Enhancement of conduct-effectiveness in investigator-initiated clinical trials by implementing a comprehensive risk-based quality management approach

• Applicant: Professorin Viktoriia Dobrova, Ph.D.
• Subject Area: Public Health, Healthcare Research, Social and Occupational Medicine
• Term: since 2023
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 518476314

The main project aim is to investigate issues, barriers, and gaps for intensification of investigator-initiated clinical trials implementation in Germany and the EU as well as to create an effective methodology of risk-oriented trial management for them. The project will focus on translational clinical trials with respect to oncology, cell therapy, and vaccine design research. The objectives of the project are: 1) to define potential gaps, barriers, and risks for investigator-initiated clinical trials through analysis of current EU regulations for clinical trials operation, and by reviewing the scientific literature on quality management approaches in clinical research, with the focus on the investigator-initiated clinical trials; 2) to investigate practical issues, stakeholder’s opinions on the prerequisites and matters for the implementation of a quality management system and the concept of risk management for investigator-initiated clinical trials in the field of oncological, cells therapy, and vaccine design research, and carry out statistical modeling for quality risk assessment of investigator-initiated clinical trials; 3) to develop a framework, recommendations, and tools based on a risk quality management approach for enhancement of investigator-initiated clinical trials, and initiate the indicators metrics for assessment of their effectiveness.

• DFG Programme: WBP Position