{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T10:11:56Z","timestamp":1777543916282,"version":"3.51.4"},"reference-count":30,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2023,6,27]],"date-time":"2023-06-27T00:00:00Z","timestamp":1687824000000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Clinical Trials"],"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Data monitoring committees advise on clinical trial conduct through appraisal of emerging data to ensure participant safety and scientific integrity. While consideration of their use is recommended for trials performed with vulnerable populations, previous research has shown that data monitoring committees are reported infrequently in publications of pediatric randomized controlled trials. We aimed to assess the frequency of reported data monitoring committee adoption in ClinicalTrials.gov registry records and to examine the influence of key trial characteristics.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a cross-sectional data analysis of all randomized controlled trials performed exclusively in a pediatric population and registered in ClinicalTrials.gov between 2008 and 2021. We used the Access to Aggregate Content of ClinicalTrials.gov database to retrieve publicly available information on trial characteristics and data on safety results. Abstracted data included reported trial design and conduct parameters, population and intervention characteristics, reasons for prematurely halting, serious adverse events, and mortality outcomes. We performed descriptive analyses on the collected data and explored the influence of clinical, methodological, and operational trial characteristics on the reported adoption of data monitoring committees.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We identified 13,928 pediatric randomized controlled trial records, of which 39.7% reported adopting a data monitoring committee, 49.0% reported not adopting a data monitoring committee, and 11.3% did not answer on this item. While the number of registered pediatric trials has been increasing since 2008, we found no clear time trend in the reported adoption of data monitoring committees. Data monitoring committees were more common in multicenter trials (50.6% vs 36.9% for single-center), multinational trials (60.2% vs 38.7% for single-country), National Institutes of Health\u2013funded (60.3% vs 40.1% for industry-funded or 37.5% for other funders), and placebo-controlled (47.6% vs 37.5% for other types of control groups). Data monitoring committees were also more common among trials enrolling younger participants, trials employing blinding techniques, and larger trials. Data monitoring committees were more common in trials with at least one serious adverse event (52.6% vs 38.4% for those without) as well as for trials with reported deaths (70.3% vs 38.9% for trials without reported deaths). In all, 4.9% were listed as halted prematurely, most often due to low accrual rates. Trials with a data monitoring committee were more often halted for reasons related to scientific data than trials without a data monitoring committee (15.7% vs 7.3%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>According to registry records, the use of data monitoring committees in pediatric randomized controlled trials was more frequent than previously reported in reviews of published trial reports. The use of data monitoring committees varied across key clinical and trial characteristics based on which their use is recommended. Data monitoring committees may still be underutilized in pediatric trials, and reporting of this item could be improved.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17407745231182417","type":"journal-article","created":{"date-parts":[[2023,6,27]],"date-time":"2023-06-27T06:23:36Z","timestamp":1687847016000},"page":"624-631","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Data monitoring committees in pediatric randomized controlled trials registered in ClinicalTrials.gov"],"prefix":"10.1177","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8930-4382","authenticated-orcid":false,"given":"Tiago","family":"Machado","sequence":"first","affiliation":[{"name":"Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal"},{"name":"Instituto de Medicina Molecular Jo\u00e3o Lobo Antunes, Lisbon, Portugal"}]},{"given":"Beatrice","family":"Mainoli","sequence":"additional","affiliation":[{"name":"Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal"},{"name":"Instituto de Medicina Molecular Jo\u00e3o Lobo Antunes, Lisbon, Portugal"},{"name":"Clinical Research Unit, Research Center of IPO Porto (CI-IPOP), Porto, Portugal"}]},{"given":"Daniel","family":"Caldeira","sequence":"additional","affiliation":[{"name":"Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal"},{"name":"Instituto de Medicina Molecular Jo\u00e3o Lobo Antunes, Lisbon, Portugal"}]},{"given":"Joaquim J","family":"Ferreira","sequence":"additional","affiliation":[{"name":"Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal"},{"name":"Instituto de Medicina Molecular Jo\u00e3o Lobo Antunes, Lisbon, Portugal"},{"name":"Campus Neurol\u00f3gico S\u00e9nior (CNS), Torres Vedras, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7253-6475","authenticated-orcid":false,"given":"Ricardo M","family":"Fernandes","sequence":"additional","affiliation":[{"name":"Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, Universidade de Lisboa, Lisbon, Portugal"},{"name":"Instituto de Medicina Molecular Jo\u00e3o Lobo Antunes, Lisbon, Portugal"},{"name":"Department of Pediatrics, Santa Maria Hospital, Centro Hospitalar Universit\u00e1rio Lisboa Norte, Lisbon, Portugal"}]}],"member":"179","published-online":{"date-parts":[[2023,6,27]]},"reference":[{"key":"bibr1-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1002\/9781119512684"},{"issue":"1","key":"bibr2-17407745231182417","first-page":"005","volume":"1","author":"Evans SR.","year":"2022","journal-title":"New Engl J Med Evid"},{"key":"bibr3-17407745231182417","unstructured":"FDA Guidance for Clinical Trial Sponsors. Establishment and operation of clinical trial data monitoring committees, 2006, https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/establishment-and-operation-clinical-trial-data-monitoring-committees"},{"key":"bibr4-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1002\/sim.2585"},{"key":"bibr5-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2012-0055F"},{"key":"bibr6-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2431-9-77"},{"key":"bibr7-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1136\/bmjpo-2018-000426"},{"key":"bibr8-17407745231182417","unstructured":"Food and Drug Administration Amendments Act of 2007, Public Law 110-85, 2007, www.gpo.gov\/fdsys\/pkg\/PLAW-110publ85\/pdf\/PLAW-110publ85.pdf"},{"key":"bibr9-17407745231182417","unstructured":"AACT Database. Clinical trials transformation initiative, https:\/\/aact.ctti-clinicaltrials.org\/ (accessed 11 July 2022)."},{"key":"bibr10-17407745231182417","unstructured":"RStudio. Open source professional software for data science teams, https:\/\/www.rstudio.com\/ (accessed 11 July 2022)."},{"key":"bibr11-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0127242"},{"key":"bibr12-17407745231182417","unstructured":"ClinicalTrials.gov. Glossary of Common Site Terms, https:\/\/clinicaltrials.gov\/ct2\/about-studies\/glossary (accessed 24 June 2022)."},{"key":"bibr13-17407745231182417","unstructured":"ClinicalTrials.gov. Protocol registration data element definitions for interventional and observational studies, https:\/\/prsinfo.clinicaltrials.gov\/definitions.html (accessed 24 June 2022)."},{"key":"bibr14-17407745231182417","unstructured":"ClinicalTrials.gov. Results data element definitions for interventional and observational studies, https:\/\/prsinfo.clinicaltrials.gov\/results_definitions.html (accessed 24 June 2022)."},{"key":"bibr15-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2012-0055I"},{"key":"bibr16-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2016-0223"},{"key":"bibr17-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.c332"},{"key":"bibr18-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(05)17965-3"},{"key":"bibr19-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1002\/sim.730"},{"key":"bibr20-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(05)17965-3"},{"key":"bibr21-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-016-1551-6"},{"key":"bibr22-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-019-3408-2"},{"key":"bibr23-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1038\/s41597-020-00780-z"},{"key":"bibr24-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0084727"},{"key":"bibr25-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMsr1611785"},{"key":"bibr26-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.k1452"},{"key":"bibr27-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)33220-9"},{"key":"bibr28-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1186\/s12916-018-1168-6"},{"key":"bibr29-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2020.12.016"},{"key":"bibr30-17407745231182417","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2022.01.012"}],"container-title":["Clinical Trials"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17407745231182417","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/17407745231182417","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17407745231182417","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,28]],"date-time":"2026-04-28T17:28:49Z","timestamp":1777397329000},"score":1,"resource":{"primary":{"URL":"http:\/\/journals.sagepub.com\/doi\/10.1177\/17407745231182417"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,6,27]]},"references-count":30,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2023,12]]}},"alternative-id":["10.1177\/17407745231182417"],"URL":"https:\/\/doi.org\/10.1177\/17407745231182417","relation":{},"ISSN":["1740-7745","1740-7753"],"issn-type":[{"value":"1740-7745","type":"print"},{"value":"1740-7753","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,6,27]]}}}