Eligibility criteria for cancer drug trials in adult patients: Evidence from China, 2013-2021.
Eligibility criteria used in cancer clinical trials ensure internal validity but may restrict enrollment and limit external generalizability. The US National Cancer Institute (NCI) has recommended broader criteria, but similar guidance is lacking in China.
The authors reviewed cancer clinical trials registered on China's National Medical Products Administration (NMPA) Registration and Information Disclosure Platform between 2013 and 2021. Eligibility criteria were classified as compliant or restrictive based on the US NCI recommendations. Trends over time and associations between trial characteristics and noncompliance were analyzed.
There were 2448 cancer clinical trials investigating anticancer drugs registered in China. Eligibility criteria for performance status (PS), organ function, and comorbidities were used in 96.3%, 74.7%, and 95.3% of trials, respectively; overall, 97.0% used at least one restrictive criterion beyond NCI's recommendations. The median number of restrictive criteria used was two (interquartile range [IQR], 1-3) for trials approved in 2013-2015, three (IQR, 2-4) for trials approved in 2016-2018, and three (IQR, 2-4) for trials approved in 2019-2021 (p < .001). Noncompliance became more frequent for PS (p = .000), cardiac function (p = .005), and prior/concurrent malignancies (p = .018) over time.
These findings highlight a need for more inclusive and modernized eligibility criteria for the advancement of cancer clinical trials in China.
The authors reviewed cancer clinical trials registered on China's National Medical Products Administration (NMPA) Registration and Information Disclosure Platform between 2013 and 2021. Eligibility criteria were classified as compliant or restrictive based on the US NCI recommendations. Trends over time and associations between trial characteristics and noncompliance were analyzed.
There were 2448 cancer clinical trials investigating anticancer drugs registered in China. Eligibility criteria for performance status (PS), organ function, and comorbidities were used in 96.3%, 74.7%, and 95.3% of trials, respectively; overall, 97.0% used at least one restrictive criterion beyond NCI's recommendations. The median number of restrictive criteria used was two (interquartile range [IQR], 1-3) for trials approved in 2013-2015, three (IQR, 2-4) for trials approved in 2016-2018, and three (IQR, 2-4) for trials approved in 2019-2021 (p < .001). Noncompliance became more frequent for PS (p = .000), cardiac function (p = .005), and prior/concurrent malignancies (p = .018) over time.
These findings highlight a need for more inclusive and modernized eligibility criteria for the advancement of cancer clinical trials in China.
Authors
Ma Ma, Zhang Zhang, Chen Chen, Fu Fu, Han Han, Zhang Zhang, Ross Ross, Shi Shi, An An, Guan Guan
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