Frontier Science Foundation - Hellas (FSF-H)

Frontier Science Foundation - Hellas (FSF-H) is a not-for-profit corporation founded in Athens in September 2007. It is the newest affiliate of the Frontier Science & Technology Research Foundation (FSTRF) network.

Frontier Science is a not-for-profit research foundation established in 1975 to advance the application of statistical science and practice and data management techniques in science, health care, and education. The Foundation is incorporated in the State of New York and has offices in Amherst, New York, Boston, Massachusetts and Madison, Wisconsin. There are currently approximately 350 staff members employed by Frontier Science (www.fstrf.org). The President, Marvin Zelen, Ph.D., is an internationally renowned biostatistician and former Chair of the Department of Biostatistics in both the Harvard School of Public Health and the Dana-Farber Cancer Institute.

FSF-H supports research through the design, conduct, analysis and reporting of clinical trials in all major disease areas and especially cancer and AIDS. FSF-H launches studies in important public health areas, such as syndromic surveillance. FSF-H is strongly committed to the education and training of physicians/health professionals on issues of clinical research.

The mission of FSF-H is to offer cutting-edge science and clinical trial operations safeguarding Good Clinical Practice principles.

FSF-H is dedicated to the advancement of Clinical Research in Greece.

• FSF-H offers cutting-edge science and unparalleled clinical trial operations. These include:
• Protocol development,
• Statistical design,
• CRF design,
• Trial monitoring,
• Regulatory approvals,
• Database design,
• Data management,
• Quality control,
• Statistical analysis
• FSF-H organizes specialized educational Seminars and Workshops for Healthcare professionals

• Marvin Zelen, PhD, Chairman of the Board, Prof. of Statistical Science, Harvard School of Public Health
• Constantine Gatsonis, PhD, Professor of Medical Science (Biostatistics), Director of the Center for Statistical Sciences, Brown University, Acting Head of the Biostatistics Section, Dept of Community Health
• Richard Gelber, PhD, Professor, Department of Pediatrics, Harvard Medical School and Professor, Department of Biostatistics, Harvard School of Public Health and Department of Biostatistical Science, Dana-Farber Cancer Institute, Boston
• Urania Dafni, ScD, FSF-H Director, Professor of Biostatistics and Director of the Laboratory of Biostatistics, Faculty of Nursing, School of Health Sciences, University of Athens
• Dimitris Karlis, PhD, Assistant Professor in Statistics, Athens University of Economics & Business

• TEAM trial (Greek component)
• TEAM trial (International component)
• ARBI trial
• ATENA trial
• COPA trial

1. The HERA trial is a non-US, Phase III, randomised, multicentre, open-label trial comparing adjuvant Herceptin^TM (ROCHE) for one or two years versus observation, in 5100 HER2-positive breast cancer women. This is a pivotal trial that changed the treatment for HER2-positive breast cancer globally.
• The statistical analysis for the 4-year update of the HERA trial for one -year adjuvant Herceptin^TM (ROCHE) vs observation has been completed by FSF-H and the manuscript submitted to NEJM.
2. The TRANSHERA network runs multicentre, translational research projects relative to the HERA trial. One of the current projects is also funded by NIH.
• FSF-H is responsible for the design and statistical analysis of the TRANSHERA network projects.