The OLACPD was launched in 2008 to advance the mission of NCI by collaborating with government agencies, researchers, and organizations to further cancer research in Latin American countries. Under the leadership of Jorge Gomez, M.D., Ph.D., OLACPD has developed a strategic research plan for Latin America to increase capability of these countries to participate and partner in cancer research through development of needed clinical trials networks, the enhancement of advanced technology centers, and development of multinational and multidisciplinary training programs. The proposed plan intends to continue funding of the breast cancer pilot study based on the model presented in the OLACPD Strategic Plan for Latin America and addressed in the implementation plan described below. Implementation Plan for funding the Breast Cancer Pilot Study by OLACPD and five Latin American countries (Argentina, Brazil, Chile, Mexico, and Uruguay): In coordination with SAIC-Frederick, OLACPD has developed a business model that adheres to the following principles: 1. Utilizing the contract mechanism. This mechanism was selected to minimize potential risks to the NCI and to provide the means to assess progress and confer project management responsibility of the pilot study. a. Based on SOW developed by OLACPD and SAIC, contractual agreements have been issued for the first year and renew on a yearly basis (based on progress report). b. Payments will be released every six months allowing NCI and contracting officers to evaluate progress and performance on a regular basis;and, identify under-performers. Should the latter condition exist, stop payment action will occur if necessary. 2. Appropriate utilization of funds. The contracting officers at SAIC-Frederick have excellent experience in oversight and reviewing accounting practices in the international setting. a. An appropriate accounting and reporting system is in place by SAIC contracting office to maintain and confirm the appropriate utilization of funds. 3. Adherence to Statement of Work (SOW). The SOW customized for each country incorporates the terms and conditions agreed upon and consented for the conduct of the breast cancer pilot study. a. NCI and its contractors (SAIC and CCSA acting as the CRO) will continue to closely monitor progress of the project, including adherence to protocol, accrual, quality control and assurance, as well as auditing of the sites when necessary. i. SAIC-Frederick is responsible to the NCI for establishing and maintaining the contracts for OLACPD, notification of deliverables, providing project management, and, reporting and invoicing of the US-LACRN business activities under this clinical protocol. ii. CCSA is responsible for carrying out scientific management and programmatic aspects for the NCI. 4. Adherence to the Office of Human Research Protections. The breast cancer pilot study is supported by the NCI and as such, the US-LACRN must ensure compliance to the rules and regulations including Federal Wide Assurances, constitution of IRBs (or Ethics Committees), and other activities. a. An independent Data Safety and Monitoring Committee (DSMC) is being formed to ensure the quality of the data, and safeguard the protection of human subjects participating in research. The NCI will be represented on this committee. 5. Clinical Study Progress Appraisal. An evaluation process will be developed in order to assess progress at the institutional level in each country taking into consideration the scientific goals and the operational implementation of the pilot study.
