{"id":"https://openalex.org/W4401905903","doi":"https://doi.org/10.1056/evidctw2400058","title":"The Case for Access to Data Monitoring Committee Charters","display_name":"The Case for Access to Data Monitoring Committee Charters","publication_year":2024,"publication_date":"2024-08-27","ids":{"openalex":"https://openalex.org/W4401905903","doi":"https://doi.org/10.1056/evidctw2400058","pmid":"https://pubmed.ncbi.nlm.nih.gov/39189859"},"language":"en","primary_location":{"id":"doi:10.1056/evidctw2400058","doi":"https://doi.org/10.1056/evidctw2400058","is_oa":false,"landing_page_url":"https://doi.org/10.1056/evidctw2400058","pdf_url":null,"source":{"id":"https://openalex.org/S4210196357","display_name":"NEJM Evidence","issn_l":"2766-5526","issn":["2766-5526"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","doyens","jufo-1","ki-jl-1","medline","norway-1"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"NEJM Evidence","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5000030255","display_name":"Deborah A. Zarin","orcid":"https://orcid.org/0000-0002-4579-2801","observed_orcids":["https://orcid.org/0000-0002-4579-2801"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Deborah Zarin","raw_affiliation_strings":["Retired, Chevy Chase, MD"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Retired, Chevy Chase, MD","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5019521007","display_name":"Janet Turk Wittes","orcid":"https://orcid.org/0000-0002-6625-835X","observed_orcids":["https://orcid.org/0000-0002-6625-835X"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Janet T. Wittes","raw_affiliation_strings":["Wittes LLC, Washington, DC"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Wittes LLC, Washington, DC","institution_ids":[]}]},{"author_position":"middle","author":{"id":null,"display_name":"Thomas R. Fleming","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I201448701","display_name":"University of Washington","ror":"https://ror.org/00cvxb145","country_code":"US","type":"education","lineage":["https://openalex.org/I201448701"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Thomas R. Fleming","raw_affiliation_strings":["University of Washington, Seattle"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Washington, Seattle","institution_ids":["https://openalex.org/I201448701"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5088017620","display_name":"Frank W. Rockhold","orcid":"https://orcid.org/0000-0003-3732-4765","observed_orcids":["https://orcid.org/0000-0003-3732-4765"]},"institutions":[{"id":"https://openalex.org/I4210126298","display_name":"Duke Medical Center","ror":"https://ror.org/03njmea73","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210126298","https://openalex.org/I4210144876"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Frank Rockhold","raw_affiliation_strings":["Duke University Medical Center, Durham, NC"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Duke University Medical Center, Durham, NC","institution_ids":["https://openalex.org/I4210126298"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5031001812","display_name":"Susan S. Ellenberg","orcid":"https://orcid.org/0000-0002-2364-5253","observed_orcids":["https://orcid.org/0000-0002-2364-5253"]},"institutions":[{"id":"https://openalex.org/I79576946","display_name":"University of Pennsylvania","ror":"https://ror.org/00b30xv10","country_code":"US","type":"education","lineage":["https://openalex.org/I79576946"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Susan Ellenberg","raw_affiliation_strings":["University of Pennsylvania, Philadelphia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Pennsylvania, Philadelphia","institution_ids":["https://openalex.org/I79576946"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5108358299","display_name":"David L. DeMets","orcid":"https://orcid.org/0000-0003-3348-8754","observed_orcids":["https://orcid.org/0000-0003-3348-8754"]},"institutions":[{"id":"https://openalex.org/I135310074","display_name":"University of Wisconsin\u2013Madison","ror":"https://ror.org/01y2jtd41","country_code":"US","type":"education","lineage":["https://openalex.org/I135310074"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"David L. DeMets","raw_affiliation_strings":["University of Wisconsin\u2013Madison, Madison"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Wisconsin\u2013Madison, Madison","institution_ids":["https://openalex.org/I135310074"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":4,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.345,"has_fulltext":false,"cited_by_count":1,"citation_normalized_percentile":{"value":0.59859175,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":89,"max":93},"biblio":{"volume":"3","issue":"9","first_page":"EVIDctw2400058","last_page":"EVIDctw2400058"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10582","display_name":"Ethics in Clinical Research","score":0.7734000086784363,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10582","display_name":"Ethics in Clinical Research","score":0.7734000086784363,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.13179999589920044,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T11649","display_name":"Pharmaceutical industry and healthcare","score":0.03779999911785126,"subfield":{"id":"https://openalex.org/subfields/2910","display_name":"Issues, ethics and legal aspects"},"field":{"id":"https://openalex.org/fields/29","display_name":"Nursing"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/data-monitoring-committees","display_name":"data monitoring committees","score":0.9980000257492065},{"id":"https://openalex.org/keywords/clinicaltrials-gov","display_name":"ClinicalTrials.gov","score":0.7570000290870667},{"id":"https://openalex.org/keywords/clinical-trial-transparency","display_name":"clinical trial transparency","score":0.6639999747276306}],"concepts":[{"id":"https://openalex.org/C2776957806","wikidata":"https://www.wikidata.org/wiki/Q4895105","display_name":"Interim","level":2,"score":0.8432444930076599},{"id":"https://openalex.org/C73751289","wikidata":"https://www.wikidata.org/wiki/Q2985397","display_name":"Data monitoring committee","level":3,"score":0.7082294821739197},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.6305987238883972},{"id":"https://openalex.org/C2777596936","wikidata":"https://www.wikidata.org/wiki/Q727002","display_name":"Charter","level":2,"score":0.5860335826873779},{"id":"https://openalex.org/C27415008","wikidata":"https://www.wikidata.org/wiki/Q7256382","display_name":"Psychological intervention","level":2,"score":0.584654688835144},{"id":"https://openalex.org/C61943457","wikidata":"https://www.wikidata.org/wiki/Q6046661","display_name":"Interim analysis","level":3,"score":0.5722811818122864},{"id":"https://openalex.org/C68122502","wikidata":"https://www.wikidata.org/wiki/Q764527","display_name":"Informed consent","level":3,"score":0.48936933279037476},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.42528656125068665},{"id":"https://openalex.org/C19527891","wikidata":"https://www.wikidata.org/wiki/Q1120908","display_name":"Medical physics","level":1,"score":0.4175569713115692},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.34713780879974365},{"id":"https://openalex.org/C204787440","wikidata":"https://www.wikidata.org/wiki/Q188504","display_name":"Alternative medicine","level":2,"score":0.27686846256256104},{"id":"https://openalex.org/C17744445","wikidata":"https://www.wikidata.org/wiki/Q36442","display_name":"Political science","level":0,"score":0.19986668229103088},{"id":"https://openalex.org/C199539241","wikidata":"https://www.wikidata.org/wiki/Q7748","display_name":"Law","level":1,"score":0.17342883348464966},{"id":"https://openalex.org/C159110408","wikidata":"https://www.wikidata.org/wiki/Q121176","display_name":"Nursing","level":1,"score":0.14077255129814148},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D022126","descriptor_name":"Access to Information","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D026661","descriptor_name":"Clinical Trials Data Monitoring Committees","qualifier_ui":"Q000458","qualifier_name":"organization & administration","is_major_topic":true}],"locations_count":2,"locations":[{"id":"doi:10.1056/evidctw2400058","doi":"https://doi.org/10.1056/evidctw2400058","is_oa":false,"landing_page_url":"https://doi.org/10.1056/evidctw2400058","pdf_url":null,"source":{"id":"https://openalex.org/S4210196357","display_name":"NEJM Evidence","issn_l":"2766-5526","issn":["2766-5526"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","doyens","jufo-1","ki-jl-1","medline","norway-1"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"NEJM Evidence","raw_type":"journal-article"},{"id":"pmid:39189859","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/39189859","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"NEJM evidence","raw_type":"Journal Article"}],"best_oa_location":null,"sustainable_development_goals":[],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":22,"referenced_works":["https://openalex.org/W1593442063","https://openalex.org/W2084652988","https://openalex.org/W2120266819","https://openalex.org/W2135570662","https://openalex.org/W2494138785","https://openalex.org/W2520965749","https://openalex.org/W2529207539","https://openalex.org/W2581784150","https://openalex.org/W2592372544","https://openalex.org/W2614168425","https://openalex.org/W2987102569","https://openalex.org/W4206617123","https://openalex.org/W4213379760","https://openalex.org/W4224862983","https://openalex.org/W4225741213","https://openalex.org/W4246560643","https://openalex.org/W4283704661","https://openalex.org/W4292723325","https://openalex.org/W4317901037","https://openalex.org/W4378349275","https://openalex.org/W4385795059","https://openalex.org/W4388339868"],"related_works":["https://openalex.org/W4378349275","https://openalex.org/W4417189754","https://openalex.org/W4388339868","https://openalex.org/W2247856738","https://openalex.org/W7162257726","https://openalex.org/W2062848956","https://openalex.org/W2153627969","https://openalex.org/W4410409942","https://openalex.org/W3209510660","https://openalex.org/W4410620470"],"abstract_inverted_index":{"AbstractClinical":[0],"trials":[1,82],"investigating":[2],"novel":[3],"or":[4],"high-risk":[5],"interventions":[6],"often":[7],"use":[8],"data":[9],"monitoring":[10,43],"committees":[11],"(DMCs)":[12],"to":[13,69],"ensure":[14],"that":[15],"the":[16,30,70,86],"participants'":[17],"best":[18],"interests":[19],"are":[20,56,100],"safeguarded.":[21],"The":[22],"typical":[23],"DMC":[24,31,48,78],"charter":[25],"describes":[26],"procedures":[27],"by":[28],"which":[29],"operates,":[32],"including":[33,77],"important":[34,68],"details":[35],"concerning":[36],"organizational":[37],"structure,":[38],"membership,":[39],"meeting":[40],"frequency,":[41],"statistical":[42,97],"guidelines,":[44],"and":[45,96],"contents":[46],"of":[47,72,88],"reports":[49],"for":[50,80],"interim":[51],"review.":[52],"These":[53],"charters,":[54],"however,":[55],"not":[57],"routinely":[58],"publicly":[59],"available;":[60],"in":[61,83,103],"some":[62],"cases,":[63],"their":[64],"access":[65],"could":[66],"be":[67],"interpretation":[71],"trial":[73,89,91],"results.":[74],"We":[75],"recommend":[76],"charters":[79],"such":[81],"ClinicalTrials.gov":[84],"at":[85],"time":[87],"completion;":[90],"protocols,":[92],"informed":[93],"consent":[94],"documents,":[95],"analysis":[98],"plans":[99],"already":[101],"available":[102],"this":[104],"repository.":[105]},"counts_by_year":[{"year":2025,"cited_by_count":1}],"updated_date":"2026-11-05T12:25:35.769452","created_date":"2024-08-28T00:00:00"}
