# Clinical Protocol and Data Management

> **NIH NIH P30** · CASE WESTERN RESERVE UNIVERSITY · 2021 · $595,586

## Abstract

CLINICAL PROTOCOL AND DATA MANAGEMENT 
PROJECT SUMMARY/ABSTRACT 
The Case Comprehensive Cancer Center (Case CCC) is committed to the translation of laboratory insights into 
routine clinical care. This requires a deep infrastructure to support the conduct of clinical trials of new 
interventions designed to prevent, diagnose and treat cancer, and improve the long-term outcomes for cancer 
survivors. The Clinical Protocol and Data Management services of the Case CCC provide a centralized resource 
for the oversight and management of clinical trials from concept development through reporting of study results. 
Services include assistance with concept development and protocol writing; feasibility assessment; budgeting 
and contracting; research nursing and data management; database development and oversight; regulatory 
management including IND applications; interactions with sponsors; study registration; quality assurance; staff 
education; and reporting of results. Data and safety monitoring to ensure the integrity of data and patient safety 
is a critical centralized function. As our goal is to ensure access to clinical trials for all of our patients, special 
efforts are undertaken to provide the opportunity to participate in clinical trials regardless of sex/gender, race, 
ethnicity, socioeconomic status, or age. The Specific Aims are to: 
 1) Provide a highly efficient and coordinated infrastructure to assist clinical investigators in the development, 
 conduct and reporting of clinical trials. 
 2) Oversee data integrity and ensure the safety of patients who participate in clinical trials. 
 3) Provide access to clinical trials for all cancer patients regardless of sex/gender, race, ethnicity, age, and 
 socioeconomic status, and proactively identify and address barriers to clinical trial participation among 
 patients, providers, research staff, and healthcare systems. 
 4) Support a robust portfolio of research studies relevant to children and address special considerations for 
 children with cancer to facilitate their participation in clinical trials. 
In 2016, 2,474 patients were enrolled onto Case CCC interventional trials (73 percent increase since 2012), 
including 866 patients on treatment studies. In 2016, thirty one percent of accruals to treatment studies and 
seventy percent of all interventional accrual was to investigator-initiated trials (peer-reviewed, institutional). There 
is a substantial commitment to support of National Clinical Trials Network (NCTN) studies, with 209 patients 
accrued to treatment intervention studies in the third year of the NCTN. Furthermore, in 2016 the Case CCC 
enrolled and biopsied 93 patients on the NCI MATCH trial, supported by the Clinical Trials Units via rapid 
activation, centralized registration, and coordination of tissue acquisition and processing. 
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## Key facts

- **NIH application ID:** 10135962
- **Project number:** 5P30CA043703-31
- **Recipient organization:** CASE WESTERN RESERVE UNIVERSITY
- **Principal Investigator:** Aaron Thomas Gerds
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $595,586
- **Award type:** 5
- **Project period:** 1997-08-01 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10135962

## Citation

> US National Institutes of Health, RePORTER application 10135962, Clinical Protocol and Data Management (5P30CA043703-31). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10135962. Licensed CC0.

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