{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T14:01:54Z","timestamp":1787061714816,"version":"build-2736575974"},"reference-count":30,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"16","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2024,6,1]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>In October 2017, an ASCO, Friends of Cancer Research (FoCR), and US Food and Drug Administration (ASCO\/FoCR\/FDA) task force recommended that common eligibility criteria be modified to make trials more inclusive. We examined whether patterns of exclusions regarding patients with brain metastases changed over time in relation to these recommendations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>Trial eligibility criteria were abstracted from ClinicalTrials.gov for phase I-III US-based interventional clinical trials for patients with advanced breast, colorectal, lung, or melanoma cancers from January 2012 to December 2022. Trials were examined to determine whether patients with brain metastases were not excluded, conditionally excluded (ie, excluded in some circumstances), or wholly excluded. An interrupted time series analysis with multinomial logistic regression was used to determine whether the ASCO\/FoCR\/FDA recommendations were associated with changes in brain metastases criteria.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>We evaluated N = 3,077 trials. Patients with brain metastases were not excluded in 506 trials (16.4%), conditionally excluded in 2,263 trials (73.5%), and wholly excluded in 308 trials (10.0%). In the postrecommendation period, we estimated a 68% increase in the odds of brain metastases not excluded compared with conditionally excluded (odds ratio, 1.68 [95% CI, 1.06 to 2.66], P = .03). The proportion of trials in which patients with brain metastases were not excluded increased (from 11.5% v 17.3%) and conditionally excluded decreased (from 82.3% to 75.2%, P = .03). We found no difference in the proportion of trials in which patients with brain metastases were wholly excluded (7.5% v 6.2%, P = .42).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>The ASCO\/FoCR\/FDA task force recommendations were associated with a shift in patterns of brain metastases exclusion criteria from conditionally excluded to not excluded. These findings demonstrate that the cancer clinical trial community has begun to change the way trials are written to be more inclusive.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco.23.01777","type":"journal-article","created":{"date-parts":[[2024,3,27]],"date-time":"2024-03-27T16:02:20Z","timestamp":1711555340000},"page":"1953-1960","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":14,"title":["Impact of Broadening Trial Eligibility Criteria on the Inclusion of Patients With Brain Metastases in Cancer Clinical Trials: Time Series Analyses for 2012-2022"],"prefix":"10.1200","volume":"42","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5113-2367","authenticated-orcid":false,"given":"Hong","family":"Xiao","sequence":"first","affiliation":[{"name":"Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5316-6352","authenticated-orcid":false,"given":"Riha","family":"Vaidya","sequence":"additional","affiliation":[{"name":"Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8807-153X","authenticated-orcid":false,"given":"Dawn L.","family":"Hershman","sequence":"additional","affiliation":[{"name":"Columbia University Medical Center, New York City, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5191-0317","authenticated-orcid":false,"given":"Joseph M.","family":"Unger","sequence":"additional","affiliation":[{"name":"Public Health Sciences Division, Fred Hutchinson Cancer Center, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"b1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2017.73.7916"},{"key":"b2","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-20-3853"},{"key":"b3","doi-asserted-by":"publisher","DOI":"10.1201\/b12125"},{"key":"b4","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2017.73.4186"},{"key":"b5","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtho.2017.08.003"},{"key":"b6","doi-asserted-by":"publisher","DOI":"10.1016\/j.cct.2012.02.009"},{"key":"b7","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtho.2017.07.020"},{"key":"b8","doi-asserted-by":"publisher","DOI":"10.1177\/2168479017713039"},{"key":"b9","doi-asserted-by":"publisher","DOI":"10.1200\/EDBK_156686"},{"key":"b10","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/dju002"},{"key":"b11","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2017.74.0761"},{"key":"b12","doi-asserted-by":"publisher","DOI":"10.1007\/s11940-013-0276-z"},{"key":"b14","volume-title":"Brain Metastasis","author":"Amsbaugh MJ","year":"2023"},{"key":"b15","doi-asserted-by":"publisher","DOI":"10.1097\/01.nrl.0000106922.83090.71"},{"key":"b16","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyaa148"},{"key":"b17","volume-title":"Making the Most of Statistical Analyses: Improving Interpretation and Presentation. Inter-university Consortium for Political and Social Research","author":"King G","year":"2002"},{"key":"b18","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2002.03.003"},{"key":"b19","doi-asserted-by":"publisher","DOI":"10.3389\/fonc.2021.780379"},{"key":"b20","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djac152"},{"key":"b21","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-20-3857"},{"key":"b22","doi-asserted-by":"publisher","DOI":"10.1093\/neuonc\/noab101"},{"key":"b23","volume-title":"Cancer Clinical Trial Eligibility Criteria: Brain Metastases Guidance for Industry","year":"2023"},{"key":"b24","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2021.39.15_suppl.6518"},{"key":"b25","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-20-3852"},{"key":"b26","first-page":"601","volume":"22","author":"Lee EQ","year":"2020","journal-title":"Neuro Oncol"},{"key":"b27","volume-title":"Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections Guidance for Industry","year":"2023"},{"key":"b28","volume-title":"Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies Guidance for Industry","year":"2023"},{"key":"b29","volume-title":"Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients Guidance for Industry","year":"2023"},{"key":"b30","volume-title":"Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry","author":"US Food and Durg Administration","year":"2022"},{"key":"b31","doi-asserted-by":"publisher","DOI":"10.1177\/2168479018782885"}],"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO.23.01777","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,29]],"date-time":"2024-05-29T18:00:12Z","timestamp":1717005612000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.23.01777"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,6,1]]},"references-count":30,"journal-issue":{"issue":"16","published-print":{"date-parts":[[2024,6,1]]}},"alternative-id":["10.1200\/JCO.23.01777"],"URL":"https:\/\/doi.org\/10.1200\/jco.23.01777","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,6,1]]},"assertion":[{"value":"2023-08-16","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-01-12","order":1,"name":"revised","label":"Revised","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-02-08","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-03-27","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}