Multiplicity in confirmatory clinical trials: a case study with discussion from a JSM panel
An invited panel session was conducted in the 2012 Joint Statistical Meetings, San Diego, California, USA, to stimulate the discussion on multiplicity issues in confirmatory clinical trials for drug development. A total of 11 expert panel members were invited and 9 participated. Prior to the session...
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| Veröffentlicht in: | Statistics in medicine 2015-11, Vol.34 (26), p.3461-3480 |
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| container_title | Statistics in medicine |
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| creator | Wang, Sue-Jane Bretz, Frank Dmitrienko, Alex Hsu, Jason Hung, H. M. James Koch, Gary Maurer, Willi Offen, Walt O'Neill, Robert |
| description | An invited panel session was conducted in the 2012 Joint Statistical Meetings, San Diego, California, USA, to stimulate the discussion on multiplicity issues in confirmatory clinical trials for drug development. A total of 11 expert panel members were invited and 9 participated. Prior to the session, a case study was previously provided to the panel members to facilitate the discussion, focusing on the key components of the study design and multiplicity. The Phase 3 development program for this new experimental treatment was based on a single randomized controlled trial alone. Each panelist was asked to clarify if he or she responded as if he or she were a pharmaceutical drug sponsor, an academic panelist or a health regulatory scientist. Copyright © 2015 John Wiley & Sons, Ltd. |
| doi_str_mv | 10.1002/sim.6561 |
| format | Article |
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Each panelist was asked to clarify if he or she responded as if he or she were a pharmaceutical drug sponsor, an academic panelist or a health regulatory scientist. 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M. James</creatorcontrib><creatorcontrib>Koch, Gary</creatorcontrib><creatorcontrib>Maurer, Willi</creatorcontrib><creatorcontrib>Offen, Walt</creatorcontrib><creatorcontrib>O'Neill, Robert</creatorcontrib><title>Multiplicity in confirmatory clinical trials: a case study with discussion from a JSM panel</title><title>Statistics in medicine</title><addtitle>Statist. Med</addtitle><description>An invited panel session was conducted in the 2012 Joint Statistical Meetings, San Diego, California, USA, to stimulate the discussion on multiplicity issues in confirmatory clinical trials for drug development. A total of 11 expert panel members were invited and 9 participated. Prior to the session, a case study was previously provided to the panel members to facilitate the discussion, focusing on the key components of the study design and multiplicity. The Phase 3 development program for this new experimental treatment was based on a single randomized controlled trial alone. Each panelist was asked to clarify if he or she responded as if he or she were a pharmaceutical drug sponsor, an academic panelist or a health regulatory scientist. Copyright © 2015 John Wiley & Sons, Ltd.</description><subject>accelerated approval</subject><subject>biomarker endpoint</subject><subject>Clinical trials</subject><subject>Clinical Trials, Phase III as Topic - statistics & numerical data</subject><subject>Congresses as Topic</subject><subject>Data Interpretation, Statistical</subject><subject>decision theoretic</subject><subject>Drug Discovery - statistics & numerical data</subject><subject>Endpoint Determination - methods</subject><subject>Humans</subject><subject>Infant, Newborn</subject><subject>Medical treatment</subject><subject>multiplicity in regions</subject><subject>primary and key secondary endpoints</subject><subject>R&D</subject><subject>Research & development</subject><subject>Research Design - statistics & numerical data</subject><subject>Respiratory Distress Syndrome, Newborn - drug therapy</subject><subject>Treatment Outcome</subject><issn>0277-6715</issn><issn>1097-0258</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp10M1r2zAYBnBRVpqsG-wvKIJddnGqVx9WvNsIWz9IWmgzdthByLJM1cp2Ktl0_u-n0DSFQk_v5fc-PDwIfQEyA0LoaXTNLBc5HKApkEJmhIr5BzQlVMoslyAm6GOM94QACCqP0ITmAJTNYYr-rgbfu413xvUjdi02XVu70Oi-CyM23rXOaI_74LSP37HGRkeLYz9UI35y_R2uXDRDjK5rcR26JonL2xXe6Nb6T-iwTl_28-4eo9-_fq4X59ny-uxi8WOZGS4kZFTQWpS24HVel6XhuSZGz01RcJDMCOCpqi1FrivCbWltxUkBFLTRpODMAjtG355zN6F7HGzsVZNKWe9TiW6ICiQlXEDBtvTrG3rfDaFN7bYKJOFzzl8DTehiDLZWm-AaHUYFRG0HV2lwtR080ZNd4FA2ttrDl4UTyJ7Bk_N2fDdI3V6sdoE772Jv_-29Dg8ql0wK9efqTDFYSEbXN2rJ_gPewJfm</recordid><startdate>20151120</startdate><enddate>20151120</enddate><creator>Wang, Sue-Jane</creator><creator>Bretz, Frank</creator><creator>Dmitrienko, Alex</creator><creator>Hsu, Jason</creator><creator>Hung, H. 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| ispartof | Statistics in medicine, 2015-11, Vol.34 (26), p.3461-3480 |
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| language | eng |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | accelerated approval biomarker endpoint Clinical trials Clinical Trials, Phase III as Topic - statistics & numerical data Congresses as Topic Data Interpretation, Statistical decision theoretic Drug Discovery - statistics & numerical data Endpoint Determination - methods Humans Infant, Newborn Medical treatment multiplicity in regions primary and key secondary endpoints R&D Research & development Research Design - statistics & numerical data Respiratory Distress Syndrome, Newborn - drug therapy Treatment Outcome |
| title | Multiplicity in confirmatory clinical trials: a case study with discussion from a JSM panel |
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