Adapting a point of use test card, the chemoPAD, for protecting chemotherapy drug quality in sub-Saharan Africa

适配使用点测试卡，chemoPAD，用于保护 撒哈拉以南非洲化疗药物质量 项目概要/摘要 目标：验证一种新技术，用于在使用时检测质量差的化疗产品。 动机：化疗药物是中低收入国家负担得起的癌症治疗的支柱， 收入国家（LMIC），但LMIC往往缺乏技术和监管能力，以评估质量， 化疗产品。目前还没有商业化的技术来筛查质量不好的化疗药物 产品在LMIC环境中的使用点，以及埃塞俄比亚，马拉维，肯尼亚和 喀麦隆不对化疗产品进行上市后监督检测。 活动：将被验证的技术，称为SpotCheck，由一个便宜的纸测试组成。 卡（chemoPAD）和手机应用程序。我们将首先调整chemoPAD筛选八种类型的 注射化疗药物。手机应用程序的神经网络将被训练来识别产品， 伪造或含有低于所述API含量的65%。临床、学术和供应链合作伙伴， 埃塞俄比亚、马拉维、喀麦隆和肯尼亚将对320个国家进行年度情况意识和质量调查， 研究结果将使一组美国的研究人员能够在2010年获得一个新的化疗产品。北卡罗来纳州来当模特 化疗产品的市场，并评估SpotCheck系统的成本效益。后 如果通过了技术性能里程碑，我们将定制SpotCheck的临床验证，以适应当地 每个研究中心的需求、临床工作流程和监管能力。SpotCheck系统的验证将 通过规划和伦理审批里程碑（埃塞俄比亚和马拉维的Y3，肯尼亚的Y 4， 喀麦隆）和三个临床阶段：能力研究，临床验证和实施试点。 熟练度测试将证明肿瘤药剂师和护士可以准确使用SpotCheck >85%检测SF产品。临床确认将确定SpotCheck在临床试验中是否正确工作。 设置在真实的产品上，而不是熟练度样本上。实施试点研究将探讨 SpotCheck能够测试在准备患者治疗后产品小瓶中剩余的液滴， 这种使用方法将允许在许多医院可持续地实施SpotCheck， 在低资源环境下的诊所。技术转让工作将使LMIC合作伙伴能够生产 chemoPAD本地化，并将手机应用程序集成到监管报告系统中。 影响：该项目将有助于填补有关LMIC化疗药物质量的巨大证据缺口，使其 制造商和分销商更难销售质量差的产品，并提高产品的质量， 用于治疗中低收入国家的患者。 1

Adapting a point of use test card, the chemoPAD, for protecting chemotherapy drug quality in sub-Saharan Africa Project Summary/Abstract Goal: validate a new technology for detecting bad quality chemotherapy products at the point of use. Motivation: Chemotherapy medicines form the backbone of affordable cancer treatment in low- and middle- income countries (LMICs), yet LMICs often lack technical and regulatory capacity to evaluate the quality of chemotherapy products. There is currently no commercial technology to screen for bad quality chemotherapy products at the point of use in LMIC settings, and the drug regulators in Ethiopia, Malawi, Kenya, and Cameroon do not conduct post-market surveillance testing on chemotherapy products. Activities: The technology that will be validated, called SpotCheck, consists of an inexpensive paper test card (the chemoPAD) and a cell phone app. We will first adapt the chemoPAD to screen eight types of injectable chemotherapy drugs. The phone app’s neural network will be trained to identify products that are falsified or contain less than 65% of the stated API content. Clinical, academic, and supply chain partners in Ethiopia, Malawi, Cameroon, and Kenya will conduct annual situation awareness and quality surveys of 320 chemotherapy products per year; the results will enable a team of researchers at U. North Carolina to model the markets for chemotherapy products and evaluate the cost-effectiveness of the SpotCheck system. After a technical performance milestone is passed, we will tailor the clinical validation of SpotCheck to suit the local needs, clinical workflows, and regulatory capacity in each site. The validation of the SpotCheck system will proceed through a planning and ethical approval milestone (Y3 in Ethiopia and Malawi and Y4 in Kenya and Cameroon) and three clinical phases: proficiency study, clinical validation, and implementation pilot. Proficiency testing will demonstrate that oncology pharmacists and nurses can use SpotCheck with accuracy >85% to detect SF products. Clinical validation will establish whether SpotCheck works correctly in a clinical setting on authentic products, rather than proficiency samples. The implementation pilot study will probe SpotCheck’s ability to test the drops left over in product vials after patient treatments are prepared in the hospital; this method of use would allow sustainable implementation of SpotCheck in many hospitals and clinics in low-resource settings. Technology transfer efforts will empower LMIC partners to produce the chemoPAD locally and integrate the cell phone app into regulatory reporting systems. Impact: This project will help to fill the huge evidence gap about the quality of chemo drugs in LMICs, make it harder for manufacturers and distributors to sell bad quality products, and improve the quality of products that are used to treat patients in LMICs. 1