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

采用使用点测试卡 chemoPAD 来保护撒哈拉以南非洲地区的化疗药物质量

• 批准号: 10689048
• 负责人: Marya Lieberman
• 金额: $ 46.15万
• 依托单位: UNIVERSITY OF NOTRE DAME
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-23 至 2027-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10689048
• 关键词: Address; Africa South of the Sahara; Awareness; Biological Assay; Cameroon; Cancer Etiology; Clinic; Clinical; Clinics and Hospitals; Cold Chains; Country; Data; Development Plans; Drops; Drug Screening; Educational workshop; Ethics; Ethiopia; Goals; Health; High Pressure Liquid Chromatography; Hospitals; Image; Injectable; Kenya; Left; Malawi; Malignant Neoplasms; Manufacturer; Marketing; Medicine; Methods; Modeling; Motivation; Needs Assessment; North Carolina; Nurses; Oncology; Paper; Participant; Patients; Performance; Pharmaceutical Preparations; Pharmacists; Pharmacologic Substance; Phase; Pilot Projects; Play; Privatization; Protocols documentation; Reporting; Research Personnel; Resource-limited setting; Resources; Sampling; Scientist; Screening Result; Site; Surveys; System; Technology; Technology Transfer; Telephone; Testing; Training; Validation; Vertebral column; Vial device; Work; cancer therapy; chemotherapy; cost-effectiveness evaluation; drug quality; empowerment; improved; low and middle-income countries; manufacture; multidisciplinary; neural network; new technology; outreach; post-market; programs; screening; smartphone application; supply chain; symposium; therapy outcome; validation studies

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

采用使用点测试卡 chemoPAD 来保护 撒哈拉以南非洲地区的化疗药物质量 项目概要/摘要 目标：验证一种在使用时检测劣质化疗产品的新技术。 动机：化疗药物构成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 往往缺乏评估其质量的技术和监管能力 目前还没有商业技术来筛查劣质化疗产品。 中低收入国家环境中的产品使用点以及埃塞俄比亚、马拉维、肯尼亚和其他国家的药品监管机构 喀麦隆不对化疗产品进行上市后监测测试。 活动：将要验证的技术称为 SpotCheck，由一种廉价的纸质测试组成 我们将首先调整 chemoPAD 以筛查八种类型。 手机应用程序的神经网络将被训练来识别可注射的化疗药物。 临床、学术和供应链合作伙伴中伪造或包含低于 65% 的规定 API 内容。 埃塞俄比亚、马拉维、喀麦隆和肯尼亚将对 320 个国家进行年度态势感知和质量调查 每年的化疗产品；研究结果将使北卡罗来纳州的一组研究人员能够建立模型 化疗产品市场并评估 SpotCheck 系统的成本效益。 技术性能里程碑已通过，我们将根据当地情况定制 SpotCheck 的临床验证 SpotCheck 系统的验证将满足每个站点的需求、临床工作流程和监管能力。 继续完成规划和道德批准里程碑（埃塞俄比亚和马拉维为 Y3，肯尼亚为 Y4， 喀麦隆）和三个临床阶段：能力研究、临床验证和实施试点。 能力验证将证明肿瘤药剂师和护士可以准确地使用 SpotCheck >85% 检测 SF 产品。临床验证将确定 SpotCheck 在临床中是否正常工作。 实施试点研究将探讨真实产品而不是能力验证样本。 SpotCheck 能够测试患者治疗准备完毕后产品瓶中剩余的药滴 医院；这种使用方法将允许在许多医院和地区可持续实施 SpotCheck 技术转让工作将使中低收入国家合作伙伴能够生产出资源匮乏的诊所。 chemoPAD 在本地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中低收入国家化疗药物质量方面的巨大证据空白，使其 制造商和经销商更难销售劣质产品，并提高劣质产品的质量 用于治疗中低收入国家的患者。 1