The mCRC ARCAD Database Program

This program is an international collaboration between three of the world’s leading colorectal cancer research centers: the MAYO CLINIC, Rochester, Minnesota, USA and FONDATION ARCAD, Paris, France. The project will be led by Principal Investigators at each of these sites, and will be funded and receive organizational support from Fondation ARCAD.

The CRC ARCAD Database Project has been developed as an initiative of the ARCAD Clinical Trials Group, a global collaboration of leading cancer specialists established by Fondation ARCAD.

The primary objectives of the CRC ARCAD Database Project are (i) to construct a database pooling individual patient data from recent clinical trials in advanced colorectal cancer – the ARCAD Advanced Colorectal Cancer Database – and (ii) to use the database to clarify and help standardize the role of progression-free survival (PFS) and related endpoints in advanced colorectal cancer trials.

In addition to analyzing PFS, the project will investigate a number of further questions, including optimal endpoints for multi-line strategy trials, and the prognostic utility of biomarkers and other clinical parameters in forecasting treatment response and disease outcome. In the future, it is hoped that the ARCAD Advanced Colorectal Cancer Database will become a standing resource for the analysis of clinical trials data.

The results of the CRC ARCAD Database Project will benefit pharmaceutical development and the regulatory approvals processes for colorectal cancer drugs, leading to shorter timelines and reduced costs for clinical trials, and faster delivery of new agents to cancer patients. The model established by this research initiative is also readily translatable to other areas of oncology. Furthermore, the project provides industry with a paradigm within which it can share data with academic partners in a responsible and vetted way to achieve more efficient trials and earlier patient benefits.

Representatives from the ARCAD Clinical Trials Group met with the United States Food and Drug Administration (FDA) in May, 2009. They were advised that the FDA would welcome discussion of the group’s recommendations based on the project results, specifically with respect to regulatory approvals policy.

Extranet for ARCAD Group members only

If you want to join this initiative, please contact Mariella de Bausset, Executive Secretary of ARCAD Foundation: mdebausset@fondationarcad.org