VCU Center for the Study of Tobacco Products

The Center’s Biostatistics Core will be led by Dr. Sun in partnership with the Department of Biostatistics that she chairs. The team also includes Brian Bush, and Miao-Shan Yen. Dr. Sun has an M.S. in Applied Mathematics and Statistics and a Ph.D. in Biostatistics and is expert in modeling complex cross-sectional and longitudinal data. The Biostatistics Core provide support that includes clinical trial design, sample size and power calculations, repeated measurements and longitudinal modeling. The Biostatistics Core is also responsible for management of the biostatistical aspects of the Center activities and will provide advice on issues involved in the design, conduct, analysis, and reporting of research projects.

The Biostatistics Core (a) provides front-end involvement writing grant proposals and works closely with Center investigators in the preparation of grant applications by (i) assisting Center investigators in developing and designing projects; (ii) performing analyses and assisting in the development of preliminary data sections; (iii) writing biostatistical sections of grant proposals that include sample size and power calculations, statistical analysis plans, data management, and clinical trial design and administration; and (iv) developing data collection instruments and (b) supports ongoing research: Biostatistical staff assist Center investigators (i) in all statistical aspects of clinical/biomedical studies; (ii) in clinical trial monitoring by performing interim analyses; (iii) in performing biostatistical analyses at the end of the study; (iv) in developing new methodologies if needed; and (v) in assisting with writing research results for publication. Examples of services provided by the Biostatistical team include: providing advice on the choice of an appropriate experimental design or analysis strategy, estimating the sample size required to detect a given effect with adequate power, assisting with development of analysis plans after an appropriate design has been determined, preparing a study analysis plan from the requirements of the study design, developing appropriate randomization and stratification procedures, assisting with the conduct of preclinical and clinical studies through provision of interim analyses, analyzing completed studies, statistical methodological and/or computational algorithm development to support specific aims. Dr. Sun will participate in meetings of the Executive Leadership Committee and DSMBs.

Center members contact the Biostatistical team via a web-based contact system (the Biostatistical Request for Services System). The request for services format includes the name of the investigator, contact information, declaration of Center membership, and services requested (from a drop-down menu with further explanation in a text box). Ms. Miao-Shan Yen, is the recipient of the request for services; she contacts Dr. Sun and tracks the contact date. Dr. Sun then works with Miao-Shan Yen to initiate the collaboration.

Biostatistical team use is tracked via a web-based Biostatistical Tracking System (developed using REDCap). The system is linked to the Biostatistical Request for Services System. The timeframe for response to the request for services is tracked in addition to the type of services provided. When a Biostatistical staff member has been identified to work with a Center investigator, the system will regularly (e.g., monthly) “ping” the staff member via email to update the status of the collaboration. We anticipate that the closeout of a project is not always clear. However, by requesting regular updates to determine if, for example, a requested consultation has occurred, or a manuscript has been submitted for peer review, or a grant has been submitted or funded, the ongoing status of the collaboration may be noted. The system will be designed to produce tables suitable for annual reports and grant renewal applications.

A natural product of collaborative partnerships formed between Center investigators and Biostatistical staff is one-on-one bi-directional training – investigators learn about appropriate statistical methods that accommodate their study designs, while Biostatistical staff learns more about the biomedical underpinnings of tobacco use and nicotine addiction.

  • Shumei Sun, Ph.D.
    Co-Investigator
  • Miao-Shan Yen, M.S.
    Statistician
  • Brian Bush, M.S.
    Data Manager