National Cancer Institute, Acquisition Management Branch, TBS, 6120 Executive Blvd, EPS/Rm 603 Bethesda, MD 20892-7220

R -- CANCER TRIALS SUPPORT UNIT (CTSU) SOL N02-CM-97024-26 DUE 042899 POC Carolyn L. Swift (301) 435-3819 WEB: National Cancer Institute's Research Contracts and, http://amb.nci.nih.gov/. E-MAIL: Carolyn Swift, Contracting Officer, cs102w@nih.gov. 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, gastro-intestinal 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 adultCooperative 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 (1) cost-reimbursement, completion contract will be awarded on an incrementally funded basis for a period of five (5) 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 may be accessed through the Research Contracts and Acquisition Branch homepage by using the following internet address -- http://amb.nci.nih.gov/ . 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. Posted 02/11/99 (W-SN297718). (0042)

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