{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,8]],"date-time":"2026-03-08T17:05:10Z","timestamp":1772989510091,"version":"3.50.1"},"reference-count":17,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,11,5]],"date-time":"2025-11-05T00:00:00Z","timestamp":1762300800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,11,5]],"date-time":"2025-11-05T00:00:00Z","timestamp":1762300800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100000065","name":"National Institute of Neurological Disorders and Stroke","doi-asserted-by":"publisher","award":["1OT2NS136938\u201001"],"award-info":[{"award-number":["1OT2NS136938\u201001"]}],"id":[{"id":"10.13039\/100000065","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000065","name":"National Institute of Neurological Disorders and Stroke","doi-asserted-by":"publisher","award":["1OT2NS136939\u201001"],"award-info":[{"award-number":["1OT2NS136939\u201001"]}],"id":[{"id":"10.13039\/100000065","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Muscle and Nerve"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction\/Aims<\/jats:title>\n                    <jats:p>In global amyotrophic lateral sclerosis (ALS) trials, women and men appear to be proportionately enrolled, but quantification of enrollment by sex and race in U.S.\u2010based ALS trials is limited. The objective of this study was to evaluate the sex and race of participants enrolled in U.S.\u2010based ALS clinical trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Participant demographics were extracted from recent U.S.\u2010based Phase 2 and 3 ALS trials identified in literature and on\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      . The Centers for Disease Control and Prevention (CDC) National ALS Registry and a 2014 State Surveillance Project were used as proxies for prevalence. Participation\u2010to\u2010prevalence (PPR) ratios were calculated for sex and race. A modified time\u2010trend analysis was performed for race for participants enrolled before and after 2020.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 11 trials met criteria for inclusion with a total of 1153 patients enrolled. Compared to the CDC Registry, the PPR was 0.76 (95% CI: 0.63\u20130.90) for women, 1.26 (95% CI: 1.23\u20131.29) for White participants, 0.34 (95% CI: 0.17\u20130.51) for Black participants, and 0.35 (95% CI: 0.14\u20130.56) for all other races\/multiracial. The modified time trend analysis showed no significant difference in the PPRs before and after 2020 (White:\n                      <jats:italic>t<\/jats:italic>\n                      \u2009=\u20091.44,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.22; Black:\n                      <jats:italic>t<\/jats:italic>\n                      \u2009=\u2009\u22120.99,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.37; Other races\/multiracial:\n                      <jats:italic>t<\/jats:italic>\n                      \u2009=\u2009\u22121.50,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.21). The comparison to the 2014 State Surveillance Project yielded similar findings.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>U.S.\u2010based ALS trials significantly under\u2010enroll non\u2010White participants, and there are trends toward slight underrepresentation of women. Efforts to broaden trial enrollment amongst people with ALS will help with the generalizability of trial results and hasten trial completion.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/mus.70050","type":"journal-article","created":{"date-parts":[[2025,11,6]],"date-time":"2025-11-06T07:36:56Z","timestamp":1762414616000},"page":"50-55","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Participation in U.S.\u2010Based\n                    <scp>ALS<\/scp>\n                    Clinical Trials by Sex and Race"],"prefix":"10.1002","volume":"73","author":[{"given":"Mark P.","family":"Levine","sequence":"first","affiliation":[{"name":"Department of Neurology Emory University School of Medicine  Atlanta Georgia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sun Young","family":"Chung","sequence":"additional","affiliation":[{"name":"Department of Neurology New York\u2010Presbyterian Weill Cornell Medical Center  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kellen H.","family":"Quigg","sequence":"additional","affiliation":[{"name":"Department of Neurology University of Michigan  Ann Arbor Michigan USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Judith","family":"Carey","sequence":"additional","affiliation":[{"name":"Sean M. Healey &amp; AMG Center for ALS, Massachusetts General Hospital  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Suma","family":"Babu","sequence":"additional","affiliation":[{"name":"Sean M. Healey &amp; AMG Center for ALS, Massachusetts General Hospital  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sabrina","family":"Paganoni","sequence":"additional","affiliation":[{"name":"Sean M. Healey &amp; AMG Center for ALS, Massachusetts General Hospital  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James D.","family":"Berry","sequence":"additional","affiliation":[{"name":"Sean M. Healey &amp; AMG Center for ALS, Massachusetts General Hospital  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2025,11,5]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/ana.26714"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1080\/21678421.2024.2358793"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40615\u2010024\u201002047\u20104"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1212\/wnl.0000000000000951"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.12640"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/jnnp-2021-328470"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1080\/21678421.2023.2245858"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.3109\/21678421.2014.971813"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1089\/jwh.2012.3753"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/oncolo\/oyad009"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/jgs.18645"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jns.2019.116650"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1212\/wnl.0000000000011396"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1080\/21678421.2023.2273361"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.3233\/jpd\u2010191901"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1161\/strokeaha.118.024241"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejmp2215609"}],"container-title":["Muscle &amp; Nerve"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/mus.70050","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/mus.70050","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/mus.70050","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,8]],"date-time":"2026-03-08T11:57:23Z","timestamp":1772971043000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/mus.70050"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,5]]},"references-count":17,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,1]]}},"alternative-id":["10.1002\/mus.70050"],"URL":"https:\/\/doi.org\/10.1002\/mus.70050","archive":["Portico"],"relation":{},"ISSN":["0148-639X","1097-4598"],"issn-type":[{"value":"0148-639X","type":"print"},{"value":"1097-4598","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11,5]]},"assertion":[{"value":"2025-05-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-15","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-11-05","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}