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, 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.
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
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,
- 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,
CTSU Contact Information
General questions regarding the CTSU may be submitted online to email@example.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.
1. Michaels M, Denicoff AM, Bright MA, et al: Current initiatives at the
National Cancer Institute. Oncology Issues 17:33-35, 2002.