# Clinical Protocol and Data Management

> **NIH NIH P30** · UNIVERSITY OF KANSAS MEDICAL CENTER · 2022 · $177,258

## Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT: ABSTRACT
The Clinical Protocol and Data Management (CPDM) function at The University of Kansas Cancer Center
(KUCC) resides within the Clinical Trials Office (CTO). The CTO, led by Tara Lin, MD (CTO Medical Director)
and Natalie Streeter (Assistant Vice Chancellor and Chief Operating Officer, Clinical Research, Strategy and
Operations) under the direction of Weijing Sun, MD, FACP (AD for Clinical Research), provides
comprehensive support services that span the life cycle of cancer clinical trials from concept through
manuscript. The CTO provides centralized protocol management and reporting, with strong emphasis on data
integrity, protocol compliance, education and training of CTO staff and investigators, and timelines for rapid
trial submission and activation. The CTO supports KUCC investigators through the Disease Working Groups
(DWG) to develop research portfolios that meet the needs of our catchment area. Enhancements to CTO
operations enabled the growth of clinical research, with particular focus on investigator-initiated trials (IITs),
early phase clinical trials and trials for underserved and rural populations. Cancer Center Program Leaders are
integrated into CTO committees including the Clinical Research Steering Committee and IIT Steering
Committee so that CTO functions best serve the needs of the individual programs and promote translation of
KUCC science to the clinic. The CTO expansion and staff specialization has enabled a steady increase in
clinical trial accrual. From 2016-2020, there were 13,575 accruals onto interventional, observational, and
ancillary/correlative studies. Accrual to interventional treatment clinical trials increased by 61% since the last
grant period (3,965 accruals in 2016-2020 verses 2,462 in 2011-2015). Accrual to NCTN protocols increased
overall by 111% (1,581 accruals in 2016-2020; 750 from 2011-2015). Our achievements led to our recognition
as an NCTN “High-Performing Site,” and awards of an NCORP grant and CATCH UP 2020 supplement
focused on rural and underserved populations. Our commitment to increase clinical trial outreach to local
community sites and the Masonic Cancer Alliance (MCA, network across Kansas and Missouri) resulted in
increased accruals by 62% since the last grant cycle (404 accruals in 2016-2020; 506 accruals in 2011-2015).
The creation of a dedicated IIT team within the CTO and the IIT Steering Committee resulted in an increase in
accruals to interventional treatment IITs by 151% since the prior grant cycle (1,645 accruals in 2016-2020; 656
in 2011-2015). In summary, the CTO has efficiently leveraged its resources to support the growth of clinical
research at KUCC, with a particular emphasis on developing IITs and bringing innovative and impactful clinical
trials to meet the needs of patients within our catchment area.

## Key facts

- **NIH application ID:** 10493593
- **Project number:** 2P30CA168524-11
- **Recipient organization:** UNIVERSITY OF KANSAS MEDICAL CENTER
- **Principal Investigator:** Tara Lin
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $177,258
- **Award type:** 2
- **Project period:** 2012-07-11 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10493593

## Citation

> US National Institutes of Health, RePORTER application 10493593, Clinical Protocol and Data Management (2P30CA168524-11). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10493593. Licensed CC0.

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