Core A: Administrative Core

Baylor College Of Medicine, Houston TX

Investigators

Abstract

Project Summary – Administrative Core (Core A) The proposed Specialized Programs of Research Excellence (SPORE) will investigate outcome disparities in Latino children and adolescents with acute lymphoblastic leukemia (ALL). The Program is built on a multiinstitutional consortium, the REducing Disparities in Acute Leukemia (REDIAL) Consortium, comprising 6 pediatric cancer centers in the southwestern United States, with large proportions of Latino children and adolescents with ALL. Core A, the Administrative Core, will oversee and coordinate all entities of the SPORE, which includes four Research Projects (Project 1, therapy-associated hepatotoxicity; Project 2, methotrexate neurotoxicity; Project 3, pharmacogenomics; and Project 4, patient-reported outcomes, epigenetics, and social determinants of health [SDoH]); Core B, the Biospecimen Processing and Storage Core; Core C, the Biostatistics and Data Management Core; Core D, a Community Outreach and Engagement Core; a Developmental Research Program (DRP); and a Career Enhancement Program (CEP). Collectively, this SPORE will generate insights into the contributions of ancestry, metabolomics, pharmacogenomics, epigenetics, SDoH, and other risk factors toward observed population-based disparities in treatment-related toxicities experienced by Latino children and adolescents with ALL. By facilitating employment, training, regulatory compliance, internal and external communication, and financial management of the SPORE, Core A will maximize the productivity and efficiency of all participating components. Under the leadership of Co-Directors Drs. Karen Rabin, Philip Lupo, and M. Monica Gramatges, Core A will be responsible for overseeing the conduct of the research at the various sites, including the regulatory, financial, and human resources aspects. Core A will also ensure regular internal communication among investigators and sites and organize external communication with leaders in the field, the scientific community, and patient advocacy organizations. Core A will (1) oversee all human resource management responsibilities, including creation of job descriptions and the hire, evaluation, and replacement of personnel locally and at the Consortium sites; (2) provide regulatory management and governance, including tracking regulatory submissions/approvals and assisting with necessary training of research staff; (3) control expenditures and maintain budget information for all Projects, Cores, and Consortium sites; and (4) facilitate internal and external communication among all participating Project Leaders, Core Directors, and sites to ensure adequate enrollment rates, address logistical issues, and present updates on research progress. Internal, External, and Community Advisory Boards (IAB, EAB, CAB) will be established. Both the IAB and EAB will include leaders in pediatric leukemia biology, genomics, epidemiology, supportive care, and patient advocacy, including two leaders of funded SPOREs. The IAB will meet twice yearly, the EAB annually, and the CAB quarterly. In summary, the Administrative Core will ensure that all aspects of the proposed research program are conducted in accord with the highest standards of organization, documentation, communication, and fiduciary responsibility