The Cancer Trials Support Unit (CTSU) is a pilot program sponsored by the National Cancer Institute (NCI). The CTSU has two primary functions. It centralizes regulatory support for all adult Cooperative Group trials (phases I- III), thereby reducing duplication among Group members regarding credentialing, compliance with federal regulations, and institutional review board (IRB) activities. It also provides all Group members and select non-Group members with access to phase III treatment trials.
There are currently 28 active CTSU-designated trials in the following tumor types: breast, gastrointestinal, genitourinary, adult leukemia, lung, and myeloma. The list is expanding to include other diseases such as melanoma, ovarian cancer, and sarcoma. Physicians registered with the CTSU can enroll patients in these trials even if they are not members of the Cooperative Group that is leading the trial. The CTSU will potentially allow new treatments to be available to more patients, regardless of their geographic location, because many more oncologists will now have access to these trials.
Although originally a venue for oncologists who belonged to the adult Cooperative Groups,[1] the CTSU has recently expanded to include oncologists who are not members of the Cooperative Groups. A physician in the United States who is interested in becoming a CTSU-credentialed investigator and is not a member of a Cooperative Group should complete an online Interest Form (www.ctsu.org/int_member_ form.asp). A postcard version of the Interest Form can be obtained from the CTSU Help Desk by calling (888) 823-5923. However, before physicians not associated with NCI’s Cooperative Group program can enroll patients in clinical trials, they must meet standards similar to those of Cooperative Group members (ie, credentials must be verified, site preparedness must be assessed). Non-Group members interested in trials available via the CTSU can find out how to become CTSU members by visiting the CTSU website (www.ctsu.org).
Registration With the CTSU
Registration with the CTSU allows unrestricted access to a broad menu of NCI-sponsored adult phase III Cooperative Group protocols outside of the registrant’s respective Cooperative Group. Members can receive financial reimbursement or funding credit for each patient enrolled, and credit towards Cooperative Group membership accrual requirements even when the registrant’s respective Cooperative Group does not sponsor the protocol.
Canadian investigators affiliated with a Cooperative Group who are interested in participating in CTSU trials need to register with the CTSU. Once Canadian regulatory approval of the study has been obtained, notification of this will be posted on the CTSU registered member website. At that time, the CTSU will provide a French translation of the consent and post it along with the Investigator Agreement, Qualified Investigator Undertaking, Clinical Trials Site Information, and Research Ethics Board Attestation forms on the protocol-specific page of the CTSU registered member website. For all Canadian sites, the trial may not be locally activated until required ethics and regulatory documents are completed and forwarded to the CTSU.
Conclusion
The CTSU serves as a cornerstone in the NCI’s ongoing effort to restructure its clinical treatment trials program to better serve clinical investigators in the field and their patients. By providing technical and administrative support to complement the top quality, peer-reviewed research efforts of NCI’s Clinical Trials Cooperative Groups, the CTSU is designed to help make the overall system more flexible, efficient, and cost-conscious for physicians. Doing so should assure that the NCI achieves its ultimate goal of providing new and innovative cancer treatments to more patients via carefully conducted clinical trials.
Upcoming CTSU Events
The CTSU will be present at the following upcoming conferences:
- Society of Clinical Research Associates (SOCRA): September 19-22, 2002, Philadelphia, Pa
- North Central Cancer Treatment Group (NCCTG): October 8-11, 2002, Rochester, Minn
- Southwest Oncology Group (SWOG): October 23-27, 2002, San Antonio, Tex
- Cancer and Leukemia Group B (CALGB): November 7-10, 2002, Tampa, Fla
- Eastern Cooperative Oncology Group (ECOG): November 16-18, 2002, Miami, Fla
CTSU Contact Information
General questions regarding the CTSU may be submitted online to ctsucontact@westat.com. The General Information number, (888) 823-5923, will handle general inquiries about the CTSU, including information about clinical studies, investigator registration, and other issues. The Patient Registrar number, (888) 462-3009, is specifically for patient enrollment and adverse event reporting.
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