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The discussion covers interim data handling around regulatory decisions, limited “need to know” access for non-DMC roles, ongoing unblinded safety and efficacy review for DMC members, and governance steps using contract and charter structures.",{"@graph":14,"@context":65},[15,34,56],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/template/","Template",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/template/presentations/","Presentations",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/template/data-monitoring-committees-current-issues-abstract-and-key-best-practices-for-confidentiality-and-independence/282897/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/data-monitoring-committees-current-issues-abstract-and-key-best-practices-for-confidentiality-and-independence/282897.png","ImageObject",442,249,{"name":42,"@type":43},"Kyle","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/pdf","2026-10-19","2026-09-16",true,{"@type":52,"interactionType":53,"userInteractionCount":55},"InteractionCounter",{"@type":54},"ViewAction",9,{"@type":57,"mainEntity":58},"FAQPage",[59],{"name":60,"@type":61,"acceptedAnswer":62},"In what rare situations might a mediator be useful according to the document?","Question",{"text":63,"@type":64},"A mediator could be useful when the DMC has serious ethical or scientific concerns about the sponsor’s dissemination or lack of dissemination of information.","Answer","https://schema.org",{"og:url":32,"og:type":67,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":69,"canonical":32},"index,follow",{"doc_id":71,"site_id":7},282897,1791729610,{"code":4,"msg":74,"data":75},"success",[76,80,85,90,95,100,105,110,115],{"id":77,"doc_module":22,"doc_module_name":25,"category_name":29,"show_sort_weight":78,"slug":79},11,90,"presentations",{"id":81,"doc_module":22,"doc_module_name":25,"category_name":82,"show_sort_weight":83,"slug":84},12,"Resumes",80,"resumes",{"id":86,"doc_module":22,"doc_module_name":25,"category_name":87,"show_sort_weight":88,"slug":89},14,"Invoices",70,"invoices",{"id":91,"doc_module":22,"doc_module_name":25,"category_name":92,"show_sort_weight":93,"slug":94},15,"Posters",60,"posters",{"id":96,"doc_module":22,"doc_module_name":25,"category_name":97,"show_sort_weight":98,"slug":99},16,"Social Media",50,"social-media",{"id":101,"doc_module":22,"doc_module_name":25,"category_name":102,"show_sort_weight":103,"slug":104},17,"Forms",40,"forms",{"id":106,"doc_module":22,"doc_module_name":25,"category_name":107,"show_sort_weight":108,"slug":109},18,"Letters",30,"letters",{"id":111,"doc_module":22,"doc_module_name":25,"category_name":112,"show_sort_weight":113,"slug":114},21,"Paper Templates",5,"papers-templates",{"id":116,"doc_module":22,"doc_module_name":25,"category_name":117,"show_sort_weight":4,"slug":118},158,"General","general-158",{"code":4,"msg":74,"data":120},{"doc_id":71,"user_id":121,"nickname":42,"user_avatar":122,"doc_module":22,"category_id":77,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":123,"file_id":124,"file_url":125,"file_type":126,"file_size":127,"view_count":55,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":128,"language":129,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":130,"faqs":131,"seo_title":132,"seo_description":12,"update_tm":133,"read_time":30},3985741905716,"https://ap-avatar.wpscdn.com/davatar_994ba38a5ba835b3df7d355c54d3ed8d","Conference Proceedings  \nData Monitoring Committees: Current issues  \nThomas R Fleming 1, Susan S Ellenberg2 and David L DeMets3  \nClinical Trials  \n2018, Vol. 15(4) 321–328  \n􀀂 The Author(s) 2018  \nReprints and permissions: [sagepub.co.uk/journalsPermissions.nav](sagepub.co.uk/journalsPermissions.nav)[ ](sagepub.co.uk/journalsPermissions.nav)[DOI: 10.1177/1740774518764855](DOI: 10.1177/1740774518764855)[ ](DOI: 10.1177/1740774518764855)[journals.sagepub.com/home/ctj](journals.sagepub.com/home/ctj)  \nAbstract  \nMaintaining confidentiality of emerging data and ensuring the independence of Data Monitoring Committees are best practices of considerable importance to the ability of these committees to achieve their mission of safeguarding the interests of study participants and enhancing the integrity and credibility of clinical trials. Even with the wide recognition of these principles, there are circumstances where confidentiality issues remain challenging, controversial or inconsistently addressed. First, consider settings where a clinical trial’s interim data could provide the evidence regulatory authorities require for decisions about marketing approval, yet where such a trial would be continued post-approval to provide more definitive evidence about principal safety and/or efficacy outcomes. In such settings, data informative about the longer term objectives of the trial should remain confidential until pre-specified criteria for trial completion have been met. Second, for those other than Data Monitoring Committee members, access to safety and efficacy outcomes during trial conduct, even when presented as data pooled across treatment arms, should be on a limited ‘‘need to know’’basis relating to the ability to carry out ethical or scientific responsibilities in the conduct of the trial. Third, Data Monitoring Committee members should have access to unblinded efficacy and safety data throughout the trial to enable timely and informed judgments about risks and benefits. Fourth, it should be recognized that a mediator potentially could be useful in rare settings where the Data Monitoring Committee would have serious ethical or scientific concerns about the sponsor’s dissemination or lack of dissemination of information. Data Monitoring Committee Contract Agreements, Indemnification Agreements and Charters should be developed in a manner to protect Data Monitoring Committee members and their independence, in order to enhance the Data Monitoring Committee’s ability to effectively address their mission.  \nKeywords  \nIndependence, mission, indemnification, confidentiality, mediator  \nIntroduction: the mission of the Data Monitoring Committee and an overview of Data Monitoring Committee best practices  \nThe mission of Data Monitoring Committees (DMCs) is to safeguard the interests of study participants and to enhance the integrity and credibility of clinical trials. Of considerable importance to the DMC’s ability to achieve this mission are best practices that include maintaining confidentiality of emerging data and ensuring the independence of DMCs from sponsorsand investigators.1–6  \nAn earlier article provided in-depth consideration of DMC best practices and operating principles to enhance their independence and effectiveness.1 That article addressed the importance of better training opportunities for DMC members, approaches to  \nprotect DMC members against legal liability arising from their service, avoiding DMC Charters that specify overly rigid procedures rather than principles to guide the DMC process, developing DMC recommendations through a consensus rather than voting process, structuring DMC meetings in a way that maintains the independence of the DMC and clearly establishes the leadership of the DMC chair, and ensuring that the independent statistical group that generates the reports  \n1 Department of Biostatistics, University of Washington, Seattle, WA, USA  \n2University of Pennsylvania, Philadelphia, PA, USA 3Universit","cbCaipUx8vgAETEN","https://ap.wps.com/l/cbCaipUx8vgAETEN","pdf",109607,8,"English","# Introduction\n## The mission of the Data Monitoring Committee and overview of best practices\n# Confidentiality issues\n## Overview\n# Abstract\n## Key recommendations","[{\"question\":\"In what rare situations might a mediator be useful according to the document?\",\"answer\":\"A mediator could be useful when the DMC has serious ethical or scientific concerns about the sponsor’s dissemination or lack of dissemination of information.\"}]","Data Monitoring Committees: Current issues - Abstract and key best practices for confidentiality and independence | PDF",1789584619]