Department of Biostatistics and Computational Biology
David P. Harrington, PhD, Chair
The Department of Biostatistics and Computational Biology conducts basic research in statistical and computational methods for clinical trials, population-based studies, and cancer biology. The department also participates extensively in interdisciplinary research in each of these areas with teams of investigators, providing expert consultation on the experimental design and analysis of clinical, laboratory, and population-based studies. Faculty and staff statisticians in the department play central roles in the development of all clinical research protocols at Dana-Farber/Harvard Cancer Center (DF/HCC) and serve as members of the Scientific Review Committees and the Institutional Review Boards.
The new name of the department (changed from Biostatistical Science) reflects our expanded activity in computational biology and bioinformatics during the last three years. Members of the department have built widely used software systems for computational biology, including DNA-Chip Analyzer, or dChip (Cheng Li, PhD), and BioConductor (Robert Gentleman, PhD), and have made contributions to understanding the genetic basis of cancer. In 2005, John Quackenbush, PhD, moved from The Institute for Genomic Research to DFCI, where he will continue his biological research into the genomics of cancer and other diseases and will extend his software systems, including TM4 and the Gene Index Data Base.
During 2004, department members authored or coauthored more than 100 peer-reviewed publications. These articles appeared in a range of journals in cancer research, biostatistics, and bioinformatics, including the Journal of Clinical Oncology, Journal of the American Medical Association, Blood, Journal of the American Statistical Association, Cancer, Biometrics, and Bioinformatics.
Statisticians in the department prepare or review the statistical designs and analysis plans for all clinical protocols conducted at DFCI and DF/HCC through membership in the disease programs, the DF/HCC Scientific Review Committees, and the Institutional Review Board. Along with statisticians, bioinformaticians, and epidemiologists at other Harvard schools and teaching hospitals, members of the department direct core statistical resources for the Cancer Center Support Grant, six Specialized Programs of Research Excellence (SPORE) grants, and many program project grants. In addition to clinical studies, this collaborative research includes work in population-based studies through the DFCI Center for Population-Based Research and studies in the biology of cancer through the Center for Cancer Systems Biology and the Center for Cancer Genome Discovery.
Several of the department's collaborative projects extend beyond DFCI. The department serves as the Statistical Center for the Eastern Cooperative Oncology Group (ECOG), the International Breast Cancer Study Group (IBCSG), the Cancer Care Outcomes Research and Surveillance Consortium (CanCORS), and the Lunenburg Lymphoma Biomarker Consortium (LLBC). ECOG is a consortium of over 350 hospitals and smaller treatment centers in the United States funded by the National Cancer Institute (NCI) to conduct multicenter clinical trials in adult malignancies. Now more than 50 years old, ECOG maintains a database of more than 100,000 cancer cases, and is conducting active follow-up of over 20,000 patients treated in clinical trials. Recent ECOG studies have shown that the addition of the anti-VEGF monoclonal antibody bevacizumab to standard chemotherapy improves outcomes in patients with advanced colon, lung, or breast cancers. Other major studies have shown the benefits of rituximab therapy for non-Hodgkin's lymphoma and of thalidomide therapy for multiple myeloma. ECOG is also initiating new studies investigating the use of molecular markers to tailor treatments for patients with breast and colorectal cancer. The ECOG Statistical Center is led by Robert Gray, PhD.
IBCSG is a network of institutions in Europe, South America, Australia and New Zealand, Asia, and South Africa. Since 1978, IBCSG has conducted large, randomized phase III clinical trials evaluating the timing and duration of chemotherapy and the role of endocrine therapy as adjuvant treatment for breast cancer. IBCSG has been a leader in the field of tailored treatment approaches for specific subpopulations of patients with breast cancer. Members of this department, led by Richard Gelber, PhD, comprise the Statistical Center for the IBCSG. An internationally recognized expert in the field, Dr. Gelber co-organized the ninth St. Gallen (Switzerland) International Conference on Primary Therapy of Early Breast Cancer, held in January 2005, and coauthored the annual proceedings.
IBCSG is conducting trials of tailored treatment approaches in two somewhat rare subpopulations: older patients with endocrine-nonresponsive early breast cancer who are not candidates for standard chemotherapy regimens (the CASA trial, launched in 2005); and younger patients with endocrineresponsive early breast cancer (the SOFT, TEXT, and PERCHE, or STP, trials, launched in 2003). The STP trials are the first studies that IBCSG has undertaken in collaboration with North America; as of October 2005, nearly 1,000 patients had been enrolled and randomized at almost 200 centers worldwide. Recently, a combined IBCSG-Breast International Group study was stopped early because postmenopausal patients with endocrine-responsive breast cancer who were treated with adjuvant letrozole showed a statistically significant improvement in disease-free survival compared with those treated with tamoxifen. Study results recently appeared in the New England Journal of Medicine.
The Statistical Coordinating Center of CanCORS is headed by David Harrington, PhD. CanCORS is a population-based study of diagnosis, treatment, and outcome in lung and colorectal cancer, with special emphasis on the reasons behind well-documented disparities in treatment by race or ethnicity and age. In December 2005, the study team completed its interviews of more than 10,000 patients or their caregivers, and will conduct a complete review of these patients' medical records during 2006.
Edie Weller, PhD, is the lead statistician in the international LLBC effort to standardize the measurement of biomarkers for diffuse large B cell lymphoma and to validate their prognostic relevance using data from large clinical trials performed by cooperative groups throughout the world. The analysis of more than 800 patients in six different countries (Canada, England, France, Germany, The Netherlands, and the United States) will include clinical data and specimens; results are expected to be available in December 2006.
In addition to its research, department continues its close partnership with the Department of Biostatistics at Harvard School of Public Health, where the majority of our faculty hold primary academic appointments, teach in the degree programs, and direct doctoral students. During the past two years, our faculty have chaired major academic committees, such as the Curriculum, Degree Program, and Doctoral Qualifying Examination committees, and also have become involved with undergraduate teaching in the Harvard University Faculty of Arts and Sciences.
