Cancer Biostatistics

The mission of the Cancer Biostatistics Shared Resource (BSR) is to provide statistical support to HICCC investigators from the study design stage of a project through to its execution, analysis and interpretation, and finally, to the dissemination of the work. The objectives of this resource are:

• To collaborate with HICCC investigators in the design, conduct, analysis, interpretation and reporting of their clinical, laboratory and population science studies.
• To collaborate with HICCC investigators in their research initiatives and grant proposals.
• To collaborate with HICCC investigators on scientific publications.
• To advise the HICCC Protocol Review and Monitoring Committee by providing statistical review of the design of studies and their conduct.
• To provide short-term statistical consulting to HICCC members.

To conduct methodological research which will lead to improved methods for study design and data analysis in cancer research.

Guideline of Timeframe Requests

Please contact the Cancer Biostatistics Shared Resource as early as possible before your deadline and be aware of the following guidelines:

• Abstracts: We generally need at least four weeks to perform data analysis for abstract submission.
• Grants: We typically need at least a month of active collaboration with investigators for new single-project grant submissions. Multi-project grants, such as SPOREs and program-project grants, require considerably more time (four months, at least), given the amount of coordination required.
• Manuscript Preparation: The Cancer Biostatistics Shared Resource requires a minimum of four weeks from the time an appropriately formatted data set has been submitted to carry out analyses and summarize results and methods for inclusion in manuscripts.
• Protocol Preparation: The Cancer Biostatistics Shared Resource requires a minimum of three weeks to prepare the statistical considerations (including study design and analysis plans).
• Other Consultations: We will help you with consultation on other tasks as appropriate. Again, the more lead-time we have, the better we can assist you.

On a case-by-case basis, the Cancer Biostatistics Shared Resource may decline requests that arrive too close to the deadline for us to provide anything useful. Please also consider that more complex designs or analyses will require more time.

User Policies and Fees

The Cancer Biostatistics Shared Resource includes doctoral- and masters-level statisticians who provide short-term consultation on specific projects, and long-term collaboration on studies. In some cases, support for certain categories of projects will be provided by specific consultants.

Policies

Having an understanding the Cancer Biostatistics Policies outlined below will help the consultants deliver timely and effective support services to investigators:

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 consultation
• Study monitoring, analysis, manuscript preparation, and replies to manuscript reviews
• Education of users

2. In order to better manage work-flow on projects with external deadlines, the Cancer Biostatistics Shared Resource requires that the Director and consultants:

• Be informed of new program project grant application submissions (e.g. P01, SPORE) at least 6 months before the deadline
• Be informed of new R01 and K series grant application submissions at least 1 month before the deadline
• Be provided with data sets for an analysis prior to 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 Director/consultant was notified at the time of abstract submission and the assigned statistician was given enough time to comment on the abstract at the time of submission.

User Fees

The Cancer Biostatistics Shared Resource operates as a consultative service without a chargeback. This is the case for several reasons:

• A substantial portion of the work of the statisticians supports clinical trials which may not have a funding source that can be charged for statistical consulting.
• The Cancer Biostatistics SR provides advice on the design and experimental methods for the initial submission of program 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.
• 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 HICCC is best served by producing the best possible designs and analyses without regard to additional constraints imposed by a charging structure for statistical consulting.

For more information, please visit the Department of Biostatistics at the Mailman School of Public Health.