Strategies for Expediting Clinical Trials in the Next Public Health Emergency

Abstract

This Viewpoint highlights areas for improving implementation of future epidemic clinical trials, focusing on research among nonhospitalized persons.

Association of Tecovirimat Therapy With Mpox Symptom Improvement: A Cross-sectional Study—King County, Washington, May–October 2022

“…Given the potential benefit of early treatment in severe disease, providers could consider offering tecovirimat prior to laboratory confirmation, particularly as data suggest that well-trained sexual health clinic providers can accurately diagnose mpox prior to laboratory confirmation [ 31 ]. However, treatment decisions should be integrated with the need for more rigorous data on tecovirimat treatment effectiveness, and patients should be given the opportunity to participate in RCTs as part of the treatment discussion [ 6 ].…”

“…Global access to tecovirimat remains challenging [ 6 , 7 ], and there are persistent disparities in mpox acquisition and access to care among racial and ethnic minority and gender minority groups [ 1 , 35 ]. Prior analyses on tecovirimat prescriptions in King County did not detect any differences in tecovirimat receipt by race or ethnicity [ 20 ].…”

“…These results likely reflect model overfitting from small sample sizes or true variations in mpox-focused care by race, ethnicity, and gender. While the generalizability of our findings is unclear, public health responses should continue to optimize access to care and address disparities among high-risk groups [ 6 , 7 , 36 ].…”

“…During the 2022 outbreak, constrained access to tecovirimat including challenges with equitable distribution [ 5 , 6 ] and differences in prescribing practices, and the rapid decrease of MPXV infections in the US and internationally hindered assessment of tecovirimat's effectiveness in real-world settings. Mpox research was poorly funded prior to 2022 despite the burden of disease in endemic areas, and thus data from prospective controlled trials of mpox therapies are limited [ 6 , 7 ]. Global provision of tecovirimat was limited during the outbreak, even in high-resource settings [ 8 , 9 ].…”