Biostatistics, Epidemiology, & Research Design (BERD) and Research Ethics
The Biostatistics, Epidemiology, and Research Design (BERD) and Research Ethics program is created to provide a one-stop point-of-access for biostatistics, research design, and clinical research ethics, which offers comprehensive expertise to meet the increasingly complex demands of clinical and translational research. It provides investigators with coordinated and integrated support through stages from conceptualization and design, to planning and implementation, and to analysis, interpretation, and dissemination.
The program matches investigators with faculty members of appropriate expertise to help answer the following key research questions:
- Are the primary endpoints clearly defined?
- Are the primary hypotheses clearly stated?
- Is the sample size justified?
- Is there a clearly specified, appropriate data analysis plan?
- Are the assumptions used for sample size estimation and the analysis plan clearly elaborated and supported by proper preliminary data and/or references?
- Does the protocol have an appropriate research design and statistical analysis section?
- Is there any ethical challenge that might arise during the execution of the research protocol?
The BERD program also contributes to the data and safety monitoring plans for clinical studies, particularly with respect to interim analysis or pre-established early stopping.
Advances in clinical and translational research require corresponding advances in statistical and design methodologies. Through connections with other research institutes in the Dallas / Fort Worth metropolitan area such as Southern Methodist University, the University of Texas at Dallas, and the University of North Texas Health Sciences Center, the Biostatistics, Epidemiology, and Research Design program has been facilitating the generation and dissemination of new research ideas through establishing professional collaborations, presenting and participating in seminars, and jointly mentoring Ph.D. students.
The major areas of methodology research conducted by faculties from the program include:
- New design approaches to clinical trials with clustered measurements, longitudinal measurements, missing data, historical controls, and cost consideration;
- Adaptive clinical trial designs for Phase I dose-ranging studies of vaccines or single dose drugs requiring repeat administration and flexible designs for interim monitoring of safety and efficacy endpoints in studies involving multiple endpoints;
- Computationally intensive methodologies to analyze data arising from high-throughput experiments, including microarray, genetic, brain imaging, and next generation sequence data, with the additional challenge of incorporating biological knowledge (e.g., Gene Ontology knowledgebase, 3D structure of DNA, etc.) into the analysis;
- Novel statistical methods that utilize electronic medical records and large national database to support clinical decision making, including building of clinical risk prediction models; and
- Novel statistical methods for the design and analysis of community intervention trials.