Clinical Protocol and Data Management

Ohio State University, Columbus OH

Investigators

Linked publications, trials & patents

Abstract

PROJECT SUMMARY - CLINICAL PROTOCOL AND DATA MANAGEMENT Part I: Clinical Protocol and Data Management (CPDM). CPDM facilitates all clinical cancer research at The Ohio State University Comprehensive Cancer Center (OSUCCC) and is responsible for 14,996 interventional (5,648 interventional therapeutic) accruals over the reporting period. The CPDM has three major components: the Clinical Trials Office (CTO), the Quality Assurance (QA) Office and the OSUCCC Data and Safety Monitoring Plan (DSMP). Oversight is provided by the Associate Director for Clinical Research (ADCR), William Carson, MD, who also is serving as the interim CTO Medical Director. Dr. Carson supervises the CTO Administrative Director, Angela Campbell, MS, assisted by the Executive Director for Administration, David Gosky, MA, MBA. The CTO provides investigators with centralized expertise and support for the implementation, coordination and execution of cancer clinical trials. The CTO staff focuses on OSUCCC’s mission, vision and values to support investigators in the highest quality clinical cancer research with adherence to all federal and state guidelines. Part II: Data and Safety Monitoring. All cancer clinical trials conducted by OSUCCC investigators include oversight of data and safety monitoring. The OSUCCC Data and Safety Monitoring Plan (DSMP), approved by the NCI and last revised August 1, 2018, provides guidance for the conduct of cancer clinical trials in accordance with NCI CCSG requirements. The Data and Safety Monitoring Committee (DSMC), chaired by Beth Christian, MD, assures patient safety and protocol compliance by OSUCCC investigators and staff, and has monitored 413 trials during the reporting period. The independent control function for OSUCCC studies is provided by the Quality Assurance Oversight Committee (QAOC), which has audited 180 trials over the reporting period. Part III: Inclusion of Women and Minorities in Clinical Research. OSUCCC leadership, investigators and staff are committed to the inclusion of women and minorities in cancer clinical trials. Oversight of the inclusion of diverse populations in cancer clinical trials is the responsibility of Dr. Carson, who is assisted by Electra Paskett, PhD, Associate Director for Population Sciences and Community Outreach and Director of the Center for Cancer Health Equity (CCHE). Outreach to women and minorities is led by CCHE staff who educate the community about OSUCCC programs, services and the value of clinical trials. Part IV: Inclusion of Individuals Across the Lifespan in Clinical Research. The inclusion of individuals across the lifespan in cancer clinical research is an important goal of the OSUCCC. Nationwide Children’s Hospital (NCH) is the pediatric arm of the OSUCCC and is committed to making clinical trials available to children with a cancer diagnosis. It is the policy of the OSUCCC that individuals of all ages, including children and older adults are included in cancer clinical trials. In summary, the OSUCCC facilitates clinical cancer research, and provides quality, safety and monitoring of all trials with an emphasis on the inclusion of women, minorities, other underserved populations and individuals across the lifespan in its catchment area (the State of Ohio).