Release Date:  February 19, 1999

RFP AVAILABLE:  N02-CM-97024-26


National Cancer Institute

To facilitate access by investigators to a broader menu of Cooperative Group
clinical trials, to centralize and make more efficient a number of
administrative tasks common to all the Cooperative Groups, and to relieve
participating institutions of the burden of multiple clinical trials audits,
the Cancer Therapy Evaluation Program (CTEP) of the Division of Cancer
Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) is seeking a
Contractor to implement and manage a Cancer Trials Support Unit (CTSU) to
coordinate selected cancer treatment trials.  This CTSU will have several key
functions: 1) development and operation of a comprehensive system for clinical
trials management; 2) development of a regulatory support system; 3)
development of a clinical trials informatics support system; 4) development
and operation of a protocol access and referral system; 5) development and
conduct of education and training in the CTSU system; and 6) development,
operation and maintenance of a financial management system for distribution of
per patient payments and leadership funds.  The menu of treatment studies for
the accrual and trial data management part of this  project will be limited to
tumors of the lung, genito-urinary system, breast, gastrointestinal tract as
well as adult leukemia (acute and chronic).  A subset of open Phase 3 studies
(adjuvant and metastatic trials) in these tumor types within the Cooperative
Groups will be "grandfathered" into the system to provide a menu of protocols
to begin operations. The specific studies to be opened will be negotiated
between CTEP, the Cooperative Groups and the CTSU since it will depend on the
status of particular studies (accrual and projected closure) at the time the
CTSU is able to begin accepting registrations. Other mitigating factors will
have to be considered when selecting the initial studies for the CTSU
(industrial sponsor agreements, technical expertise required, etc.).  It is
anticipated that the initial menu will consist of 15-20 protocols.  After
development of an initial menu through this "grandfathering process", it is
anticipated that approximately six new trials may enter the menu in Year 1,
with twelve new trials per year in Years 2-5.  With new trials opening and
older ones concluding accrual, it is reasonable to assume a potential menu
size of 50 or more open Phase 3 protocols at any one time, although the
follow-up burden will likely number close to one hundred protocols over the
duration of this contract.  A major goal of the project is to directly
reimburse investigators in the field for their research efforts.  This
reimbursement shall be awarded on a per-patient basis.  The CTSU shall be
responsible for distributing these funds which will be provided to the CTSU on
an annual basis by the NCI.  There are likely to be over 750 or more sites
participating in this part of the project (by Year 3) for which subcontracts
will have to be negotiated.  In Year 1, it is anticipated that 675 patients
will be accrued, Year 2-1,550 patients, Year 3-2,800 patients, Year 4-3,400
patients and Year 5-4,000 patients.  When new studies are approved for the
Network menu, the CTSU shall also distribute "leadership" funds to the
Protocol Chair (salary support), the Statistical Office (for salary support of
the study statistician and data managers), and to the Operations Office (for
protocol development).  These funds are provided in order that the study
sponsor has sufficient manpower and dedicated time to rapidly assemble the
protocol and to direct the study.  Included in the RFP as an optional task is
the requirement that the CTSU  have the capability to sponsor, file and manage
Investigational New Drug Applications (INDs) for agents used in trials
included in the Network menu.  The CTSU shall serve as the interface between
the statistical centers and investigators in the national Network for all
protocols included in the Network menu. It is important to note however that
analysis of all study data collected via the CTSU will remain the
responsibility of the study leaders (Cooperative Groups or others), not the
CTSU, and the study leaders will provide the ultimate repository for all study
data. The CTSU's tasks are therefore supportive in nature, and will require a
close working relationship with all study leaders and their Statistical and
Data Management Centers.  Other parts of this project shall serve to help NCI
transition its adult Cooperative Groups towards a more efficient, electronic-
based system for clinical trials management. This part of the project will
interface with all NCI's adult Cooperative Groups and their respective
clinical trials, numbering about 350 active protocols at any time. NCI is
currently coordinating development of an informatics system for clinical
trials, in collaboration with the Cooperative Groups, Cancer Centers and
Industry, that takes advantage of contemporary technical advances in the way
clinical data is acquired, transmitted, and processed. The project termed the
Clinical Trials Enterprise System (CTES) has already begun to develop new
tools for trials management. The CTSU shall use CTES data and process models,
maintained in Oracle's Designer 2000 tool, in the development of informatics
tools to accomplish many of the tasks required of the CTSU. Capability and
experience with Oracle design tools is required. The CTSU shall collaborate
actively with NCI designated contractors who are developing and implementing
components of the CTES.  Included as tasks the CTSU shall perform that pertain
to all adult Cooperative Groups and Network members are : 1) Development of an
Institutional Review Board (IRB) approval data base for all Cooperative Group
and Network studies and a credentialing data base for all Cooperative Group
and Network members; 2) Operation and maintenance of a referral service for
all Cooperative Group and Network trials that shall enable referring
physicians and patients to link appropriate trials to participating physicians
closest to the patient and; 3) Development and oversight of a system for
conducting a single site audit of all adult Cooperative Group and Network
protocols, even if the site participates in several different Cooperative
Group trials.  There are about 8000 active members participating in
Cooperative Group trials,  representing nearly 1500 institutions/sites.
Approximately 20,000 patients are enrolled annually on Cooperative Group
treatment studies (Phase 1-3) with 12,000 of these also enrolled on ancillary
laboratory or companion studies.

The Government anticipates that one cost-reimbursement, completion contract
will be awarded on an incrementally funded basis for a period of five years. 
SIC Code for this acquisition is 8741.  The solicitation is scheduled for
electronic release on or about February 26, 1999.  There will be a preproposal
conference in Bethesda, MD on March 22, 1999.  Details on submission of
questions prior to the conference and logistical details about the conference
will be in the solicitation or e-mail the Contracting Officer.  The RFP will
be available on the Research Contracts and Acquisition Branch homepage at the
following internet address:  It is the offeror's
responsibility to monitor the above internet site for the release of this
solicitation and any amendments.  Potential offerors will be responsible for
downloading their own copy of the solicitation and amendments.  No collect
calls will be accepted.


Inquiries may be direct to:

Carolyn L. Swift
Research Contracts and Acquisition Branch
National Cancer Institute
6120 Executive Boulevard, Room 603 MSC 7220
Bethesda, MD  20892-7220
Telephone:  (301) 435-3819
FAX:  (301) 402-6699

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