Grant Number:	5U01CA269195-05 Interpret this number
Primary Investigator:	Lieberman, Marya
Organization:	University Of Notre Dame
Project Title:	Adapting a Point of Use Test Card, the Chemopad, for Protecting Chemotherapy Drug Quality in Sub-Saharan Africa
Fiscal Year:	2026

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. There is currently no commercial technology to screen for bad quality chemotherapy products at the point of use, and drug regulators in many countries do not conduct post-market surveillance testing on chemotherapy products. Bad quality chemotherapy medicines enter the US through smuggling and gray market supply chains, but their prevalence and impact on patient outcomes is unknown. This project will directly benefit patients in the United States by protecting them from bad quality anticancer products. It is easier and cheaper to access bad quality anticancer products in LMICs than in the US, so by including a foreign implementation site, we can validate the chemoPAD technology more quickly and at lower cost, after which it can be deployed in the US. 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. Partners in Ethiopia, Malawi, Cameroon, and Kenya, where quality problems are more prevalent, 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. The US gray market will also be probed through test buys and analysis of any products we are able to obtain. After a technical performance milestone is passed, we will tailor the clinical validation of SpotCheck to suit each site. The validation of the SpotCheck system will proceed through a planning and ethical approval milestone 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 and develop commercialization pathways in the US. Impact: This project will help to fill the huge evidence gaps about the quality of chemo drugs in LMICs and in the US gray market, make it harder for manufacturers and distributors to sell bad quality products, and improve the quality of chemotherapy products in the US and all over the world.




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EPub date: 2026-02-04 00:00:00.0.
PMID: 41637673
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