ArticleTherapeutic innovation & regulatory science2026
Characteristics of Authorized Clinical Trials in Peru, 2017-2025: A National Registry-Based Study.
Article in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn 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.
objectiveTo 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.
methodsRetrospective 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.
resultsA 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).
conclusionsAuthorized 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.
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Identifiers
42671713What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.