CTSU eCourse: Learn About the CTSU

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OBJECTIVE 1: CTSU GOALS, BENEFITS, AND ORGANIZATION

The Cancer Trials Support Unit is a project sponsored by the National Cancer Institute (NCI) and the Cancer Therapy Evaluation Program (CTEP). It evolved from deliberations of the Clinical Trials Implementation Committee, created in late 1997 in response to a 1996 recommendation from the Armitage Committee. The CTSU is designed to be a web-based operation to support Cooperative Group functions and to establish a national network of physicians who participate in NCI sponsored Phase III adult cancer treatment trials.

Section topics include:

	CTSU Goals
	CTSU Benefits
	CTSU Organization

Module Objectives
1	Identify the goals, benefits, and organization of the CTSU project
2	Explain the major features of the CTSU financial system
3	State the treatment credit assignment process for the Community Clinical Oncology Program
4	Identify Regulatory Support System (RSS) procedures, required documentation, and a new submission procedure
5	Explain the availability of several web-based educational and promotional tools

CTSU Goals

Provide a diverse menu of Phase 3 (and occasional phase 2) adult clinical research trials for several malignancies, including the following:

	Head and Neck		Gynecological		Breast		Lung		Melanoma		Sarcoma
	Gastrointestinal		Genitourinary		Leukemia		Lymphoma		Multiple Myeloma

Facilitate participation by Cooperative Group investigators in trials not on their Groups' menus of trials

Facilitate participation in clinical trials by investigators who are not members of a Cooperative Group

Eliminate redundant administrative tasks for Cooperative Group members

Efficiently direct funding to the accruing sites to reimburse the cost of conducting clinical trials

Increase patient accrual in adult cancer Phase 3 clinical trials led by the Cooperative Groups

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CTSU Benefits

The CTSU offers opportunities for both physicians and patients to participate in cancer clinical trials nationwide. The CTSU has implemented the following initiatives:

Facilitate access for the general public and health care providers interested in participating in cancer clinical trials

Provide financial reimbursement for each accrued patient or funding credit for Community Clinical Oncology Program (CCOP) patients

No accrual minimum. (Exception: CTSU Independent Research Sites (CICRS) must accrue 5 patients per year onto studies through the CTSU)

No registration fee

Access to Phase 3 (and occasionally phase 2) trials on the CTSU menu led by the following Cooperative Groups as long as the protocol is reviewed by CTEP, NCI:

	American College of Surgeons Oncology Group (ACOSOG)		National Surgical Adjuvant Breast and Bowel Project (NSABP)
	Cancer and Leukemia Group B (CALGB)		North Central Cancer Treatment Group (NCCTG)
	Eastern Cooperative Oncology Group (ECOG)		Radiation Therapy Oncology Group (RTOG)
	Gynecologic Oncology Group (GOG)		Southwest Oncology Group (SWOG)
	National Cancer Institute of Canada Clinical Trials Group (NCIC CTG)

Access to trials led by other groups or cancer centers as long as the protocol is reviewed and approved by CTEP, NCI:

International Breast Cancer Study Group (IBCSG)

MD Anderson (MDA)

Web-based access to protocol related documents and forms

Protocol-specific IRB submission application templates

Protocol-specific audit worksheets

Access to expertise in the following areas: clinical trials, information technology, data management, protocol design and regulatory affairs

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CTSU Organization

The CTSU is managed jointly by staff from the National Cancer Institute, Westat (prime contractor), and the Coalition of Cancer Cooperative Groups (subcontractor). The CTSU is organized into the following areas:

Site Performance Management	Conducts audits of clinical sites according to the NCI's Clinical Trials Monitoring Branch guidelines. Develops and maintains a system to track site performance in terms of data quality and timeliness.
Clinical Trials Management System (CTMS)	Operates and maintains a comprehensive system for the management of clinical trials data; often referred to as Data Management.
Promotion, Education, and Training (PET)	Educates investigators and research teams about the CTSU and develops protocol-specific educational and promotional materials.
Financial Management	Maintains the Financial Management Database and a system to ensure that physicians/investigators are reimbursed in a timely manner.
Informatics	Maintains and enhances the CTSU enterprise (the series of interconnected clinical trials management tools maintained by the CTSU that include the web site, the regulatory support system, the clinical trials management system, and the financial management system); develops additional informatics systems that accomplish the goals of the CTSU.
Regulatory Support Services	Maintains a regulatory database to centralize regulatory functions for the nine sponsored adult Cooperative Groups and the CTSU. In addition, the regulatory database centralizes regulatory functions such as investigator registration, and coordinates protocol-specific site registration.
CTSU Independent Clinical Research Site (CICRS) Program	Oversees this program that provides access to CTSU menu trials to investigators that are not Cooperative Group members.
Customer Service	Operates and maintains the CTSU Help Desk, the CTSU Patient Registrar Service, and the CTSU Membership Service.
Web Site	Operates and maintains both the CTSU Public and CTSU Members' web sites.
Study Coordination	Oversees and coordinates CTSU menu trials that are being conducted under the Comprehensive level of data management, whereby the CTSU performs most or all data management activities on behalf of the Lead Group.

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