Decade of Progress: Ethical and Regulatory Approval Timelines for Cancer Clinical Trials in Brazil.

PURPOSE: Brazil represents a promising environment for clinical research, supported by a genetically diverse population and established research infrastructure. Despite this, participation in global oncology trials remains limited, with study approval timelines among the contributing factors. Recent regulatory reforms have aimed to streamline review processes. This study evaluated ethical and regulatory approval timelines for oncology trials in Brazil. METHODS: We performed a retrospective analysis using data on regulatory approval timelines for oncology clinical trials managed by Contract Research Organizations in Brazil. A total of 196 phase I-IV trials conducted between 2013 and 2023 were included. Timelines were calculated in days from protocol submission to first response and final decision by the National Commission for Ethics in Research (Comissão Nacional de Ética em Pesquisa [CONEP]) and the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária [ANVISA]). Data were stratified into four periods: (I) preimplementation of ANVISA Collegiate Board Resolutions (Resoluções da Diretoria Colegiada) 09 and 10/2015, (II) pre-COVID-19, (III) during COVID-19, and (IV) postpandemic/current (May 2022-December 2023). RESULTS: Over the last decade, approval times decreased substantially. ANVISA's mean final approval time fell from 341 days in 2013 to 90 days in 2023, whereas CONEP's decreased from 164 to 141 days. Period analysis showed ANVISA's mean time frame declined from 309 days (period I) to 99 days (period IV). CONEP's mean time frame dropped from 266 days (period I) to 128 days prepandemic, with a slight increase to 172 days in the postpandemic/current period. CONCLUSION: Brazil's regulatory and ethical approval processes have shown significant and sustained improvement. Recent legislation introducing centralized ethical review and mandatory response deadlines is expected to further enhance Brazil's competitiveness in global oncology research.