Yale Cancer Center Biostatistics Shared Resource (BSR) Utilization Guidelines and Oversight

The BSR is a highly interactive team of cancer biostatisticians who work collaboratively with basic, clinical, translational and population science researchers to advance the frontiers of cancer medicine and public health. The Yale Cancer Center (YCC), in conjunction with the Yale Center for Analytical Sciences (YCAS), provides for the biostatistical needs of the entire YCC. YCAS biostatisticians collaborate with cancer center investigators in study design, grant/manuscript preparation and data analysis.

The best mechanism for engaging the BSR is through percent effort inclusion on grants. Absent this, there are limitations on the number of hours that can be dedicated to any individual project. The following guidelines will be used to prioritize the utilization of the BSR and to ensure fair utilization by the entire research community at YCC.

The priorities listed below will be used to triage and prioritize which studies will be eligible for BSR utilization. BSR resources are available only to members and associate members of the YCC for cancer related projects.

These priorities reflect the maximum number of hours that the biostatisticians may be able to dedicate to any particular project without compensation.

Basic Science Support

Support of basic science (with priorities TBD) will include:

• Experimental design
• Power calculations
• Development of randomization schemes
• Basic analysis (e.g.; chi-square, t-test, regression, ANOVA)
• Graph generation
• Statistical protocol development
• Office hours
• Analytic and research and design clinics (to workshop ideas)

Clinica Studies Support

The following represents the priorities identified by the YCC leadership:

• Investigator initiated clinical research trials with translational component.
• Investigator initiated clinical trials.
• Prospective IRB-approved translational trials in a protocol setting.
• Cooperative group multi-center trials.
• Industry sponsored trials.

Retrospective studies (laboratory based or otherwise) with clinical correlations

Population Science Support

The following represents the level of biostatistical support for population science:

• Study design, including sample size/power calculations and analytic plan
• Development of randomization schemes
• Analysis
• Grant and manuscript preparation

Efforts will be made to ensure parity of access for both basic, clinical, translational and population science projects. Nonetheless, limits on staffing may dictate that the scale of large jobs be capped. The size of such a cap will be determined by the BSR Oversight committee and is likely to change over time based on usage and staffing.
Currently, the guidelines for resources provided by YCC gratis will be as below. Additional resource hours will require funding by the investigator or by special approval by the BSR Committee through a special application. All investigators are entitled to receive a minimum of 16 hours per year. Limits are as below

• Grant preparation for NIH funding – as many hours as reasonably required to prepare the grant. More than 40 hours requires committee approval.
• Unfunded analyses, including those for manuscript preparation – 16 hours total per investigator per year.
• Investigator-initiated trials–16 hours for study design; as many hours as reasonably required (to be reviewed by the Oversight Committee) to monitor, analyze and publish the study.
• IRB approved translational projects – 8 hours for design and 16 hours of analysis per project
• Grant preparation for internal (e.g., TTARE) and external (non-NIH) funding – 8 hours.
• Analyses and manuscript preparation for peer-reviewed and funded grants- 8 hours (or percent effort) are per grant budget.

Hours beyond the above utilization limits may be provided under two mechanisms:

• Waiver: Additional hours may be obtained by a waiver from the Oversight Committee
• Fee-per-hour: Usage beyond the free limit may be charged on a fee-per-hour basis

In addition to the support outlined above, support for data management for basic, clinical, translational and population science will be available through the BSR on a fee for service basis.

Standards for academic credit vary among research disciplines. For small-scale routine consultations, BSR does not expect authorship.

Reasonable expectations for larger projects must be guided by a sense of fairness and proportionality and community standards. The International Committee of Medical Journal Editors provides consensus guidelines on publication credit that can be used as a framework for publication credit discussions. It is recommended that users of the resource have a direct discussion of these issues in the context of job specification discussions in early phases of the project so that a consensus can be achieved.

A committee headed by the Associate Cancer Center Director for Clinical Sciences will be constituted to help judge the suitability of projects and to monitor the amount of time spent as well as receive requests for additional utilization of the BSR.

The utilization review committee will meet on an as needed basis and at least quarterly to review utilization. The committee will consist of the following:

• David Stern, MD, Director of Shared Resources
• Howard Hochster, MD, Associate Cancer Center Director for Clinical Sciences;

Affiliated YCAS Faculty and Staff:

• Peter Peduzzi, PhD, Director of YCAS peter.peduzzi@yale.edu