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: 10416695
• 负责人: Marya Lieberman
• 金额: $ 48.59万
• 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/10416695
• 关键词: Address; Africa South of the Sahara; Awareness; Biological Assay; Cameroon; Cancer Etiology; Clinic; Clinical; Clinics and Hospitals; Cold Chains; Country; Custom; Data; Development Plans; Drops; Drug Screening; Educational workshop; Ethics; Ethiopia; Goals; Gold; Health; High Pressure Liquid Chromatography; Hospitals; Image; Injectable; Kenya; Left; Malawi; Malignant Neoplasms; Manufacturer Name; Medicine; Methods; Modeling; Motivation; Needs Assessment; North Carolina; Nurses; Oncology; Outcome; 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; Ships; Site; Surveys; System; Technology; Technology Transfer; Telephone; Testing; Training; Validation; Vertebral column; Vial device; Work; cancer therapy; chemotherapy; cost-effectiveness evaluation; drug quality; improved; low and middle-income countries; multidisciplinary; neural network; new technology; outreach; post-market; programs; screening; smartphone Application; symposium; 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

调整使用点测试卡Chemopad，以保护 撒哈拉以南非洲的化学疗法药物质量 项目摘要/摘要 目标：验证一种新技术，用于在使用时检测不良质量化疗产品。 动机：化学疗法药物构成低和中间的负担得起的癌症治疗的骨干 收入国家（LMIC），但LMIC通常缺乏评估质量的技术和监管能力 化学疗法产品。目前没有商业技术可以筛选质量不佳的化学疗法 在LMIC环境中使用的产品，以及埃塞俄比亚，马拉维，肯尼亚和 喀麦隆不对化学疗法产品进行市场后监视测试。 活动：将被验证的技术称为Spotcheck，由廉价的纸质测试组成 卡（Chemopad）和手机应用程序。我们将首先适应化学杂志以筛选八种类型的 可注射的化学疗法药物。电话应用程序的神经网络将经过培训，以识别 伪造或包含少于陈述的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，喀麦隆和肯尼亚将进行年度情况认识和质量调查320 每年化学疗法产品；结果将使美国北卡罗来纳州的一组研究人员能够建模 化学疗法产品的市场并评估点检查系统的成本效益。之后 通过技术性能里程碑，我们将定制Spotcheck的临床验证以适合当地 每个站点的需求，临床工作流程和监管能力。验证系统的验证将 通过规划和道德批准里程碑进行（埃塞俄比亚的Y3，马拉维和Y4在肯尼亚以及 喀麦隆）和三个临床阶段：熟练度研究，临床验证和实施试验。 熟练度测试将表明肿瘤学药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在临床上是否正常工作 设置正宗产品，而不是熟练样品。实施试点研究将证明 SpotCheck在准备患者治疗后，在产品小瓶中剩下的滴剂的能力 医院;这种使用方法将允许在许多医院进行可持续实施Spotcheck，以及 低资源环境中的诊所。技术转移工作将使LMIC合作伙伴能够生产 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有关LMICS化学药物质量的巨大证据差距，使其成为 制造商和分销商更难销售质量不佳的产品，并提高产品的质量 用于治疗LMIC的患者。 1