The Biostatistics Core provides statistical expertise for the planning, conduct, analysis, and
reporting of clinical trials, epidemiologic and population based studies, studies in genetic
susceptibility of cancer, and experiments in basic research in the biology of cancer.

Director: Paul Catalano, Sc.D.
Phone: (617) 632-2441
Fax: (617) 632-2444
Email: pcata@jimmy.harvard.edu

Co-Director: Rebecca Gelman, Ph.D.
Phone: (617) 632-3629
Fax: (617) 632-2444
Email: gelman@jimmy.harvard.edu

Location of Core:

The Biostatistics Core is located across all member institutions of the DF/HCC.

Services provided by the Core include:

1. Biostatistical consulting in the planning, conduct, analysis and reporting of Clinical Trials.
   • The Biostatistics Core consults on and reviews all clinical
     protocols activated by the DF/HCC.  
   • Epidemiologic and population based studies and studies in somatic genetics
     and the risk of cancer
   • Experiments in the biology of cancer, including genomic experiments and
     laboratory and animal studies.
   • Translational research studies with combined measurements on clinical and
     biological parameters.
2. Advice and support in the preparation of grant applications of DF/HCC members
3. Scientific computing for data analysis and scientific graphics necessary for analyses of
   epidemiological, clinical, basic science, and genomic studies.
4. Advice and consultation to the Quality Assurance Office for Clinical Trials (QACT) on
   efficient and accurate database design and management of clinical research data.
5. Computer support for the clinical research database, using the Ingres system on the
   Department of Biostatistics and Computational Biology (DFCI) network.  
6. Advice and consultation to the Office for the Protection of Research Risks (OPRS) in
   the scientific and human protection reviews of clinical trials through membership on
   the DF/HCC Scientific Review Committees and the DFCI IRB, which serves as the
   central IRB for the DF/HCC.
7. Education for members of the DF/HCC in the areas of study design, data collection,
   computerization, and statistical methods for laboratory, clinical and population based
   studies.

Below are some of the Biostatistics Core Policies (approved by the DF/HCC Center Scientific
Council) that have an impact on users.

1. In general, the priorities for statistical work (from highest to lowest) are:
   • Grant preparation
   • Abstracts for national meetings, and other reports with fixed deadlines
   • Protocol design and review
   • Laboratory, animal, and epidemiology study design and review
   • Short term consults
   • Study monitoring, analysis, manuscript preparation, and replies to manuscript
     reviews
   • Education of users
2. In order to better manage statistical work on projects with external deadlines, the
   Biostatistics Core requires that the Core:
   • Be informed of new P01 and SPORE grant submissions at least 6 months before
     the deadline
   • Be informed of new R01 and K series grant submissions at least 1 month before
     the deadline
   • Be provided with data sets for an analysis for an abstract submission (e.g., for
     ASCO, AACR, ASH, ASTRO) at least 1 month before the deadline
   • Will only work on analysis and reporting for abstract presentations (e.g., for
     ASCO, AACR, ASH, ASTRO meetings) if the Core was notified at the time of
     abstract submission and the relevant statistician was given enough time to
     comment on the abstract at the time of submission.

The Biostatistics Core operates as a consultative core without a chargeback.  The justification
for operating as a consultative core includes:

• A substantial portion of the work of the core facility supports the many small early
  clinical trials in DF/HCC.  These trials often do not have a funding source that can be
  charged for statistical consulting, and the effort to obtain funding can substantially
  delay an important trial.
   
• The Biostatistics Core provides advice on the design and experimental methods for
  the initial submission of both large (SPOREs, P01s) and small (R01) grants. 
  Investigators usually do not have funding for statistical consulting during grant
  preparation work.  When statisticians assist in the preparation of large, collaborative
  grants, those applications always request separate funding for statistics as part of the
  grant budget.  When these large grants are funded, continuing statistical collaboration
  is supported directly by that grant and not by the CCSG.
   
• Biostatistical consulting is inherently an iterative enterprise, and it is not always easy
  to predict the time that will be needed to match an efficient design with other
  constraints of a study.  We believe that, within limits, the science of the DF/HCC is
  best served by producing the best possible designs and analyses without regard to
  additional constraints imposed by a charging structure for statistical consulting.

To access the core, please contact Paul Catalano at (617) 632-2441 or by email at
pcata@jimmy.harvard.edu.

http://www.dfhcc.harvard.edu/core-facilities/biostatistics/