Clinical Protocol and Data Management

University Of Pennsylvania, Philadelphia PA

Investigators

Linked publications & trials

Abstract

The CPDM is the administrative home for support and monitoring of all clinical research conducted in the ACC regardless of the type of intervention or sponsor. The CPDM creates, directs and enforces the operational policies and expectations for the conduct of all cancer-related clinical research within the ACC across the University of Pennsylvania. The CPDM scope is of necessity broad, encompassing and implementing policies and procedures, education and training, supervision of data managers and research nurses, and oversight over the specialty clinical research units (CRUs) that are a vital part of our Center. The CPDM oversees first-stage and second-stage protocol review, manages our centralized clinical trials management system (Velos), performs monitoring and auditing of clinical trials, and manages the complex activities of our mandatory clinical research review committees. Key elements within the CPDM are the Department of Operations, Compliance and Monitoring (DOCM), the Protocol Review and Monitoring System (PRMS, known as the Clinical Trials Scientific Review and Monitoring Committee [CTSRMC]), the Data and Safety Monitoring Committee (DSMC), and Office of Legal Affairs, along with our disease and discipline-specialized CRUs. The DSMC is responsible for ensuring that all cancer-related human subjects studies abide by all Federal regulations and institutional policies as well as our NCI-approved ACC Data and Safety Monitoring Plan (DSMP) to ensure subject safety and study integrity. The DSMC complements yet functions completely independently of CTSRMC. The DSMC has independent oversight responsibility for all activated CTSRMC-approved protocols, serves as the parent committee for the ACC DSMP, and sets policies, standards and expectations for all aspects of monitoring, auditing and pharmacovigilance for adult and pediatric studies. Key initiatives in the current funding period include improved times for protocol activation (50% shorter compared to 2015), improved data tracking systems, enhanced operations of the CRUs, and a new leader and coordinator for NCTN trials. The result overall has been a 116% increase in average annual accruals to interventional trials during this funding period compared to the last (20% increase for treatment; 314% increase in non-therapeutic interventional). Ensuring representative enrollment onto clinical trials continues to be a central goal for the ACC, part of our commitment to address the cancer burden in our catchment area. Extensive efforts during this funding period have resulted in full representation of participants on ACC clinical trials. Lifespan. The ACC supports participation of patients of all ages in clinical trials. Our CTSRMC will not approve protocols that exclude children or the elderly without a compelling rationale. We benefit from a fully embedded Pediatric Oncology Program that performs innovative clinical trials for nearly all childhood malignancies, with members who lead the pediatric National Group.