Cancer Trials Support Unit Ctsu

In an attempt to improve the rate of accrual to phase 3 trials, and to leverage advances in technology and communications, NCI created the Cancer Trials Support Unit. Its primary goals are to centralize regulatory support for Cooperative Group trials, previously maintained separately by the eight adult Cooperative Groups, and to establish a national network of physicians who can participate in NCI sponsored phase 3 adult cancer treatment trials, without regard for their individual Group affiliation.

The CTSU has increased physician and patient access to Phase 3 adult cancer treatment trials, the majority of which are led by the Cooperative Groups. Cooperative Group members are able to enroll eligible patients for any trial on the CTSU menu that is not available through their own Cooperative Group. For example, if a SWOG member is interested in a study on the CTSU menu that is being conducted by GOG, the SWOG member can open the study at their site through the CTSU.

This system appears to have broad appeal, as the number of accruals through the CTSU has steadily increased (Figure 12). During the past twelve months, the cumulative accrual through the CTSU since its inception in 1999 has nearly doubled, from 5000 to almost 10,000 patients. Additionally, using the CTSU as a readily available mechanism for collaboration, many more Group-led studies have been "endorsed" by other Groups such that most phase 3 studies are now Intergroup efforts both in terms of scientific leadership and accrual.

The steady increase in accruals is, in part, a function of the large variety of studies available on the CTSU menu (Figure 13). 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. There are currently 58 trials on the CTSU menu, with 28 more in development. In addition to Group-led studies, the menu now also contains phase 3 trials led by International study groups, CCOP research bases, and some phase 2 studies in uncommon cancers. It is anticipated that eventually all phase 3 CTEP-sponsored studies will be available through the CTSU.

A unique aspect of the CTSU is its extensive use of the Internet. It has both a public web site9 and a limited access, password protected members' web site10. All CTSU members have access to protocols, protocol-specific forms (e.g., case report forms, materials ordering forms) and patient educational materials on the members' web site. Protocol-specific materials that are provided on-line include the following: completed IRB submission applications, audit worksheets, protocol-specific time and events schedules, and pocket-sized protocol cards that outline protocol-specific eligibility requirements and treatment plans.

To assure that investigators would not be overly burdened by the requirements of participating in clinical trials led by different organizations, the CTSU consolidated regulatory processes (site and investigator credentialing, specific protocol requirements and IRB approvals). All adult Cooperative Group regulatory submissions, with the exception of some of the major phase 3 prevention trials, are now submitted to a single CTSU regulatory office. The CTSU and the Adult Cooperative Groups have collaborated to develop a web-based Regulatory Support System (RSS), capable of housing all Adult Cooperative Groups' regulatory documents in centralized repository. This consolidation has streamlined the regulatory process for investigators at local sites who can now submit their credentials once each year including a 1572 form for investigational drugs and a supplemental group membership form that are made available to all relevant Groups via RSS.

Cooperative Group trials supported by the CTSU are steadily migrating to electronic data capture from local sites, rather than the traditional paper-or fax- based approaches that have predominated previously. The CTSU is helping to standardize web-based data entry by utilizing an Oracle toolset that is potentially scalable across the country. Currently, a large pilot effort is underway to utilize this electronic data capture tool. Lessons learned during this pilot experience should enable NCI to rapidly move towards offering a national system for electronic data capture on multi-center studies. A single electronic data capture system will streamline training of research personnel and should further facilitate cross-group enrollments.

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