Latin American Breast Cancer Pilot

OLACPD成立于2008年，旨在通过与政府机构、研究人员和组织合作，推动NCI的使命，在拉丁美洲国家进一步开展癌症研究。在豪尔赫·戈麦斯医学博士的领导下，OLACPD为拉丁美洲制定了一项战略研究计划，通过发展所需的临床试验网络、加强先进技术中心以及发展多国和多学科培训计划，提高这些国家参与和合作癌症研究的能力。 拟议计划打算根据《拉丁美洲和加勒比办事处拉丁美洲战略计划》提出并在下文所述执行计划中述及的模式，继续为乳腺癌试点研究提供资金。 OLACPD和五个拉丁美洲国家(阿根廷、巴西、智利、墨西哥和乌拉圭)资助乳腺癌试点研究的执行计划：在与SAIC-Frederick的协调下，OLACPD制定了遵循以下原则的商业模式： 1.运用契约机制。选择这一机制是为了最大限度地减少对NCI的潜在风险，并为评估进展情况和赋予试点研究的项目管理责任提供手段。 A.根据OLACPD和SAIC制定的SOW，已经发布了第一年的合同协议，并每年续签(基于进度报告)。 B.付款将每六个月发布一次，允许NCI和合同官员定期评估进展和业绩；并确定表现不佳的人员。如果存在后一种情况，则将在必要时执行停止付款操作。 2.合理使用资金。SAIC-Frederick的合同官员在监督和审查国际环境下的会计做法方面拥有丰富的经验。 A.国家工商行政管理总局承包处建立了适当的会计和报告制度，以维持和确认资金的适当使用。 3.遵守工作说明书(SOW)。为每个国家定制的SOW包含了为进行乳腺癌试点研究而商定和同意的条款和条件。 A.NCI及其承包商(SAIC和CCSA作为CRO)将继续密切监测项目的进展，包括遵守协议、应计、质量控制和保证，以及在必要时对工地进行审计。 I.SAIC-Frederick对NCI负责建立和维护OLACPD合同、交付成果通知、提供项目管理，以及根据本临床协议报告和开具US-LACRN业务活动的发票。 二、CCSA负责NCI的科学管理和规划方面的工作。 4.遵守人类研究保护办公室的规定。乳腺癌试点研究得到了NCI的支持，因此，US-LACRN必须确保遵守规则和条例，包括联邦范围的保证、IRBs(或道德委员会)的组成和其他活动。 A.正在成立一个独立的数据安全和监测委员会(数据安全和监测委员会)，以确保数据的质量，并保护参与研究的人类对象。NCI将在这个委员会中派代表参加。 5.临床研究进展评价。将制定一个评价程序，以评估每个国家在机构一级取得的进展，同时考虑到试点研究的科学目标和业务执行情况。

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.