Latin American Breast Cancer Pilot

拉丁美洲乳腺癌试点

• 批准号: 8654819
• 负责人: DAVID HEIMBROOK
• 金额: $ 307.5万
• 依托单位: LEIDOS BIOMEDICAL RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-26 至 2018-09-25
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8654819
• 关键词: Accounting; Address; Adherence; Advanced Technology Center; Agreement; American; Argentina; Brazil; Businesses; Chile; Clinical; Clinical Protocols; Clinical Research; Clinical Trials Network; Collaborations; Consent; Constitution; Contractor; Contracts; Country; Data; Data Quality; Development; Doctor of Medicine; Doctor of Philosophy; Ensure; Ethics Committees; Evaluation; Funding; Goals; Government Agencies; Institutional Review Boards; International; Latin America; Leadership; Mexico; Mission; Modeling; Monitor; Notification; Office for Human Research Protections; Performance; Pilot Projects; Process; Progress Reports; Protocols documentation; Quality Control; Regulation; Report (account); Reporting; Research; Research Personnel; Risk; Safety; Science; Site; Strategic Planning; System; Training Programs; Uruguay; Work; anticancer research; base; evidence base; experience; human subject protection; malignant breast neoplasm; multidisciplinary; payment; quality assurance

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.

OLACPD成立于2008年，旨在通过与政府机构、研究人员和组织合作，推进NCI的使命，以促进拉丁美洲国家的癌症研究。在豪尔赫·戈麦斯医学博士的领导下，哲学博士、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，以及制定多国和多学科培训计划，提高这些国家参与和合作进行癌症研究的能力。 拟议的计划打算继续根据拉丁美洲和加勒比人口与发展组织拉丁美洲战略计划中提出的模式为乳腺癌试点研究提供资金，并在下文所述的执行计划中加以处理。 拉丁美洲和加勒比残疾人组织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实施计划：拉丁美洲和加勒比残疾人组织与SAIC-Frederick合作，制定了一个商业模式，该模式坚持以下原则： 1.利用合同机制。选择该机制是为了最大限度地减少NCI的潜在风险，并提供评估进展的方法并赋予试点研究的项目管理责任。 a.根据拉加人口与发展办公室和国家工商行政管理局制定的工作说明书，第一年的合同协议已经发布，并每年更新（根据进度报告）。 B.付款将每六个月发放一次，使NCI和合同官员能够定期评估进展和业绩;并确定业绩不佳者。如果存在后一种情况，必要时将采取停止付款行动。 2.合理使用资金。SAIC-Frederick的签约人员在国际环境下监督和审查会计做法方面拥有丰富的经验。 a. SAIC合同办公室建立了适当的会计和报告系统，以维护和确认资金的适当使用。 3.遵守工作说明书（SOW）。为每个国家定制的工作说明书包含为开展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，包括遵守方案、应计费用、质量控制和保证，以及必要时对研究中心进行稽查。 I. SAIC-Frederick向NCI负责建立和维护OLACPD合同、可交付成果通知、提供项目管理以及本临床方案下US-LACRN业务活动的报告和发票。 二. CCSA负责对NCI进行科学管理和计划方面的工作。 4.遵守人类研究保护办公室。乳腺癌初探性研究由NCI支持，因此，US-LACRN必须确保遵守规则和法规，包括联邦大范围审查、IRB（或伦理委员会）的组成和其他活动。 a.正在组建一个独立的数据安全和监测委员会（DSMC），以确保数据的质量，并保护参与研究的人类受试者。国家癌症研究所将派代表参加该委员会。 5.临床研究进展评估。将制定一个评价程序，以便在考虑到试点研究的科学目标和实际执行情况的情况下，评估每个国家在体制一级取得的进展。