# Clinical Protocol and Data Management

> **NIH NIH P30** · WAYNE STATE UNIVERSITY · 2022 · $609,792

## Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT (CPDM) - ABSTRACT
The Karmanos Cancer Institute Clinical Trials Office (CTO) serves as a centralized resource providing CPDM
services and support to the Cancer Center with the highest priority being the safety of participating patients.
The CTO provides comprehensive regulatory support from protocol conception to activation, including liaison
and communication with the all applicable Institutional Review Boards (IRBs) and sponsors to facilitate timely
initiation and completion of clinical trial activities, all approval and review processes with the IRB,
Investigational New Drug (IND) support, registration of new trials with NCI Clinical Trials Reporting Program
(CTRP) and appropriate registration and results reporting with ClinicalTrials.gov. CPDM services facilitate and
optimize accrual by providing centralized and trained data management and research nurse support to KCI
physicians and clinical support staff. The CTO interfaces with several Shared Resources to facilitate and
enhance collaboration, improve processes and ensure efficient and effective use of resources. The Clinical
Trial Management System OnCore® is utilized to administer all clinical trial requirements. The CTO supports
National Clinical Trials Network, NCI-funded peer reviewed, investigator-initiated, and industry sponsored
protocols. KCI/WSU is a Lead Academic Participating Site under the NCTN (UG1CA233163). Effective quality
control and training is provided by the CTO to ensure compliance to the Data and Safety Monitoring Plan
(DSMP). This includes coordination and administrative support to the Feasibility Review and Operations
Committee (FROC), Protocol Review and Monitoring Committee (PRMC), the Data and Safety Monitoring
Committee (DSMC) and the Quality Assurance Committee (QAC).
During the current grant period the number of CTO staff increased from 108.85 to 154.45 FTE, providing
CPDM services in support of over 500 active protocols at any one time. The number of Network sites offering
clinical trials increased by 33% resulting in a 6.8-fold increase in accruals to interventional trials at KCI Network
sites (94 in 2015 to 641 in 2019). Strong Network site accruals led to an increase in NRG Lead Academic
Participating Sites (LAPS) trial accrual ranking to #3 for 2019. Efforts toward reduction of protocol activation
times led to a 2.8-fold decrease in median activation time from 213 days in 2017 to 75 days in November of
2019. KCI supports multiple, proactive efforts to promote the recruitment of women and minorities. These
efforts have resulted in exceptional enrollment of minorities and women to interventional trials over the current
grant period with 24.2% accrual of minorities and 58.1% accrual of women in 2019. KCI partners with
Children’s Hospital of Michigan (CHM) to facilitate pediatric accrual to clinical trials. Pediatric cancer specialists
at CHM actively participate as a member institution of the Children’s Oncology Group (C...

## Key facts

- **NIH application ID:** 10348670
- **Project number:** 5P30CA022453-40
- **Recipient organization:** WAYNE STATE UNIVERSITY
- **Principal Investigator:** Anthony Frank Shields
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $609,792
- **Award type:** 5
- **Project period:** 1997-08-08 → 2025-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10348670

## Citation

> US National Institutes of Health, RePORTER application 10348670, Clinical Protocol and Data Management (5P30CA022453-40). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10348670. Licensed CC0.

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