{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,2]],"date-time":"2025-11-02T14:30:48Z","timestamp":1762093848607,"version":"build-2065373602"},"reference-count":32,"publisher":"SAGE Publications","issue":"4","license":[{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T00:00:00Z","timestamp":1759276800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Multiple Sclerosis Journal \u2013 Experimental, Translational and Clinical"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Evaluating safety of emerging interventions is important in clinical trials. To support reporting of safety outcomes, a harms extension of the Consolidated Standards of Reporting Trial (CONSORT) guidelines was published in 2004.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To examine safety reporting in pivotal trials of disease-modifying therapies (DMTs) in patients with multiple sclerosis (MS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Published phase III clinical trials from 1995 to 2022 included in FDA approval material for MS DMTs were compiled and reviewed by two independent examiners. Criteria derived from the CONSORT harms extension were used to evaluate safety reporting. Linear regression was applied to examine associations between quality of safety reporting and study level factors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      30 publications were included in the analysis. Overall, safety reporting quality was fair with an average score of 10.2 out of 15. Trials examining small molecule versus biologic interventions (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      = 0.001) and recent publication (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      = 0.005) were associated with higher quality reporting. Items related to laboratory-defined toxicity and defining adverse events were among reporting items notably lacking (present in 53% and 40% of publications, respectively).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>While the reporting of phase III clinical trials for DMTs for the treatment of MS has improved with time, there remain gaps and opportunities for further improvement.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/20552173251390649","type":"journal-article","created":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T16:39:02Z","timestamp":1761755942000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Safety reporting quality in multiple sclerosis clinical trials: A review of phase III clinical trials included in FDA approval of disease-modifying treatments"],"prefix":"10.1177","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3610-5213","authenticated-orcid":false,"given":"William Z.","family":"Lin","sequence":"first","affiliation":[{"name":"University of British Columbia"},{"name":"International Collaboration on Repair Discoveries (ICORD), University of British Columbia"},{"name":"University of Toronto"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-6246-2773","authenticated-orcid":false,"given":"Jaimie J.","family":"Lee","sequence":"additional","affiliation":[{"name":"University of British Columbia"},{"name":"International Collaboration on Repair Discoveries (ICORD), University of British Columbia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8645-6134","authenticated-orcid":false,"given":"Anibal","family":"Chertcoff","sequence":"additional","affiliation":[{"name":"University of British Columbia"},{"name":"Djavad Mowafaghian Centre for Brain Health"},{"name":"Max Rady College of Medicine, University of Manitoba"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5804-2535","authenticated-orcid":false,"given":"Helen","family":"Tremlett","sequence":"additional","affiliation":[{"name":"University of British Columbia"},{"name":"Djavad Mowafaghian Centre for Brain Health"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John L. 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