{"id":276,"date":"2020-03-26T23:17:51","date_gmt":"2020-03-26T22:17:51","guid":{"rendered":"http:\/\/re.clinicalresearch.at\/?p=276"},"modified":"2020-03-26T23:17:51","modified_gmt":"2020-03-26T22:17:51","slug":"data-safety-monitoring-board-independent-board-for-patient-safety","status":"publish","type":"post","link":"https:\/\/clinicalresearch.at\/en\/data-safety-monitoring-board-independent-board-for-patient-safety\/","title":{"rendered":"DATA SAFETY MONITORING BOARD- INDEPENDENT BOARD FOR PATIENT SAFETY"},"content":{"rendered":"<p>Should a complex clinical trial be stopped, i.e. due to the accumulation of unexpected serious adverse reactions, or even missing or surpassing effectivity of the medicine? These are some of the questions the Data Safety Monitoring Board, shortly known as DSMB or DCM (Data Monitoring Committee) has to decide upon.<\/p>\n<p>The institution of a DSMB is recommended in clinical trials concerning especially life- threatening indications, concerning long-term therapies or those therapies with substances that yield more or graver side effects; above all a DSMB is strongly recommended when groups of patients are concerned that are subject to more restrictive legal or ethical concerns and\/or protection.<\/p>\n<p>The DSMB is an independent committee, consisting of experienced medical personnel, which has expertise in biostatic as well as basic ethical questions. They review the documentation of interim analyses and decide about questions of patient security, risk \u2013benefit analysis and effectiveness of the substance.<\/p>\n<p>The DSMB is only eligible to give advice to the sponsor \u2013 the responsibility for the trial always rests with the sponsor.<\/p>\n<p>(Weidenthaler, Dr. Heinz, \u201cData Safety Monitoring Board-unabh\u00e4ngige Instanz f\u00fcr die Patientensicherheit\u201c\u201d published in Pharmazeutische Medizin 2011 Heft 3, Jahrgang 13; excerpt)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Should a complex clinical trial be stopped, i.e. due to the accumulation of unexpected serious adverse reactions, or even missing or surpassing effectivity of the medicine? These are some of the questions the Data Safety Monitoring Board, shortly known as DSMB or DCM (Data Monitoring Committee) has to decide upon. The institution of a DSMB&hellip;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[20],"tags":[],"class_list":["post-276","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>DATA SAFETY MONITORING BOARD- INDEPENDENT BOARD FOR PATIENT SAFETY - Clinical Research Services<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/clinicalresearch.at\/en\/data-safety-monitoring-board-independent-board-for-patient-safety\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"DATA SAFETY MONITORING BOARD- INDEPENDENT BOARD FOR PATIENT SAFETY - Clinical Research Services\" \/>\n<meta property=\"og:description\" content=\"Should a complex clinical trial be stopped, i.e. due to the accumulation of unexpected serious adverse reactions, or even missing or surpassing effectivity of the medicine? 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