About Biostatistics

The HDFCCC Biostatistics Core is a shared resource providing statistical expertise and collaboration to Cancer Center investigators on all phases of basic science, translational, clinical, epidemiological, and prevention research.

Mission

The mission of the Core is to ensure rigorous and efficient planning, conduct, and reporting of research using best practices in biostatistics, and to advance research methodologies via education and innovation.

Core Members:

Mi-Ok Kim, PhD, Director
Joan F. Hilton, ScD, MPH
Jimmy Hwang, PhD
Ann Lazar, PhD, MS
Iryna Lobach, PhD
Annette Molinaro, PhD
Alan Paciorek, BS
Li Zhang, PhD

Key Services

We support development and review of protocols, grant applications, and other collaborations by providing statistical expertise in the following areas:

Study Design

Providing assistance with overall design considerations including formulation of research questions and hypotheses, selection of appropriate sampling scheme and endpoints, sample size and power computation, statistical analysis planning, and randomization. Expertise on adaptive trial design is also provided.

Study Conduct

Providing assistance with randomization, questionnaire design, variable definition, database structure, interim analysis, resolution of statistical questions as they arise during ongoing studies, and data safety monitoring (through participation in the Data Monitoring Committee).

Data Analysis and Study Results Reporting

Conducting or supervising data analyses, and assisting with interpretation and reporting study results.

Teaching 

Offering formal courses through the Department of Epidemiology and Biostatistics and informal lectures via individual presentations. Topics covered in the informal lectures include:

  • Statistical issues in the design/conduct of clinical trials
  • Sample size determination
  • Interim analyses
  • Multiple hypothesis testing
  • The role of regression adjustment in analysis of data from clinical trials

Collaborative Process

All projects are subject to a triage/prioritization procedure. Details of the procedure are provided below under the Core’s policy on Priorities and Utilization Limits. In order to best serve HDFCCC members and their research, and to properly allocate resources, we strongly encourage investigators to contact us as early in the planning or analysis process as possible. We recommend minimum two weeks in advance for brief consultations, two month for any consultation requiring a significant time investment including grant development. Please submit your collaboration request here.
 

SUBMIT A REQUEST

We schedule initial consultation meetings to assess the scope of work and nature of the requested collaboration. After the triage/prioritization process, Core members are assigned to the project based on required area of expertise and level of expertise, disease site committee affiliation, and availability. This may mean that the statistician who initially consults on a project may not ultimately end up being the statistician for that project. All decisions concerning the allocation of the Biostatistics Core resources and project assignments are made by the Director on a case by case basis.
 

Priorities and Utilization Limits

It has always been the goal of the UCSF HDFCCC Biostatistics Core to give cancer researchers as much assistance as possible, particularly new and/or junior researchers who may not have well established funding sources. Specifically, we give priorities to HDFCCC members over non-members and prioritize projects in the following order:
 
  1. 1. Funded peer-reviewed studies, peer-reviewed grant applications, investigator-initiated protocols based on discoveries at UCSF
  2. 2. Investigator-initiated PRC-approved clinical trials, abstracts/manuscripts intended for grant development
  3. 3. Non-peer-reviewed grants and clinical studies
  4. 4. Non-funded projects intended for abstracts and manuscripts, non-investigator initiated industry sponsored trials

We also give a high priority to teaching affiliated medical fellows, residents, and post-docs intent on pursuing research careers. Projects are addressed by the priority order on a time-available basis.

Supported by the Cancer Center grant, the Core collaborates on the development of protocols by Cancer Center members and on trainee’s career development work without requiring additional funding. Development of grant applications that include salary support for Core members are also supported without requiring additional funding. In all other cases, efforts will be made to find alternative funds and/or statistical support, for example, those provided by CTSI.
 

This unit is supported by a National Cancer Institute Cancer Center Support Grant (5P30CA082103). Any publications related to work done by this core should reference grant number 5P30CA082103 and must include a PMCID as required by the NIH. For complete instructions on how to acknowledge funding sources, please see http://grants.nih.gov/grants/acknow.htm. For more information on how to obtain a PMCID, please see http://publicaccess.nih.gov/submit_process.htm.

For more information on the CCSG, please contact Erin Bank, PhD, at erin.bank@ucsf.edu.