Publicação
Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis
| dc.contributor.author | Gates, Allison | |
| dc.contributor.author | Caldwell, Patrina | |
| dc.contributor.author | Curtis, Sarah | |
| dc.contributor.author | Dans, Leonila | |
| dc.contributor.author | Fernandes, Ricardo M. | |
| dc.contributor.author | Hartling, Lisa | |
| dc.contributor.author | Kelly, Lauren E. | |
| dc.contributor.author | Vandermeer, Ben | |
| dc.contributor.author | Williams, Katrina | |
| dc.contributor.author | Woolfall, Kerry | |
| dc.contributor.author | Dyson, Michele P. | |
| dc.date.accessioned | 2022-09-05T13:19:30Z | |
| dc.date.available | 2022-09-05T13:19:30Z | |
| dc.date.issued | 2019 | |
| dc.description | © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. | pt_PT |
| dc.description.abstract | Objectives: For 300 paediatric trials, we evaluated the reporting of: a data monitoring committee (DMC); interim analyses, stopping rules and early stopping; and adverse events and harm-related endpoints. Methods: For this cross-sectional evaluation, we randomly selected 300 paediatric trials published in 2012 from the Cochrane Central Register of Controlled Trials. We collected data on the reporting of a DMC; interim analyses, stopping rules and early stopping; and adverse events and harm-related endpoints. We reported the findings descriptively and stratified by trial characteristics. Results: Eighty-five (28%) of the trials investigated drugs, and 18% (n=55/300) reported a DMC. The reporting of a DMC was more common among multicentre than single centre trials (n=41/132, 31% vs n=14/139, 10%, p<0.001) and industry-sponsored trials compared with those sponsored by other sources (n=16/50, 32% vs n=39/250, 16%, p=0.009). Trials that reported a DMC enrolled more participants than those that did not (median [range]): 224 (10-60480) vs 91 (10-9528) (p<0.001). Only 25% of these trials reported interim analyses, and 42% reported stopping rules. Less than half (n=143/300, 48%) of trials reported on adverse events, and 72% (n=215/300) reported on harm-related endpoints. Trials that reported a DMC compared with those that did not were more likely to report adverse events (n=43/55, 78% vs 100/245, 41%, p<0.001) and harm-related endpoints (n=52/55, 95% vs. 163/245, 67%, p<0.001). Only 32% of drug trials reported a DMC; 18% and 19% did not report on adverse events or harm-related endpoints, respectively. Conclusions: The reporting of a DMC was infrequent, even among drug trials. Few trials reported stopping rules or interim analyses. Reporting of adverse events and harm-related endpoints was suboptimal. | pt_PT |
| dc.description.sponsorship | This work was supported by the Canadian Institutes of Health Research (#KRS 140989) | pt_PT |
| dc.description.version | info:eu-repo/semantics/publishedVersion | pt_PT |
| dc.identifier.citation | BMJ Paediatr Open. 2019 Mar 20;3(1):e000426 | pt_PT |
| dc.identifier.doi | 10.1136/bmjpo-2018-000426 | pt_PT |
| dc.identifier.eissn | 2399-9772 | |
| dc.identifier.uri | http://hdl.handle.net/10451/54297 | |
| dc.language.iso | eng | pt_PT |
| dc.peerreviewed | yes | pt_PT |
| dc.publisher | BMJ Publishing Group | pt_PT |
| dc.relation.publisherversion | https://bmjpaedsopen.bmj.com/ | pt_PT |
| dc.rights.uri | http://creativecommons.org/licenses/by-nc/4.0/ | pt_PT |
| dc.subject | Data collection | pt_PT |
| dc.subject | Ethics | pt_PT |
| dc.subject | General paediatrics | pt_PT |
| dc.title | Reporting of data monitoring committees and adverse events in paediatric trials: a descriptive analysis | pt_PT |
| dc.type | journal article | |
| dspace.entity.type | Publication | |
| oaire.citation.issue | 1 | pt_PT |
| oaire.citation.title | BMJ Paediatrics Open | pt_PT |
| oaire.citation.volume | 3 | pt_PT |
| person.familyName | Fernandes | |
| person.givenName | Ricardo | |
| person.identifier | 309018 | |
| person.identifier.orcid | 0000-0002-7253-6475 | |
| person.identifier.rid | C-7501-2015 | |
| person.identifier.scopus-author-id | 24436565500 | |
| rcaap.rights | openAccess | pt_PT |
| rcaap.type | article | pt_PT |
| relation.isAuthorOfPublication | 862be38f-2247-424c-b26c-d3bdda4474be | |
| relation.isAuthorOfPublication.latestForDiscovery | 862be38f-2247-424c-b26c-d3bdda4474be |