The age of randomized clinical trials: three important aspects of randomized clinical trials in cardiovascular pharmacotherapy with examples from lipid, diabetes, and antithrombotic trials
Abstract This review article aims to explain the important issues that data safety monitoring boards (DSMB) face when considering early termination of a trial and is specifically addressed to the needs of clinical and research cardiologists. We give an insight into the overall background and then fo...
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Veröffentlicht in: | European heart journal. Cardiovascular pharmacotherapy 2021-09, Vol.7 (5), p.453-459 |
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container_title | European heart journal. Cardiovascular pharmacotherapy |
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creator | Drexel, Heinz Lewis, Basil S Rosano, Giuseppe M C Saely, Christoph H Tautermann, Gerda Huber, Kurt Dopheide, Joern F Kaski, Juan Carlos Mader, Arthur Niessner, Alexander Savarese, Gianluigi Schmidt, Thomas A Semb, AnneGrete Tamargo, Juan Wassmann, Sven Per Kjeldsen, Keld Agewall, Stefan Pocock, Stuart J |
description | Abstract
This review article aims to explain the important issues that data safety monitoring boards (DSMB) face when considering early termination of a trial and is specifically addressed to the needs of clinical and research cardiologists. We give an insight into the overall background and then focus on the three principal reasons for stopping trials, i.e. efficacy, futility, and harm. The statistical essentials are also addressed to familiarize clinicians with the key principles. The topic is further highlighted by numerous examples from lipid trials and antithrombotic trials. This is followed by an overview of regulatory aspects, including an insight into industry–investigator interactions. To conclude, we summarize the key elements that are the basis for a decision to stop a randomized clinical trial (RCT). |
doi_str_mv | 10.1093/ehjcvp/pvaa126 |
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This review article aims to explain the important issues that data safety monitoring boards (DSMB) face when considering early termination of a trial and is specifically addressed to the needs of clinical and research cardiologists. We give an insight into the overall background and then focus on the three principal reasons for stopping trials, i.e. efficacy, futility, and harm. The statistical essentials are also addressed to familiarize clinicians with the key principles. The topic is further highlighted by numerous examples from lipid trials and antithrombotic trials. This is followed by an overview of regulatory aspects, including an insight into industry–investigator interactions. To conclude, we summarize the key elements that are the basis for a decision to stop a randomized clinical trial (RCT).</description><identifier>ISSN: 2055-6837</identifier><identifier>ISSN: 2055-6845</identifier><identifier>EISSN: 2055-6845</identifier><identifier>DOI: 10.1093/ehjcvp/pvaa126</identifier><identifier>PMID: 33135079</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Apixaban ; Cardiovascular disease ; Clinical trials ; Diabetes ; Diabetes Mellitus - diagnosis ; Diabetes Mellitus - drug therapy ; Drug therapy ; Evidence-based medicine ; Fibrinolytic Agents - adverse effects ; Humans ; Laropiprant ; Lipids ; Medicin och hälsovetenskap ; Randomized Controlled Trials as Topic ; Research Design ; Rivaroxaban ; Thrombosis</subject><ispartof>European heart journal. Cardiovascular pharmacotherapy, 2021-09, Vol.7 (5), p.453-459</ispartof><rights>Published on behalf of the European Society of Cardiology. © The Author(s) 2020. 2020</rights><rights>Published on behalf of the European Society of Cardiology. © The Author(s) 2020.</rights><rights>COPYRIGHT 2021 Oxford University Press</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5538-fa49d430a34061b0c1dc6e22d7b8f7e4419c505c040623ae58b8286615faa6863</citedby><cites>FETCH-LOGICAL-c5538-fa49d430a34061b0c1dc6e22d7b8f7e4419c505c040623ae58b8286615faa6863</cites><orcidid>0000-0003-2212-4007 ; 0000-0002-6942-6312 ; 0000-0002-4677-9756</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,552,780,784,885,1584,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33135079$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:147755541$$DView record from Swedish Publication Index$$Hfree_for_read</backlink><backlink>$$Uhttp://kipublications.ki.se/Default.aspx?queryparsed=id:148798233$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><creatorcontrib>Drexel, Heinz</creatorcontrib><creatorcontrib>Lewis, Basil S</creatorcontrib><creatorcontrib>Rosano, Giuseppe M C</creatorcontrib><creatorcontrib>Saely, Christoph H</creatorcontrib><creatorcontrib>Tautermann, Gerda</creatorcontrib><creatorcontrib>Huber, Kurt</creatorcontrib><creatorcontrib>Dopheide, Joern F</creatorcontrib><creatorcontrib>Kaski, Juan Carlos</creatorcontrib><creatorcontrib>Mader, Arthur</creatorcontrib><creatorcontrib>Niessner, Alexander</creatorcontrib><creatorcontrib>Savarese, Gianluigi</creatorcontrib><creatorcontrib>Schmidt, Thomas A</creatorcontrib><creatorcontrib>Semb, AnneGrete</creatorcontrib><creatorcontrib>Tamargo, Juan</creatorcontrib><creatorcontrib>Wassmann, Sven</creatorcontrib><creatorcontrib>Per Kjeldsen, Keld</creatorcontrib><creatorcontrib>Agewall, Stefan</creatorcontrib><creatorcontrib>Pocock, Stuart J</creatorcontrib><title>The age of randomized clinical trials: three important aspects of randomized clinical trials in cardiovascular pharmacotherapy with examples from lipid, diabetes, and antithrombotic trials</title><title>European heart journal. Cardiovascular pharmacotherapy</title><addtitle>Eur Heart J Cardiovasc Pharmacother</addtitle><description>Abstract
This review article aims to explain the important issues that data safety monitoring boards (DSMB) face when considering early termination of a trial and is specifically addressed to the needs of clinical and research cardiologists. We give an insight into the overall background and then focus on the three principal reasons for stopping trials, i.e. efficacy, futility, and harm. The statistical essentials are also addressed to familiarize clinicians with the key principles. The topic is further highlighted by numerous examples from lipid trials and antithrombotic trials. This is followed by an overview of regulatory aspects, including an insight into industry–investigator interactions. To conclude, we summarize the key elements that are the basis for a decision to stop a randomized clinical trial (RCT).</description><subject>Apixaban</subject><subject>Cardiovascular disease</subject><subject>Clinical trials</subject><subject>Diabetes</subject><subject>Diabetes Mellitus - diagnosis</subject><subject>Diabetes Mellitus - drug therapy</subject><subject>Drug therapy</subject><subject>Evidence-based medicine</subject><subject>Fibrinolytic Agents - adverse effects</subject><subject>Humans</subject><subject>Laropiprant</subject><subject>Lipids</subject><subject>Medicin och hälsovetenskap</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Research Design</subject><subject>Rivaroxaban</subject><subject>Thrombosis</subject><issn>2055-6837</issn><issn>2055-6845</issn><issn>2055-6845</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>D8T</sourceid><recordid>eNqdkk1r3DAQhk1paEKSa49F0FMhm0jWl91bCP2CQC_p2YzlcaytbamSvGn62_rjqrKbzSVtoQgxw8zzvgzDFMVLRs8ZrfkFDmuz8Rd-A8BK9aw4KqmUK1UJ-Xyfc31YnMa4ppQyVamy4i-KQ84Zl1TXR8XPmwEJ3CJxPQkwd26yP7AjZrSzNTCSFCyM8S1JQ0AkdvIuJJgTgejRpPh3GbEzMRA66zYQzTJCIH6AMIFxacAA_p7c2TQQ_A6THzGSPriJjNbb7ox0FlpMGM9I9s8_ZTK3W5es2fmfFAd9Dni6i8fFl_fvbq4-rq4_f_h0dXm9MlLyatWDqDvBKXBBFWupYZ1RWJadbqteoxCsNpJKQ3O75ICyaquyUorJHiDvjB8Xq61vvEO_tI0PdoJw3ziwza70NWfYCKVqVme-_iPvg-seRQ9CJipdVyXn_6XVWkopWNa-3moz-G3BmJq1W8KcV9OUUmtRKSnVI3ULIzZ27l0KYCYbTXOpKZOiVlpn6vwJKr8OJ2vcjL3N9acEJrgYA_b70Rltfp9rsz3XZneuWfBqN-3STtjt8YfjzMCbLeAW_y-zXyly-4U</recordid><startdate>20210901</startdate><enddate>20210901</enddate><creator>Drexel, Heinz</creator><creator>Lewis, Basil S</creator><creator>Rosano, Giuseppe M C</creator><creator>Saely, Christoph H</creator><creator>Tautermann, Gerda</creator><creator>Huber, Kurt</creator><creator>Dopheide, Joern F</creator><creator>Kaski, Juan Carlos</creator><creator>Mader, Arthur</creator><creator>Niessner, Alexander</creator><creator>Savarese, Gianluigi</creator><creator>Schmidt, Thomas A</creator><creator>Semb, AnneGrete</creator><creator>Tamargo, Juan</creator><creator>Wassmann, Sven</creator><creator>Per Kjeldsen, Keld</creator><creator>Agewall, Stefan</creator><creator>Pocock, Stuart J</creator><general>Oxford University Press</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>ADTPV</scope><scope>AOWAS</scope><scope>D8T</scope><scope>ZZAVC</scope><orcidid>https://orcid.org/0000-0003-2212-4007</orcidid><orcidid>https://orcid.org/0000-0002-6942-6312</orcidid><orcidid>https://orcid.org/0000-0002-4677-9756</orcidid></search><sort><creationdate>20210901</creationdate><title>The age of randomized clinical trials: three important aspects of randomized clinical trials in cardiovascular pharmacotherapy with examples from lipid, diabetes, and antithrombotic trials</title><author>Drexel, Heinz ; 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Cardiovascular pharmacotherapy</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Drexel, Heinz</au><au>Lewis, Basil S</au><au>Rosano, Giuseppe M C</au><au>Saely, Christoph H</au><au>Tautermann, Gerda</au><au>Huber, Kurt</au><au>Dopheide, Joern F</au><au>Kaski, Juan Carlos</au><au>Mader, Arthur</au><au>Niessner, Alexander</au><au>Savarese, Gianluigi</au><au>Schmidt, Thomas A</au><au>Semb, AnneGrete</au><au>Tamargo, Juan</au><au>Wassmann, Sven</au><au>Per Kjeldsen, Keld</au><au>Agewall, Stefan</au><au>Pocock, Stuart J</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>The age of randomized clinical trials: three important aspects of randomized clinical trials in cardiovascular pharmacotherapy with examples from lipid, diabetes, and antithrombotic trials</atitle><jtitle>European heart journal. Cardiovascular pharmacotherapy</jtitle><addtitle>Eur Heart J Cardiovasc Pharmacother</addtitle><date>2021-09-01</date><risdate>2021</risdate><volume>7</volume><issue>5</issue><spage>453</spage><epage>459</epage><pages>453-459</pages><issn>2055-6837</issn><issn>2055-6845</issn><eissn>2055-6845</eissn><abstract>Abstract
This review article aims to explain the important issues that data safety monitoring boards (DSMB) face when considering early termination of a trial and is specifically addressed to the needs of clinical and research cardiologists. We give an insight into the overall background and then focus on the three principal reasons for stopping trials, i.e. efficacy, futility, and harm. The statistical essentials are also addressed to familiarize clinicians with the key principles. The topic is further highlighted by numerous examples from lipid trials and antithrombotic trials. This is followed by an overview of regulatory aspects, including an insight into industry–investigator interactions. To conclude, we summarize the key elements that are the basis for a decision to stop a randomized clinical trial (RCT).</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>33135079</pmid><doi>10.1093/ehjcvp/pvaa126</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0003-2212-4007</orcidid><orcidid>https://orcid.org/0000-0002-6942-6312</orcidid><orcidid>https://orcid.org/0000-0002-4677-9756</orcidid><oa>free_for_read</oa></addata></record> |
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source | MEDLINE; SWEPUB Freely available online; Oxford University Press Journals All Titles (1996-Current); Alma/SFX Local Collection |
subjects | Apixaban Cardiovascular disease Clinical trials Diabetes Diabetes Mellitus - diagnosis Diabetes Mellitus - drug therapy Drug therapy Evidence-based medicine Fibrinolytic Agents - adverse effects Humans Laropiprant Lipids Medicin och hälsovetenskap Randomized Controlled Trials as Topic Research Design Rivaroxaban Thrombosis |
title | The age of randomized clinical trials: three important aspects of randomized clinical trials in cardiovascular pharmacotherapy with examples from lipid, diabetes, and antithrombotic trials |
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