MDICT Task Force

Background
The MDICT Task Force is an international task force sponsored by the NDDO Education Foundation, chaired by Elizabeth Eisenhauer, NCIC Clinical Trials Group, and Giuseppe Giaccone, U.S. National Cancer Institute, Medical Oncology Branch. Its members are leading phase I and II investigators and its mission is to develop practical guidance on the optimal development of innovative anticancer agents, in particular targeted agents. Methodological guidance developed by MDICT should improve the efficiency of the future development of oncology drugs, in particular in the early clinical phase. Output generated by MDICT should be applicable to groups of drugs belonging to a certain class (e.g., targeted agents with a similar mode of action). Organizational aspects of early-phase clinical development of anticancer agents may be addressed to secure a smooth flow of the most interesting agents through the clinical development pipeline worldwide.

Observers from industry and regulatory agencies will be invited to MDICT meetings to give feedback on guidance developed by MDICT. Methodological output generated by MDICT is made publicly available through publication in peer-reviewed journals. Meetings take place in conjunction with annual TAT meetings.

MDICT output
Thus far, three MDICT meetings have taken place, in conjunction with TAT 2006, 2007 and 2008, addressing issues in phase I and phase II studies of oncology drugs, and the potential roles of phase 0 studies in anticancer drug development, respectively. Reports of the MDICT meetings held in 2006, 2007 and 2008 have been published in the European Journal of Cancer:

1. Booth CM, Calvert AH, Giaccone G, Lobbezoo MW, Seymour LK, Eisenhauer EA. Endpoints and other considerations in phase I studies of targeted anticancer therapy: Recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies (MDICT). Eur J Cancer 2008 Jan;44(1):19-24.

2. Booth CM, Calvert AH, Giaccone G, Lobbezoo MW, Eisenhauer EA, Seymour LK. Design and conduct of phase II studies of targeted anticancer therapy: Recommendations from the task force on Methodology for the Development of Innovative Cancer Therapies (MDICT). Eur J Cancer 2008 Jan;44(1):25-29.

3. Kummar S, Doroshow JH, Tomaszewski JE, Calvert AH, Lobbezoo M, Giaccone G. Phase 0 clinical trials: Recommendations from the task force on methodology for the development of innovative cancer therapies. Eur J Cancer (2008), doi:10.1016/j.ejca.2008.10.024.