Characteristics of Authorized Clinical Trials in Peru, 2017–2025: A National Registry-Based Study

Mendoza-Aucaruri L.; Acevedo-Cahuana A.G.; Villalba-Ugarte F.P.; Ttito-Paricahua L.; Ale-Mauricio D.A.; Taype-Rondan A. · Therapeutic Innovation and Regulatory Science (2026) · DOI: 10.1007/s43441-026-01040-9

Resumen

Background: In Peru, the regulatory framework governing clinical research has evolved substantially, particularly during the COVID-19 pandemic; however, recent patterns of authorized clinical trials (CTs) have not been systematically described. Objective: To characterize authorized CTs in Peru and to describe their evolution across the pre-pandemic (2017–2019), pandemic (2020–2022), and post-pandemic (2023–2025) periods. Methods: Retrospective descriptive study using secondary data from the Peruvian Clinical Trial Registry (REPEC). All CTs authorized between January 2017 and December 2025 were included. Trial, population, geographic, and regulatory characteristics were assessed. Categorical variables were compared using chi-square or Fisher’s exact tests, and continuous variables using the Kruskal–Wallis test. Results: A total of 421 authorized CTs were analyzed. Most were foreign-sponsored (90.0%) and conducted by private institutions (86.2%). Phase III trials (72.2%) with randomized (84.6%), double-blind (61.5%), and parallel designs (88.6%) predominated. Oncology was the most frequent therapeutic area (32.5%), while medical specialties varied across periods (p = 0.002), with infectious-disease trials increasing during the pandemic (24.9%) and declining thereafter (9.8%). Most trials planned to enroll both sexes (91.0%) and adults (92.6%); inclusion of older adults (≥ 65 years) differed by periods (p = 0.001). Most trials were planned to be conducted in Lima (96.4%). Median time to authorization was 75 days in 2020, peaked at 405.5 days in 2022, and declined to 127.5 days in 2025, remaining above pre-pandemic levels (90.5–109 days). Conclusions: Authorized CTs in Peru remain predominantly foreign-sponsored, late-phase, and geographically concentrated in the capital. The COVID-19 pandemic was associated with notable shifts in trial characteristics and substantial disruption of regulatory timelines, with only partial recovery thereafter. The CT profile appeared to show limited alignment with national health priorities, highlighting the importance of orienting clinical research toward population health needs. © The Author(s), under exclusive licence to The Drug Information Association, Inc 2026.

Instituciones: Universidad Científica del Sur; Universidad San Ignacio de Loyola; Universidad Nacional Jorge Basadre Grohmann; Universidad Nacional del Centro del Perú