Clinical Protocol and Data Management

$438,868P30FY2025CANIH

Research Inst Of Fox Chase Can Ctr, Philadelphia PA

Investigators

Linked publications, trials & patents

Paper 39604567 Paper 39602533 Paper 39554190 Paper 39546469 Paper 39521739 Paper 39514554 Paper 39371220 Paper 39345610 Paper 39343653 Paper 39223207 Paper 39207123 Paper 39189642 Paper 39148468 Paper 39137728 Paper 39072643 Paper 39060143 Paper 39013784 Paper 39003201 Paper 38982062 Paper 38976159 Paper 38963567 Paper 38914477 Paper 38871720 Paper 38865671 Paper 38853421 Paper 38835516 Paper 38815457 Paper 38811332 Paper 38798370 Paper 38766032 Paper 38747616 Paper 38678525 Paper 38659828 Paper 38639476 Paper 38638131 Paper 38600381 Paper 38586274 Paper 38586042 Paper 38559274 Paper 38547779 Paper 38539515 Paper 38464238 Paper 38452871 Paper 38432028 Paper 38421650 Paper 38377387 Trial NCT04290585 Trial NCT03177057 Trial NCT02594826 Trial NCT02132884 Trial NCT02132858 Trial NCT02132845 Trial NCT02110953 Trial NCT02092714 Trial NCT02050009 Trial NCT01982591 Trial NCT01962948 Trial NCT01934179 Trial NCT01840150 Trial NCT01462630 Trial NCT01316757 Trial NCT01212822 Trial NCT00750009 Trial NCT00509626 Trial NCT00458588 Trial NCT00436397 Trial NCT00433524 Trial NCT00084591 Trial NCT00084539 Trial NCT00084526 Trial NCT00084513 Trial NCT00066677 Trial NCT00062322 Trial NCT00062309 Trial NCT00043108 Trial NCT00039520 Trial NCT00039507 Trial NCT00022308 Trial NCT00021398 Trial NCT00021372 Trial NCT00021346 Trial NCT00021333 Trial NCT00021320 Trial NCT00005037 Trial NCT00003264 Trial NCT00003263 Trial NCT00003109 Patent 9533040 Patent 9182383 Patent 9101603 Patent 8980258 Patent 8685658 Patent 8609437 Patent 8580263 Patent 8329873 Patent 7332585 Patent 7332580 Patent 7129057 Patent 6946275 Patent 6617427

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.

View original record on NIH RePORTER →