Clinical Protocol and Data Management

$438,868P30FY2025CANIH

Research Inst Of Fox Chase Can Ctr, Philadelphia PA

Investigators

Linked publications & trials

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Abstract

PROJECT SUMMARY/ABSTRACT â CLINICAL PROTOCOL AND DATA MANAGEMENT Clinical Protocol and Data management (CPDM) at Fox Chase Cancer Center (FCCC) is spearheaded by the Office of Clinical Research (OCR). The OCR provides central management, research support and oversight for the conduct of cancer-related clinical trials for the Cancer Center. OCR services are provided for all interventional treatment trials conducted at all Cancer Center treatment facilities. For non-treatment cancer relevant clinical research, the OCR facilitates study submission, ongoing management of study materials, annual reviews, as well as CTRP and clinicaltrials.gov reporting, as some researchers utilize research staff within their department to perform the conduct of the study. The OCR has a particular responsibility for institutional treatment trials developed by FCCC members; investigators have input from community reviewers to ensure clinical research is addressing the needs of the catchment area. During this grant period, we have redesigned the process for new study selection to better integrate multidisciplinary care within disease site teams (TRACSS). This has led to an improvement in the average accrual per trial, from 2.1 in 2021 to 6.7 at the end of 2023. In addition, overall accrual has increased with accruals to treatment and interventional trials in 2023 both on target to increase by 28% compared to 2019. We have made improvements to our study start up process, including establishing a Study Activations Unit, leading to decreased study activation timelines. In 2023, the median days to activation is 84 days for treatment trials, a 64% decrease in days required to open to accrual compared to 2019-2021. The Data Safety and Monitoring Plan has been revised to enhance risk-based monitoring of trials. We were awarded one of four SU2C Diversity in Early Development Clinical Trials Grants. The funds are enhancing the infrastructure at TUHS campus to improve our ability to enroll minority and socioeconomically disadvantaged cancer patients into cancer research studies leveraging the experience and infrastructure to the TUHS for phase I/II studies. Black, female and older adult patients (> 65 years) were appropriately represented in interventional trials relative to their respective proportion of the catchment area population.

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