Project

Implementation

WA – A [Tools] Development of new tools

WP involved

WP2: Biorepository of Basket of Baskets trial data and multi-layer visualization
WP3: Clinical Trial Management Tool Development and Optimization

Objectives

• Creation of a biorepository of data that automates the capture of clinical, molecular and imaging data (based in practical experience of BoB pilot) and allows secure, effective exploration of aggregated multi-layer data by clinical investigators (WP2)

• Creation of a user-friendly tool for the navigation and analysis of the data to facilitate the clinical-decision making (WP2)

• Development of iBANK: an application for biological sample management to track sample availability across sites and enabling the re-use of sample leftovers (WP3)

• Development of a smart electronic case report form (eCRF), based in the currently existing eCRF of the BoB study, with improved capabilities to support the collection of data generated by the CCE-DART initiatives (WP3)

• Development of iTRACKER: a web-based clinical trial management system integrating information from eCRF (clinical data), iBANK (sample tracking) and clinical decision support system currently used in CCE BoB to interpret molecular data (MTB portal) improving patient workflow and management of large clinical trials with multiple arms at different stages of development (WP3)

WA – B [CT Methods] Novel Clinical Trial Designs

WP involved

WP8: New Clinical Trial Designs: Seamless phase I/II/III trials – with adaptive decision gates

WP9: New Clinical Trial Designs: Dynamic precision medicine trials

WP10: Basket trial validation

WP11: Online Pharmacoeconomics Assessment of Innovative Treatment Approaches (Pharmacoeconomics)

Objectives

• Definition of adaptive seamless trial programmes which allow the optimization of treatment development by shortening the processes, contractual burden and decreasing the number of participants. (WP8)

• Design of clinical trial arms which incorporate novel early response endpoints based on test liquid biopsy- or novel imaging-directed treatment approaches compared with standard of care (WP9)

• Use case trial: Validation of predictive markers of immunotherapy discovered in BoB module 1 patients with ‘real world’ clinical data (patients treated with immunotherapy in CCE sites) (WP10)

• Study that assesses continuously and contemporarily effectiveness of the investigational treatment with respect to pharmacoeconomics in precision medicine, looking into companion diagnostics, molecular profiling and drug efficacy based on BoB experience (WP11)

WA – C [Biomarkers] New Cancer Biomarkers (description and objectives and WPs)

WP involved

WP4: Development of new tumor response markers – established technologies

WP5: Development of new tumor response markers – emerging technologies

WP6: Data sharing platform for the application, analysis and validation of new markers

WP7: Discovery of multi-layer complex biomarkers

Objectives

• Identification of new markers of progression/ response based on imaging and non-invasive molecular assessment methods to allow adaptive clinical trial decisions (WP4)

• Identification of new molecular and imaging markers based on emerging technologies to improve patient stratification and drug outcomes based on a cancer systems view (WP5)

• Develop the legal, technological and scientific platform to share and harness data in unified testbed (WP6)

• Integration of multi-layer data and identification of complex biomarkers outperforming the predictive value of those based on single data sources (WP7)

WA – D [Patients] Patient involvement through information and partnership

WP involved

WP12: Development of online tools for Patient Reported Outcome (PRO) measurement

WP13: A patient centered model for information and engagement in personalized medicine clinical trials: application to the Basket of Baskets trial

WP14: Promoting patient participation in innovative research

Objectives

• Organization of educational initiatives aimed at developing core researcher competencies to conduct participatory research and train investigators in the use of patient-empowerment tools developed in the CCE_DART program (WP13)

• Development of content for I Enter (WP13) and iParticipate (WP14)

• Adapt the PROACT model (a system that gathers PROs and information) to the USE CASE trial (BoB Module 1, treatment with atezolizumab of genetically-selected patients) to identify clinically meaningful reported adverse events (AEs) to investigate in following phases (WP12)

• Adaptation of an existing tool to collect AEs from the patients (PRO-CTCAE) in upcoming BoB modules (WP12)

WA – E [Dissemination] Communication, Dissemination, Valorisation, and Sustainability of the CCE-DART Model

WP involved

WP18: Communication and dissemination

WP19: Maximize the impact of the results and exploitation

WP20: Develop academic/pharma/regulatory consensus around new trial methods

Objectives

• Provision of a plan for valorization of the project addressed to the relevant stakeholders and public (WP18)

• Design of a business plan and sustainability models for CCE_DART, optimizing the implementation of the results and maximizing their exploitation and impact (WP19)

• Organization of workshops with pharmaceutical/biotechnological companies and regulatory bodies to engage them into the development of the CCE_DART (WP20)