OVERVIEW

The Biostatistics Resource (BSR) strengthens the research capabilities and furthers the scientific rigor of cancer-related research by collaborating in all phases of protocol and grant development, data analysis and interpretation, and manuscript preparation at Moores Cancer Center (MCC).

MCC members are not charged for consulting with BSR during proposal preparation and early in clinical trial protocol development. MCC funds supporting the BSR are primarily intended for research development. These activities are expected to establish long-term collaborations between MCC members and BSR personnel leading to foundation, federal and industry funding, and high-profile publications.

BSR encourages early interaction during proposal planning. For standard grant proposal development, we need four weeks' notice so we can review aims, methods and preliminary results; these do not need to be in final form. We can provide statistical sections that will include sample size, power calculations and analysis methods; and targeted biosketches and letters of support, as needed. Our program manager will supply necessary budgetary language. We recommend at least eight weeks for more complex proposals, such as program projects and SPORE awards.

Early interaction during clinical trial development is also encouraged. After obtaining an initial version of the experimental protocol, BSR will provide sample size, power calculations and justifications for any interim safety and/or efficacy analysis, and randomization plans. We will also provide data quality monitoring language. BSR does expect to be informed of any submissions to IRB, regulatory agencies and/or industrial partners. During trial operation, BSR can provide: DSMB reporting, AE reports for regulatory agencies, data analyses for required reporting to funders, in addition to any interim safety and/or efficacy analysis. BSR requires negotiated approval of trial budget prior to undertaking these activities.