Program Description

Studies in humans rest on the fundamental respect for the individual. Therefore, it is unethical to perform studies that are poorly designed or with inappropriate statistical power, as this may put individuals at risk without any benefit. Therefore, research design, biostatistics and ethics are intrinsically linked. The UC Davis CTSC fosters an environment in which clinical and translational research will flourish on a sound methodological and ethical foundation. Through the CTSC Design, Biostatistics and Clinical Research Ethics program, investigators are educated and guided to undertake appropriately designed studies to test novel hypotheses. Furthermore, this core develops new research programs to improve current design and biostatistics methodology.

The Design, Biostatistics, and Clinical Research Ethics Resource provides the infrastructure and undertakes innovative methodological developments to foster a bridge between basic, translational, and clinical research. Critical support for clinical and translational research will be provided by achieving the following specific objectives:

• Optimize the design and analysis of observational studies, translational experiments, and clinical trials.
• Educate, mentor, and train investigators in research design, biostatistics, and clinical research ethics.
• Develop novel methodology for clinical and translational research.
• Assure a high standard of clinical research ethics.
• Develop logistics and infrastructure for efficient use of the resource.
• Integrate this program with other components of the CTSC.