and therapeutic methods in different fields of medicine.

Additional points are awarded for projects on oncological diseases or childhood diseases (including infant, newborn and prenatal stages) or age-related diseases (i.e. above 60 years of age) or infectious diseases and their complications, including additionally the post-covid syndrome (so-called long-COVID), and immunological diseases.

Projects submitted in the Call must have the status of a non-commercial clinical trial regarding the evaluation of the effects of a medicinal product. The trial must be designed so as it evaluates the influence of a medicinal product on the human organism.

The Rules and Regulations provide for the financing of non-commercial clinical trials which focus on the development of new diagnostic methods if they are developed under the clinical trial of a medicinal product.

Essential changes with respect to the previous editions:

The following requirements were introduced in the Call:

1. to bank biological material - whereas, the Agency provides financing of the storage of a material sample in the biobank in the course of the Project, and the Beneficiary is obliged to cover the costs of storing the sample for 3 subsequent years after the Project is completed;

and

2. to attach to the Application a draft of the clinical trial protocol.

Deadlines for submitting the applications in the system:

• Round 1: from 17 January 2022 to 17 March 2022; the Project must start not earlier than on 1 June 2022, but not later than on 1 August 2022;
• Round 2: from 17 March 2022 to 17 May 2022; the Project must start not earlier than on 1 August 2022, but not later than on 1 October 2022.

The maximum duration of the Project is 6 years (72 months).

NOTE:          

1. Persons interested in the preparation and submission of the application (regardless of whether MUW shall be the Leader or Consortium Member in the Project) are kindly asked to send by e-mail a scan of completed and signed  Project Notice  to the address of the Project Support Department awn@wum.edu.pl within 30 January 2022.

2. The internal deadline for submission of complete applications at MUW for Round 1 expires on 10 March 2022. 

3. Pursuant to the decision of the University Governance, all applications shall require:

1. a written approval (e.g. e-mail) of the Head of the Hospital Department/Entity for conducting of the project in the Department,
2. a written approval (e.g. e-mail) of the Hospital Director for project implementation in the hospital base.

Applications without the required approvals will not be examined.

4. The Projects must fulfil the condition of being registrable in the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) as non-commercial clinical trial of a medicinal product, which means that the trial design and the very manner of its being conducted must meet any standards that regulate conducting clinical trials, i.e. Pharmaceutical Law and implementing acts, along with the GCP/GMP principles.
5. The possibility of submitting applications by a Consortium set up for the purpose of implementing the Project is allowed. The number of Consortium members – max. 4 entities. Signed Consortium Agreement shall be a mandatory appendix to the application in the ICT System.

6. The Consortium Members are selected under an open call conducted prior to submitting an application based on the announcement, with at least 14 days’ deadline for the Consortium Members to apply.

An applicant planning the project implementation under a Consortium, should take into consideration the time necessary for conducting the procedure of selecting the Consortium Member(s) prior to the preparation and submission of the Application.

7. The Consortium Members may be entities (e.g. university or research institute) which jointly implement the Project in terms of its substance, i.e. participate in the preparation of the design of the Clinical Trial, including in particular the participation in: preparation of the Application  objectives, design of the Clinical Trial protocol, process of Trial registration, analysis of data being the result of the Clinical Trial, incurring the costs related to the Project Implementation, in joint pursuit to achieve the Project goal.
8. MUW Teaching Hospitals and other research centres shall appear in the Project as Subcontractors. A centre is understood as a medical entity which participates solely in the clinical part foreseen by the clinical trial protocol.
9. There is no maximum value of the project. For each of the two rounds an allocation of PLN 100 m is foreseen.

Applications must be submitted in electronic form only via the ICT system available on the Agency’s website: https://konkurs.abm.gov.pl/#/

Details regarding the call can be found on the ABM website:

https://abm.gov.pl/pl/aktualnosci/1236,Agencja-Badan-Medycznych-oglasza-Konkurs-na-niekomercyjne-badania-kliniczne-ABM2.html

We particularly encourage you to read appendices 4 as well as 5a, 5b and 5c regarding the project evaluation criteria (Appendix 5c).

Should you have any questions, please contact the Project Support Department awn@wum.edu.pl