Behavioral Trials Office (BTO)

The Behavioral Trials Office (BTO), housed in the Center for Biobehavioral Health, is a point of entry service for social and behavioral clinical trials at Nationwide Children's, connecting investigators to resources throughout the Abigail Wexner Research Institute, including Clinical Research Services, the Office of Technology Commercialization and more. Certified Clinical Research Professionals, clinical staff including nurses, nurse practitioners and biostatisticians in the BTO work with investigators to support efficient coordination of services necessary to initiate, implement, and disseminate clinical trials according to Good Clinical Practice and federal, state, and institutional regulations and guidelines.

Services we provide for social and behavioral trials include:

Study Implementation Services

Study Implementation Services such as participant scheduling; informed consent; data collection; intervention implementation; participant payment; OnCore and ClinCard management. 

Regulatory Services

Regulatory Services such as protocol support and development, IRB preparation, submission, and oversight; assistance creating and maintaining the study regulatory binder and manual of procedures; guidance with meeting clinicaltrials.gov registration and reporting requirements; study monitoring services; coordinating research and data agreements.

Clinical Safety Services

Clinical Safety Services such as clinical protocol development; adverse event plan development; adverse event collection and reporting; liaising with clinical departments; inclusion and exclusion criteria assessment; medical chart abstraction; biospecimen sample collection and storage.

Data Services

Data Services such as database design, creation and oversight; data reliability checks and cleaning; randomization; interim and final analysis; study design and analysis consultation; power calculation.

 

The BTO also provides clinical research education, training, and onboarding for staff engaged in social and behavioral clinical trials and maintains a repository of documents and NIH templates to support clinical trial grant development and regulatory aspects of clinical trial oversight. The coordination of these supports in a centralized resource increases the pace, rigor, and translation of social and behavioral clinical trials by efficiently supporting all aspects of complex single- and multi-site trials.

Meet Our Team

The BTO team collaborates with research teams to provide the highest standard of services for social and behavioral trials. The research professionals’ skills in project management, methodology, biostatistics and study coordination allow them to support the viability of complex single and multi-site clinical trials.

Nationwide Children's Hospital Medical Professional

Joseph Rausch, PhD
Director

Dr. Joseph Rausch received his PhD in Quantitative Methods from the University of Notre Dame. Dr. Rausch is a quantitative methodologist and Principal Investigator within the Center for Biobehavioral Health and a Research Associate Professor of Pediatrics at The Ohio State University College of Medicine. His primary research focus is the analysis of longitudinal data within randomized clinical trials and prospective research studies. Prior to joining Nationwide Children's Hospital in 2015, Dr. Rausch was faculty at the University of Minnesota and the University of Cincinnati College of Medicine and Cincinnati Children's Hospital Medical Center. Dr. Rausch has served as a methodologist on over 80 peer-reviewed publications and more than 20 federally funded projects in the field of pediatrics, including providing mentorship on several NIH research career development awards and serving as the primary biostatistician on randomized clinical trials.

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Kelly M. Boone, MA, CCRP
Associate Director

Kelly Boone received her MA in Developmental Psychology from the University of Kansas and obtained her Certified Clinical Research Professional (CCRP) certification from the Society of Clinical Research Associates. Kelly brings more than 10 years of experience managing behavioral trials, both in CBH and internationally. Prior to this position, Kelly was the Associate Director for Research at OSU's Schoenbaum Family Center and Crane Center for Early Childhood Research and Policy. There she provided the day-to-day leadership of the organization, with the goal of advancing their shared mission of improving children's learning and development at home, in school, and in the community.  Kelly also served as a research coordinator for many years. She managed studies examining DHA supplementation in toddlers born preterm and coordinated a multi-component school readiness intervention for children aged 0-5 years living in designated disadvantaged areas of Dublin, Ireland. 

Nationwide Children's Research Staff

Jen Filipkowski
Clinical Research Coordinator

Jen Filipkowski joined the Behavioral Trials Office at Nationwide Children’s Hospital in 2021. In her role, she coordinates social and behavioral clinical trials and studies.

Jen received her bachelor’s degree from the University of Dayton with a major in Child Development and a concentration in Social Work. After teaching for several years, Jen transitioned to research at The Ohio State University where she coordinated studies funded by the Institution of Education Sciences (IES) and the National Institute of Health (NIH) focused on improving educational outcomes for underserved children and their families.

Jen Filipkowski

Kenisha Hicks
Clinical Research Coordinator

Kenisha Hicks graduated from Grand Valley State University in 2016 with a bachelor's degree in Biomedical Science. After graduating, she worked for three years at the University of Illinois in Chicago, where she supervised a team of research associates and recruited and enrolled participants for National Institutes of Health (NIH) funded research. Kenisha then joined Nationwide Children’s Hospital as a research coordinator for the Behavioral Trials Office, where she assists with regulating and implementing interventional studies.