On 21 June 2024, the State Expert Center of the MoH of Ukraine held for the first time a working meeting of experts of the Department of Expert Evaluation of Preclinical and Clinical Trial Materials (hereinafter – the Department) and experts of the Center’s consultative expert groups “Advanced Therapy Medicinal Products (ATMP)” and “Medicinal Toxicology”, with the participation of the Sector for Coordination of the Work of Consultative Expert Groups, to discuss the results of the expert evaluation of materials of a clinical trial (hereinafter – CT) whose object of study is an advanced therapy medicinal product, namely a medicinal product for gene therapy.
As a reminder, on 26 January 2024, MoH order No. 138 approved and put into effect amendments to the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Clinical Trial Materials, approved by MoH of Ukraine order of 23.09.2009 No. 690, which establish requirements for conducting clinical trials of advanced therapy medicinal products in Ukraine.
The subject of discussion at the aforementioned meeting, aimed at finding a consolidated decision on the results of the expert evaluation, was the materials of the clinical trial (CT) “Phase 1 Study ADI-001 of Anti-CD20 CAR-Engineered Allogeneic Gamma-Delta (γδ) T Cells in Adults with Lupus Nephritis” concerning all aspects of the CT protocol, the investigator's brochure, the investigational medicinal product dossier, and other materials for investigators and study subjects.
Effective communication among specialized expert evaluation experts helps improve the quality of professional assessment of clinical trial materials, achieve a consistent scientific opinion, and produce correct, well-grounded expert conclusions.
Such meetings are introduced by the department as needed for all clinical trials (CTs) of advanced therapy medicinal products and for other CTs concerning, in particular, complex CT design, the use of decentralized elements in conducting CTs, etc.
