Building Data Rich Clinical Trials

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.