{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T02:45:25Z","timestamp":1788230725105,"version":"build-2803163510"},"reference-count":14,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2024,4,25]],"date-time":"2024-04-25T00:00:00Z","timestamp":1714003200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Public Health"],"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Latin America (Latam) has a tradition of large-scale vaccine trials. Because of fluctuating demand, many sites have downsized their infrastructure. Therefore, BMGF launched a clinical trial site-readiness initiative early in the coronavirus-2019 (COVID-19) pandemic including Latam countries between August and September 2020. This survey evaluated clinical development performance measures pre\/post initiative (September 2022).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>20\/21 prequalified sites participated in COVID-19 vaccine\/drug development trials. 156 clinical trials (140 COVID-19 vaccine\/drug trials) were initiated in the 2\u2009years since prequalification, compared to 176 in the 5\u2009years before. 33,428\/37,810 participants were included in COVID-19 programs. The number of enrolled subjects\/day across sites quadrupled from 15 (1\u201335) to 63 (5\u2013300). The dropout rate was 6.8%. Study approval timelines were reduced from 60 (12\u2013120) to 35 (5\u201390) days. Mean qualified staff was increased from 24 (6\u201380) to 88 (22\u2013180).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Clinical trial sites across Latam were successfully prequalified to participate in COVID-19 developments. For the 100\u2009days mission of vaccine availability in a new pandemic sufficient and well-trained clinical trial sites readily available are essential. This is only achievable if sites\u2014especially in low\/middle-income countries\u2014are maintained active through a constant flow of vaccine studies.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fpubh.2024.1179268","type":"journal-article","created":{"date-parts":[[2024,4,25]],"date-time":"2024-04-25T04:58:55Z","timestamp":1714021135000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":3,"title":["Clinical trial capacity building in a pandemic\u2014outcome of a rapid site readiness project in Latin America"],"prefix":"10.3389","volume":"12","author":[{"given":"Sue Ann Costa","family":"Clemens","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabela","family":"Gonzalez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniele","family":"Sereni","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ralf","family":"Clemens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2024,4,25]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"286","DOI":"10.1177\/1740774520977283","article-title":"Mapping time use in clinical trials for vaccines against emerging infectious diseases","volume":"18","author":"Mandi","year":"2021","journal-title":"Clin Trials"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"1423","DOI":"10.1016\/S0140-6736(20)30414-1","article-title":"Efficacy of a 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