Cancer Core Europe’s investigator-initiated clinical trials will benefit from expedited contracting and the ability to quickly open trials across all member centers.
The harmonized procedures put in place will facilitate Cancer Core Europe’s interactions with pharmaceutical industry partners. Our expertise in clinical biostatistics and methodology will support innovative next-generation clinical trial design.
- Profile patients according to molecular signatures and pathway alterations.
- Assess whether matching treatments to molecular abnormalities induces antitumor activity.
- Evaluate tumor heterogeneity, sensitivity, and resistance to therapy.
- Launch joint clinical trials.
- Follow-up patients using biopsies and liquid biopsies.
- Use innovative statistical designs in clinical trials with expert biostatistical support from within Cancer Core Europe.
- Facilitate communication with pharmaceutical companies.
Plans for the coming years
The recently initiated CCE-DART project is a H2020-funded project that aims to deliver novel methods for the design and implementation of novel, more robust and effective clinical trials in oncology by exploiting the mass data generated throughout these studies.
The Basket of Baskets (BoB) trial is currently open and recruiting patients with one active module, and a second soon to be initiated. We will ensure the continuity of the study by activating additional modules. Patients participating in this trial are discussed weekly in a multidisciplinary Molecular Tumor Board,
through the MTB Portal, an ad hoc online clinical decision support tool.
We will activate three specific working groups (WGs) to bring together clinical and translational researchers: Immunotherapy, Precision Medicine, and Early Drug Development. These WGs will identify key scientific questions which will constitute the main focus of our research. Our aim is to work on innovative proposals to accelerate cutting-edge discovery and translate our findings to the clinic.
To deliver on the promise of personalized medicine, the task force will work together with the Genomics task force to establish a Molecular Prescreening Strategy. In the short term, we will agree on a common set of genes and obtaining the pertinent ISO certifications. In the longer term we will work together to set up a common platform across the 7 centers. In parallel, we will also perform a “Pharma Top Tour” to consider the needs of industry as well as foster the exchange of ideas and collaboration with CCE.
Our specific objectives over the coming years are as follows:
- Activate 2-3 new modules in the BoB clinical trial.
- Initiate an additional trial outside BoB.
- Obtain competitive funding based on the proposals presented by the WGs.
- Ensure fluent communication with pharma companies.
Connection to main theme virtual data center
The two main themes of CCE must be tightly connected to ensure an efficient implementation of the proposed CCE projects.
Through the CCE-DART project we will be able to align the strategy of both main themes regarding to the harnessing and exchange of data. By working alongside the Genomics task force we will be able to establish a common platform that will need to be aligned with the Virtual Data Center strategy.