Biostatistics, Epidemiology, and Research Design (BERD)

The Delaware Valley Institute for Clinical and Translational Science (DVICTS) will establish mechanisms and processes that ensure the conduct of high-quality translational research through focus on precise and coordinated application of expertise in study design, data handling, biostatistics, and educational efforts across all the DVICTS partner institutions, investigators, and collaborators.

Overview and Goals of the Delaware Valley Resources for Biostatistics, Epidemiology, and Research Design (DVR-BERD): 4 institutional partners are collaborating to develop DVICTS: the University of Delaware (UD), Thomas Jefferson University (TJU), Christiana Care Health System (CCHS), and Nemours-specifically including the A. I. duPont Hospital for Children (Nemours/AIDHC). Each of the 4 partner institutions has significant individual strength in each area of translational research and education; however, overall effectiveness has been limited by the lack of organized inter- and intra-institutional coordination of translational activities.

DVICTS has established and will continue to develop the Delaware Valley Resources for Biostatistics, Epidemiology, and Research Design (DVR-BERD) to coordinate epidemiologic and biostatistical resources across the 4 partner institutions. DVR-BERD will have a comprehensive and responsive organizational structure to support clinical and basic science groups in T1 and T2 research and, especially to work in cooperation with the Delaware Valley Resources for Community Engagement and Research (DVR-CER), the Delaware Valley Resources for Participant and Clinical Interactions Resource (DVR-PCIR), and the Delaware Valley Resources for Biomedical Informatics (DVR-BMI), to develop T3 research in the State of Delaware and surrounding areas of Pennsylvania, Maryland, and New Jersey. These T3 resources, unique to our CTSA, will be important in (a) demonstrating the usefulness of outcomes achieved through research and evidence-based care and (b) showing that implementation studies can lead to better public and overall health. Because the demographics of the State of Delaware and the surrounding Delaware Valley mimic the nation at large, lessons learned here will be broadly applicable elsewhere. DVR-BERD will also be actively involved in educating and mentoring population scientists and developing new epidemiologic and biostatistical methods.

The specific objectives of DVR-BERD are as follows:

  • Objective 1: To adapt existing methods and develop new methods for translational and population science through multidisciplinary collaboration


  • Objective 2: To leverage advanced information technology systems to develop epidemiologic and implementation studies in the Delaware Valley


  • Objective 3: To drive the translational cycle by coordinating epidemiologic design, data handling, and biostatistical capabilities across the 4 DVICTS partner institutions and other collaborators


  • Objective 4: To educate and mentor the next generation of population scientists in the Delaware Valley


Leadership, Operational Structure, and Functions: By promoting active collaboration across institutions, the DVR-BERD will provide biostatistical, epidemiologic, and study design support for T1 to T3 research programs, and will organize and/or participate in education activities throughout DVICTS.

There are 4 major components to DVR-BERD structure:

  1. The DVR-BERD Oversight Committee: This committee will be composed of members of the DVICTS Operational Committee as well as major collaborators of DVR-BERD and will (a) conduct a regular review of resources, direction, and metrics (biannually in year 1 and annually thereafter) and (b) provide input to the DVR-BERD leadership team on DVICTS satisfaction and recommendations.


  2. The DVR-BERD Leadership team: The overall direction and leadership of the DVR-BERD will be provided by Dr. W. Weintraub, MD, Dr. P. Kolm, PhD, and T. Hyslop, PhD. Dr. Weintraub is a nationally and internationally recognized epidemiologist and clinical investigator in cardiovascular medicine with over 30 years of experience as an investigator. Dr. Weintraub is currently chair of the Division of Cardiology at Christiana Care, director of the Christiana Care Center for Outcomes Research (CCOR) and professor of Medicine at Thomas Jefferson University (TJU). Dr. Kolm is director of Biostatistics at CCHS and CCOR, and Research Professor of Medicine at Thomas Jefferson Medical College. Dr. Kolm has over 25 years experience in consulting with principal investigators in the design and analysis of clinical trials, retrospective and observational studies, and large patient registries and has published extensively on cost effectiveness analysis. Dr. Hyslop is associate professor, director of the Division of Biostatistics, and director of the Kimmel Cancer Center Biostatistics Shared Resource. Dr. Hyslop has 18 years of experience as a biostatistician, and has particular expertise in cancer, including biomarker studies, behavioral prevention trials, microarray and other genetic studies, and clinical trials. These individuals will be responsible for conducting an annual review of the number of projects, time demand, and productivity to inform modifications (if needed) to future funding strategies.


  3. Individual researchers and research teams: Individual researchers and research teams will be responsible for responding to requests from the DVR-BERD and addressing the Center's 4 objectives. They will be expected to collaborate across institutions and across areas of expertise. They will form the BERD Consultation Services (BERD-CS).


    4. The BERD-CS is designed to provide faculty, trainees, and students at all levels with convenient access to epidemiological and biostatistical support. The BERD-CS will be composed of 3 distinct entities:

    • The "Connector": a critical staff member who will be the person responsible for facilitating interface and connection. In addition to managing the on-line system for requesting services, this person will be responsible for maintaining a database of requests and projects, maintaining a catalog of researchers and their areas of expertise, announcing DVICTS opportunities, connecting students with projects for internships, facilitating the communication of collaborative work, and maintaining a portal. The connector will conduct a first level triage of structured requests and will send the requests to the appropriate subcommittee. The database will also document ongoing collaborations so that those can be automatically assigned to the appropriate set of DVR-BERD researchers.


    • A subcommittee for review of T1, basic science research projects.


    • A subcommittee for review of T2 clinical research and T3 population health research.


Each review committee will be composed of researchers with the appropriate expertise from each DVICTS institution, and will include at least 1 senior biostatistician, 1 clinical information technology or biomedical informatics specialist, 1 epidemiologist, someone with expertise in data management, and an IRB representative or Institutional Animal Care and Use Committee (IACUC) representative from the regulatory and ethics work group. The IRB or IACUC representatives will be present to provide advice to the Investigators regarding their IRB submission, with the goal of facilitating and shortening the review process but will not replace official IRB or IACUC review.

These review committees will be charged with prioritizing projects and assigning appropriate BERD researchers to projects deemed ready for implementation.