Vanderbilt Institute for Clinical and Translational Research

Design Biostatistics and Research Ethics Program

Biostatisticians and ethicists in the Design, Biostatistics, and Research Ethics core interact with the investigator at all stages of their VICTR submission. We strongly encourage investigators to interact with us at the very early stage of their study design.

Through biostatistics clinics, studios, and one-on-one sessions, we:

• Conduct consultations, focused on biostatistics and ethics, to improve study designs by using strategies to minimize bias, assure that necessary data relating to outcomes and confounding factors are recorded, and avoid common study mishaps.
• Work with investigators to ensure that the sample sizes are sufficient to meet the goals of the study and the plans for analysis are tenable in the context where the research will be published or discussed.
• Incorporate both well-established and novel study design methods that address efficiency, ethics, and impact of the results.
• Apply methods of reproducible statistical analysis and reproducible reporting, the ability to regenerate data investigations without guesswork.
• Emphasize collaboration and encourage "Extreme Consulting" and web-based communication.
• Practice methods of design and analysis that produce valid estimates of variation, instead of using naive methods that may appear easier to apply but result in misunderstanding of the results.
• Work to develop new statistical methods for non-conventional data analyses to serve VICTR projects.

The ultimate objective of the DBRE core of VICTR is to ensure optimal conduct of translational and clinical research.

For biostatistical assistance through VICTR (CTSA), apply for VICTR resources by going to https://www.mc.vanderbilt.edu/starbrite/funding.

For additional information, please contact Li Wang at (615)343-8654 or email li.wang@vanderbilt.edu.

Personnel

Biostatistics

• Frank E Harrell Jr, PhD, Director, DBRE, Co-Program Director, VICTR
• Dan Byrne, MS, Senior Associate in Biostatistics
• Chang Yu, PhD, Assistant Professor
• Li Wang, MS, Biostatistician II
• Terri Scott, MS, Biostatistician III
• Dana Blakemore, MS, Biostatistician II
• Sharon Phillips, MS, Biostatistician III (for Section of Surgical Sciences)

Biomedical Research Ethics

• Larry R. Churchill, Ph.D., Ann Geddes Stahlman Professor of Medical Ethics, Center for Biomedical Ethics & Society
• Elizabeth Heitman, PhD, Associate Professor, Center for Biomedical Ethics and Society
• Kirk B. Lane, PhD, Research Assistant Professor, Allergy/Pulmonary & Critical Care Med Division
• Ellen Wright Clayton, MD, JD, Rosalind E. Franklin Professor of Genetics and Health Policy, Professor of Pediatrics, Professor of Law, Director-Center for Biomedical Ethics and Society