Scientific and Technical Capabilities
The objectives of the Biostatistics Shared Resource (BSR) are as follows:
- To ensure excellent and timely biostatistical support in the design and protocol development of laboratory, translational, clinical, and population-based anti-cancer research studies;
- To provide appropriate state-of-the-art statistical analysis, interpretation, and reporting of anti-cancer research studies;
- To support UACC clinical trials by serving on the Scientific Review Committee, the UACC Data and Safety Monitoring Board, and the Cancer Prevention Phase I/II Consortium Data and Safety Monitoring Board.
One of the key functions of the BSR is to provide biostatistical collaboration and consultation to The University of Arizona Cancer Center (UACC) investigators. The personnel of the BSR are active in all phases of study design, conduct, data management, statistical analysis, and manuscript preparation. Services offered are: protocol development; review of Cancer Center protocols; data analysis and reporting; statistical database applications; data services and computer programming; education and training; and statistical consultation and collaboration.
Proportional usage of the BSR across the UACC programs did not change markedly in 2013. The total number of hours of usage increased 15% from 2012.
Personnel in the BSR have wide-ranging involvement across the research activities of the UACC, including clinical, translational, basic, and population research. Biostatistical collaboration and consultation have been provided for investigators in each of the four scientific programs in the UA Cancer Center. Collaboration of Biometry personnel with Cancer Center investigators on the design, conduct, analysis, and interpretation of cancer studies continues to enhance the quality of the research.
BSR personnel are often asked to serve as co-investigators on individual investigator-initiated grants. Biostatistics faculty have also had success in receiving funding for Biostatistics (and related) Cores in a number of long-term research projects. Such projects grow out of BSR activities initially supported by the CCSG. Such projects currently active include:
- Chemoprevention of Skin Cancer Program Project (P01CA27502; P.I., David Alberts): Basic science and early phase prevention studies designed to develop oral and topical compounds for reversal of precancerous skin lesions.
- SPORE in Gastrointestinal Cancer (P50CA95060; P.I., P. Thompson-Carino): The long-term objective is to prevent and cure GI cancers. The overall translational goal is to develop novel and more effective approaches to prevention and treatment.
UACC biostatisticians serve as co-investigators on numerous other funded grants. Examples include:
- Phase I/II Cancer Prevention Consortium (N01CN35158; P.I., H.-H. (Sherry) Chow)
- Evaluation of Diindolylmethane Supplementation to Modulate Tamoxifen Efficacy in Breast Cancer Survivors (R01CA149417-01A1; P.I., Cynthia Thomson)
- Selenium Colorectal Cancer Chemoprevention Trials (R01CA151708-01A1; Co-P.I.s. Peter Lance/ Patricia Thompson-Carino)
- NSAID Effects on Clinical and Imaging Breast Biomarkers (1R01CA1615301A1; Co-P.I.s Alison Stopeck/Patricia Thompson-Carino).
- Metformin for Reduction of Obesity-Associated Breast Cancer Risk (1R01CA172444-01A1; P.I., H.-H. (Sherry) Chow)
Additionally, UACC biostatisticians collaborate in the development of new R01 and SPORE grant applications. During the past twelve months, UACC biostatisticians have been heavily involved in the successful submission of a new SPORE application in GI Cancer. Additional R01, PPG and industrial grant applications include:
- The Role of FXR in Colorectal Tumorigenesis PPG (Joint P.I.s Patricia Thompson-Carino and Jeffrey Smith)
- Study of Biomarkers in Ovarian Cancer: Modulation by Activity and Diet Intervention (P.I. Cyndi Thomson)
- Amgen Pharmaceutical: Phase II Study of Denosumab in Patients at Increased Risk of Breast Cancer Recurrence (Joint P.I.s Patricia Thompson-Carino/Alison Stopeck)
Assistance also is provided to more junior investigators in the preparation of R03, R21 and K07 applications.
Biostatistics faculty members also play a key role in assisting clinical investigators in developing early phase investigator-initiated clinical trials. This includes reviewing the draft protocol and developing the statistical considerations and sample size justification. When needed, it also involves assistance in addressing statistical concerns of potential pharmaceutical sponsors and CTEP (Cancer Therapy Evaluation Program, NCI).