A Web Based System That Offers Efficient and Effective Tools for Clinical Trials Management
In 1996, the National Cancer Institute (NCI) and its Board of Scientific Advisors convened the Clinical Trials Program Review Group to evaluate NCI-sponsored, extramural clinical trial programs. Based on the Review Group’s recommendations, the NCI created a pilot project called the Cancer Trials Support Unit (CTSU).
The CTSU aims to increase physician and patient access to Phase III cancer treatment trials, most of which are led by the Clinical Trials Cooperative Groups. One of the ways the CTSU accomplishes this is through providing cross-Group access to selected Phase III NCI-sponsored trials. This means Cooperative Group members are able to enroll eligible patients for any CTSU trial that is not available through their own Cooperative Group. Currently, the CTSU has 40 active studies and 40 studies in development. Initially, the CTSU protocol menu included protocols from 5 disease areas – gastrointestinal, genitourinary, lung, breast, and adult leukemia; however, the CTSU has expanded to include other diseases such as melanoma, head & neck, multiple myeloma, and some rare cancers.
Beginning May 18, 2002, the CTSU opened its protocol menu to qualified medical, radiation, and surgical oncologists and hematologists within the USA who are not Cooperative Group members. The new policy allows cancer patients anywhere in the USA to participate more easily in advanced (Phase III) treatment trials. More information can be accessed on the public side of the CTSU web site (http://www.ctsu.org).
A unique aspect of the CTSU is its foundation in the web. All CTSU members have access to protocols, protocol-specific forms, and patient educational materials on the members’ side of the CTSU web site (http://members.ctsu.org/). Protocol-specific materials that are provided on-line include the following: IRB submission application template, protocol overview, protocol-specific time and events schedule, protocol instructions, a pocket-sized protocol card that outlines the eligibility requirements and treatment plan and Patient Education Pages (PEPs) that explains patients options for treatment in a patient-friendly language.
An important benefit of the CTSU has been the availability of several web-based educational offerings. These training programs and tools can facilitate the enrollment of patients on CTSU trials. The CTSU offers an on-line educational program that can be accessed via the public side of the web site (http://members.ctsu.org/) called eCourse. This program provides both novice and experienced research staff with a convenient method of learning about participation in clinical trials through the CTSU. A CTSU process checklist is also available on the web site as an easy-to-follow flowsheet that provides instructions on how to successfully register and enroll a patient via the CTSU. A Frequently Asked Questions (FAQ’s) link offers answers to common questions about the CTSU.
Also, the CTSU offers a Patients Page on the public side of the web site. This page contains resources specifically for patients seeking information about cancer and available clinical trials, including links to: NCI web sites that offer disease-specific, treatment, and support information for patients, information on health insurance with links to many of the major providers, a printable list of all currently active protocols on the CTSU menu, Cooperative Group web sites, and protocol abstracts from the National Cancer Institute's PDQ database, including access to patient and health professional versions of the abstracts.
For more information, visit the CTSU web site at www.ctsu.org, contact the CTSU Help Desk at 1-888-823-5923 or by email at CTSUContact@westat.com.