Project description
From clinical trials to data-rich translational research programmes
Strategies for cancer treatment are evolving from surgery, chemotherapy and radiotherapy towards targeted therapy. Precision oncology is the future of fighting cancer. In efforts to test new technological and methodological concepts, Cancer Core Europe developed the Basket of Basket study to provide personalised treatment to a larger number of patients by incorporating a molecular profiling platform, flexible modules targeting different molecular alterations and a data/sample collection plan to enable translational research. The EU-funded CCE_DART project will improve efficiencies and transform platform trials into data-rich translational research programmes. It will develop digital tools for trial management; integrate imaging and molecular markers of tumour progression and drug response; develop a new clinical trial methodology; and increase patient engagement.
Objective
Successful drug approvals on Precision Oncology (PO) using basket studies have uncovered new challenges. Research in small patient populations suffers from sustainability/ logistical issues. Platform trials are flexible solutions to test different drugs in different populations but encompass management issues that compromise flow and translational research. This is detrimental to patients/ researchers thus new technological/ methodological concepts must be urgently implemented. To overcome these limitations, Cancer Core Europe (CCE) has developed the Basket of Basket (BoB) study to provide personalized treatment to a larger number of patients by incorporating a multi-tiered molecular profiling platform, flexible modules targeting different molecular alterations and a data/ sample collection plan to enable translational research. The CCE-DART model, here proposed, is conceived to address other limitations of PO and platform trials identified by our multi-disciplinary team. With a new design, we aim to improve efficiencies and transform platform trials in data-rich translational research programs, by: (1) developing digital systems (information-technology solutions) facilitating data management and clinical-decision-making; (2) integrating accurate, dynamic imaging and molecular markers of tumor progression/ drug response; (3) using more efficient, adaptive clinical trial methodology; (4) increasing patient engagement. To achieve this, we will use harmonized data-sharing/ technological/ legal/ clinical infrastructure developed in CCE and the BoB trial that will be leveraged as a use case for testing the new model. The new concept will impact the design of new clinical trials consolidating a self-sustainable, data-rich, multi-endpoint global platform for clinical/ translational research, encompassed by a pharmacoeconomics assessment that will proof the sustainability of the model for its implementation in the Health System and as a return of the investment to society.
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RIA - Research and Innovation actionCoordinator
08035 Barcelona
Spain