Clinical Protocol and Data Management

University Of Tx Md Anderson Can Ctr, Houston TX

Investigators

Linked publications, trials & patents

Abstract

ABSTRACT CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) The overall goal of Clinical Protocol and Data Management (CPDM) is to provide high-quality infrastructure support for all aspects of clinical protocol research at MD Anderson. The services of the CPDM, directed by Dr. Aman Buzdar, Associate Director for Clinical Research Administration, include support of single- and multi- center clinical trials through the protocol lifespan; human subject/clinical research education; auditing and monitoring active clinical trials; assuring regulatory compliance of IND studies; facilitating protocol financial management; and supporting biospecimen research. The CPDM complements the activities of the Protocol Review and Monitoring System (PRMS) by supporting the electronic protocol submission and evaluation processes. A Protocol Systems Legacy Refresh Project (PSLR) was undertaken in 2016 to migrate functionality of the legacy systems to a more contemporary, stable platform. The new electronic health record (EHR) system OneConnect (Epic), launched in March 2016, provides an integrated clinical, research, and business platform, with 2,188 interventional protocols and 102,134 patients now linked to the EHR. During the last 6 years, the total number of protocols managed by CPDM has increased from 5,018 in FY2012 to 5,974 in FY2017 (an increase of 19%). New patient registrations to interventional and non-interventional trials have averaged about 35,000 per year; however, a significant reduction was noted in the level of FY2016 and FY2017 accruals (24,676 and 26,568, respectively), largely due to efforts made to ensure a smooth implementation of OneConnect. Importantly, MD Anderson investigators have enrolled 739 patients to the NCI's National Clinical Trial Network (NCTN) protocols between March 2014 (year 1 of MD Anderson's Lead Academic Participant Site grant) and February 2017. Lastly, from March through August 2018, the Office of Clinical Research Administration underwent a substantive evaluation of all departments and functions, resulting in a revised organizational structure and greater emphasis on integration and accountability across departments to enhance efficiencies within related processes and ensure ongoing performance improvements. The goals of the CPDM are achieved through the following Specific Aims: Aim 1: Clinical Protocol and Data Management: To provide central management and oversight of all aspects of clinical protocol research at MD Anderson. Aim 2: Data and Safety Monitoring: To provide centralized resources for data monitoring, verifying data validity and integrity, and ensuring the safety of study participants in clinical trials. Aim 3: Inclusion of Minorities and Women in Clinical Research: To evaluate, monitor, and enhance the recruitment and retention of women and minorities in MD Anderson clinical research. Aim 4: Inclusion of Children in Clinical Research: To ensure the inclusion of pediatric oncology patients in all MD Anderson clinical trials, except if scientifically and ethically inappropriate.