Building Data Rich Clinical Trials (CCE-DART)

PI: Elena Garralda

CCE_DART aims to incorporate newer and more effective methods to the design, conduct, and analysis of academic clinical trials. The project has been built around Cancer Core Europe (CCE), a network of comprehensive cancer research centers, and the Basket of Baskets (BoB) Clinical Trial, a modular multi-country investigator-led precision medicine trial. 

Objectives 

• Developing cutting-edge digital tools designed to streamline trial management and support clinical decision-making processes. 
• Utilizing state-of-the-art clinical trial methodologies, integrating novel statistical designs to optimize efficiency and accuracy. 
• Incorporating precise and dynamic imaging techniques alongside molecular markers to provide a comprehensive understanding of tumor drug response, thereby enhancing trial design and implementation. 
• Empowering and actively involving patients throughout the research journey, ensuring their perspectives and needs are central to the investigative process. 

One of the Project innovations was the creation of a dedicated development area, led by the s.s. Biostatistics for Clinical Research and  the s.c Cure Palliative-Hospice-Terapia del Dolore e Riabilitazione at the Fondazione IRCCS Istituto dei Tumori (INT), specifically focused on patients. 

This initiative emphasised both the importance of providing patients with general information about clinical trials and their active involvement in the design and implementation of studies. Regarding patient information, a public-facing website with explanatory texts and videos (iENTER) was developed, along with two web apps: iCONSENT, which supports the informed consent process and manages electronic signatures; and iPARTICIPATE, which facilitates document exchange and messaging with oncologists, as well as the scheduling of patient appointments. 

Moreover, INT  developed a training course particularly dedicated to clinicians and health researchers, to provide the fundamentals of Patients and Public Involvement (PPI) together with the tools to conduct PPI-based research in the best possible way.