Using a single noninferiority margin or preserved fraction for an entire pharmacological class was found to be inappropriate

Objective: To assess the impact on noninferiority decisions when using a single margin or single preserved fraction (PF) for all noninferiority trials within a pharmacological class.Study Design and Setting: A search in PubMed, EMBASE, and CENTRAL resulted in seven active-controlled statin trials (n...
Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Althunian, Turki A. [verfasserIn] de Boer, Anthonius [verfasserIn] Groenwold, Rolf H.H. [verfasserIn] Klungel, Olaf H. [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2018

Schlagwörter:	Methodology Noninferiority Drug regulation Clinical trials Biostatistics Randomized controlled trials

Übergeordnetes Werk:	Enthalten in: Journal of clinical epidemiology - Amsterdam [u.a.] : Elsevier Science, 1988, 104, Seite 15-23
Übergeordnetes Werk:	volume:104 ; pages:15-23

DOI / URN:	10.1016/j.jclinepi.2018.07.004

Katalog-ID:	ELV001026151

Internformat


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245	1	0	\|a Using a single noninferiority margin or preserved fraction for an entire pharmacological class was found to be inappropriate
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520			\|a Objective: To assess the impact on noninferiority decisions when using a single margin or single preserved fraction (PF) for all noninferiority trials within a pharmacological class.Study Design and Setting: A search in PubMed, EMBASE, and CENTRAL resulted in seven active-controlled statin trials (nine noninferiority comparisons) for treating hyperlipidemia. The impact of using a single margin was assessed by calculating whether this margin corresponds to different PFs among comparator statins which will demonstrate that the threshold of demonstrating noninferiority (in terms of the PF) varies among comparator statins. The use of a single PF was assessed by reanalyzing noninferiority in the included trials with new margins (based on the single PF) for each comparator statin.Results: The use of a single margin resulted in PFs that range between 81% and 89% for the different comparators (i.e., different thresholds). The use of a single PF resulted in four of nine (44%) different noninferiority conclusions compared with the original analyses.Conclusion: The threshold of demonstrating noninferiority with a single margin or single PF of the effect per pharmacological class may not be consistent with using a margin/PF for each comparator separately and may impact the conclusions of noninferiority.
650		4	\|a Methodology
650		4	\|a Noninferiority
650		4	\|a Drug regulation
650		4	\|a Clinical trials
650		4	\|a Biostatistics
650		4	\|a Randomized controlled trials
700	1		\|a de Boer, Anthonius \|e verfasserin \|4 aut
700	1		\|a Groenwold, Rolf H.H. \|e verfasserin \|4 aut
700	1		\|a Klungel, Olaf H. \|e verfasserin \|4 aut
773	0	8	\|i Enthalten in \|t Journal of clinical epidemiology \|d Amsterdam [u.a.] : Elsevier Science, 1988 \|g 104, Seite 15-23 \|h Online-Ressource \|w (DE-627)306659700 \|w (DE-600)1500490-9 \|w (DE-576)081986343 \|x 1878-5921 \|7 nnns
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912			\|a GBV_ILN_31
912			\|a GBV_ILN_32
912			\|a GBV_ILN_40
912			\|a GBV_ILN_60
912			\|a GBV_ILN_62
912			\|a GBV_ILN_63
912			\|a GBV_ILN_65
912			\|a GBV_ILN_69
912			\|a GBV_ILN_70
912			\|a GBV_ILN_73
912			\|a GBV_ILN_74
912			\|a GBV_ILN_90
912			\|a GBV_ILN_95
912			\|a GBV_ILN_100
912			\|a GBV_ILN_101
912			\|a GBV_ILN_105
912			\|a GBV_ILN_110
912			\|a GBV_ILN_151
912			\|a GBV_ILN_224
912			\|a GBV_ILN_370
912			\|a GBV_ILN_602
912			\|a GBV_ILN_702
912			\|a GBV_ILN_2003
912			\|a GBV_ILN_2004
912			\|a GBV_ILN_2005
912			\|a GBV_ILN_2011
912			\|a GBV_ILN_2014
912			\|a GBV_ILN_2015
912			\|a GBV_ILN_2020
912			\|a GBV_ILN_2021
912			\|a GBV_ILN_2025
912			\|a GBV_ILN_2027
912			\|a GBV_ILN_2034
912			\|a GBV_ILN_2038
912			\|a GBV_ILN_2044
912			\|a GBV_ILN_2048
912			\|a GBV_ILN_2049
912			\|a GBV_ILN_2050
912			\|a GBV_ILN_2056
912			\|a GBV_ILN_2059
912			\|a GBV_ILN_2061
912			\|a GBV_ILN_2064
912			\|a GBV_ILN_2065
912			\|a GBV_ILN_2068
912			\|a GBV_ILN_2111
912			\|a GBV_ILN_2112
912			\|a GBV_ILN_2113
912			\|a GBV_ILN_2118
912			\|a GBV_ILN_2122
912			\|a GBV_ILN_2129
912			\|a GBV_ILN_2143
912			\|a GBV_ILN_2147
912			\|a GBV_ILN_2148
912			\|a GBV_ILN_2152
912			\|a GBV_ILN_2153
912			\|a GBV_ILN_2190
912			\|a GBV_ILN_2336
912			\|a GBV_ILN_2507
912			\|a GBV_ILN_2522
912			\|a GBV_ILN_4035
912			\|a GBV_ILN_4037
912			\|a GBV_ILN_4112
912			\|a GBV_ILN_4125
912			\|a GBV_ILN_4126
912			\|a GBV_ILN_4242
912			\|a GBV_ILN_4251
912			\|a GBV_ILN_4305
912			\|a GBV_ILN_4313
912			\|a GBV_ILN_4323
912			\|a GBV_ILN_4324
912			\|a GBV_ILN_4325
912			\|a GBV_ILN_4326
912			\|a GBV_ILN_4333
912			\|a GBV_ILN_4334
912			\|a GBV_ILN_4335
912			\|a GBV_ILN_4338
912			\|a GBV_ILN_4393
936	b	k	\|a 44.11 \|j Präventivmedizin
936	b	k	\|a 44.40 \|j Pharmazie \|j Pharmazeutika
951			\|a AR
952			\|d 104 \|h 15-23

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author_variant	t a a ta taa b a d ba bad r h g rh rhg o h k oh ohk
matchkey_str	article:18785921:2018----::snaigeoifroiyagnrrsrefatofrnniehraooiac
hierarchy_sort_str	2018
bklnumber	44.11 44.40
publishDate	2018
allfields	10.1016/j.jclinepi.2018.07.004 doi (DE-627)ELV001026151 (ELSEVIER)S0895-4356(17)31294-5 DE-627 ger DE-627 rda eng 610 DE-600 PHARM DE-84 fid 44.11 bkl 44.40 bkl Althunian, Turki A. verfasserin aut Using a single noninferiority margin or preserved fraction for an entire pharmacological class was found to be inappropriate 2018 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objective: To assess the impact on noninferiority decisions when using a single margin or single preserved fraction (PF) for all noninferiority trials within a pharmacological class.Study Design and Setting: A search in PubMed, EMBASE, and CENTRAL resulted in seven active-controlled statin trials (nine noninferiority comparisons) for treating hyperlipidemia. The impact of using a single margin was assessed by calculating whether this margin corresponds to different PFs among comparator statins which will demonstrate that the threshold of demonstrating noninferiority (in terms of the PF) varies among comparator statins. The use of a single PF was assessed by reanalyzing noninferiority in the included trials with new margins (based on the single PF) for each comparator statin.Results: The use of a single margin resulted in PFs that range between 81% and 89% for the different comparators (i.e., different thresholds). The use of a single PF resulted in four of nine (44%) different noninferiority conclusions compared with the original analyses.Conclusion: The threshold of demonstrating noninferiority with a single margin or single PF of the effect per pharmacological class may not be consistent with using a margin/PF for each comparator separately and may impact the conclusions of noninferiority. Methodology Noninferiority Drug regulation Clinical trials Biostatistics Randomized controlled trials de Boer, Anthonius verfasserin aut Groenwold, Rolf H.H. verfasserin aut Klungel, Olaf H. verfasserin aut Enthalten in Journal of clinical epidemiology Amsterdam [u.a.] : Elsevier Science, 1988 104, Seite 15-23 Online-Ressource (DE-627)306659700 (DE-600)1500490-9 (DE-576)081986343 1878-5921 nnns volume:104 pages:15-23 GBV_USEFLAG_U SYSFLAG_U GBV_ELV FID-PHARM SSG-OLC-PHA SSG-OPC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.11 Präventivmedizin 44.40 Pharmazie Pharmazeutika AR 104 15-23
spelling	10.1016/j.jclinepi.2018.07.004 doi (DE-627)ELV001026151 (ELSEVIER)S0895-4356(17)31294-5 DE-627 ger DE-627 rda eng 610 DE-600 PHARM DE-84 fid 44.11 bkl 44.40 bkl Althunian, Turki A. verfasserin aut Using a single noninferiority margin or preserved fraction for an entire pharmacological class was found to be inappropriate 2018 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objective: To assess the impact on noninferiority decisions when using a single margin or single preserved fraction (PF) for all noninferiority trials within a pharmacological class.Study Design and Setting: A search in PubMed, EMBASE, and CENTRAL resulted in seven active-controlled statin trials (nine noninferiority comparisons) for treating hyperlipidemia. The impact of using a single margin was assessed by calculating whether this margin corresponds to different PFs among comparator statins which will demonstrate that the threshold of demonstrating noninferiority (in terms of the PF) varies among comparator statins. The use of a single PF was assessed by reanalyzing noninferiority in the included trials with new margins (based on the single PF) for each comparator statin.Results: The use of a single margin resulted in PFs that range between 81% and 89% for the different comparators (i.e., different thresholds). The use of a single PF resulted in four of nine (44%) different noninferiority conclusions compared with the original analyses.Conclusion: The threshold of demonstrating noninferiority with a single margin or single PF of the effect per pharmacological class may not be consistent with using a margin/PF for each comparator separately and may impact the conclusions of noninferiority. Methodology Noninferiority Drug regulation Clinical trials Biostatistics Randomized controlled trials de Boer, Anthonius verfasserin aut Groenwold, Rolf H.H. verfasserin aut Klungel, Olaf H. verfasserin aut Enthalten in Journal of clinical epidemiology Amsterdam [u.a.] : Elsevier Science, 1988 104, Seite 15-23 Online-Ressource (DE-627)306659700 (DE-600)1500490-9 (DE-576)081986343 1878-5921 nnns volume:104 pages:15-23 GBV_USEFLAG_U SYSFLAG_U GBV_ELV FID-PHARM SSG-OLC-PHA SSG-OPC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.11 Präventivmedizin 44.40 Pharmazie Pharmazeutika AR 104 15-23
allfields_unstemmed	10.1016/j.jclinepi.2018.07.004 doi (DE-627)ELV001026151 (ELSEVIER)S0895-4356(17)31294-5 DE-627 ger DE-627 rda eng 610 DE-600 PHARM DE-84 fid 44.11 bkl 44.40 bkl Althunian, Turki A. verfasserin aut Using a single noninferiority margin or preserved fraction for an entire pharmacological class was found to be inappropriate 2018 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objective: To assess the impact on noninferiority decisions when using a single margin or single preserved fraction (PF) for all noninferiority trials within a pharmacological class.Study Design and Setting: A search in PubMed, EMBASE, and CENTRAL resulted in seven active-controlled statin trials (nine noninferiority comparisons) for treating hyperlipidemia. The impact of using a single margin was assessed by calculating whether this margin corresponds to different PFs among comparator statins which will demonstrate that the threshold of demonstrating noninferiority (in terms of the PF) varies among comparator statins. The use of a single PF was assessed by reanalyzing noninferiority in the included trials with new margins (based on the single PF) for each comparator statin.Results: The use of a single margin resulted in PFs that range between 81% and 89% for the different comparators (i.e., different thresholds). The use of a single PF resulted in four of nine (44%) different noninferiority conclusions compared with the original analyses.Conclusion: The threshold of demonstrating noninferiority with a single margin or single PF of the effect per pharmacological class may not be consistent with using a margin/PF for each comparator separately and may impact the conclusions of noninferiority. Methodology Noninferiority Drug regulation Clinical trials Biostatistics Randomized controlled trials de Boer, Anthonius verfasserin aut Groenwold, Rolf H.H. verfasserin aut Klungel, Olaf H. verfasserin aut Enthalten in Journal of clinical epidemiology Amsterdam [u.a.] : Elsevier Science, 1988 104, Seite 15-23 Online-Ressource (DE-627)306659700 (DE-600)1500490-9 (DE-576)081986343 1878-5921 nnns volume:104 pages:15-23 GBV_USEFLAG_U SYSFLAG_U GBV_ELV FID-PHARM SSG-OLC-PHA SSG-OPC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.11 Präventivmedizin 44.40 Pharmazie Pharmazeutika AR 104 15-23
allfieldsGer	10.1016/j.jclinepi.2018.07.004 doi (DE-627)ELV001026151 (ELSEVIER)S0895-4356(17)31294-5 DE-627 ger DE-627 rda eng 610 DE-600 PHARM DE-84 fid 44.11 bkl 44.40 bkl Althunian, Turki A. verfasserin aut Using a single noninferiority margin or preserved fraction for an entire pharmacological class was found to be inappropriate 2018 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objective: To assess the impact on noninferiority decisions when using a single margin or single preserved fraction (PF) for all noninferiority trials within a pharmacological class.Study Design and Setting: A search in PubMed, EMBASE, and CENTRAL resulted in seven active-controlled statin trials (nine noninferiority comparisons) for treating hyperlipidemia. The impact of using a single margin was assessed by calculating whether this margin corresponds to different PFs among comparator statins which will demonstrate that the threshold of demonstrating noninferiority (in terms of the PF) varies among comparator statins. The use of a single PF was assessed by reanalyzing noninferiority in the included trials with new margins (based on the single PF) for each comparator statin.Results: The use of a single margin resulted in PFs that range between 81% and 89% for the different comparators (i.e., different thresholds). The use of a single PF resulted in four of nine (44%) different noninferiority conclusions compared with the original analyses.Conclusion: The threshold of demonstrating noninferiority with a single margin or single PF of the effect per pharmacological class may not be consistent with using a margin/PF for each comparator separately and may impact the conclusions of noninferiority. Methodology Noninferiority Drug regulation Clinical trials Biostatistics Randomized controlled trials de Boer, Anthonius verfasserin aut Groenwold, Rolf H.H. verfasserin aut Klungel, Olaf H. verfasserin aut Enthalten in Journal of clinical epidemiology Amsterdam [u.a.] : Elsevier Science, 1988 104, Seite 15-23 Online-Ressource (DE-627)306659700 (DE-600)1500490-9 (DE-576)081986343 1878-5921 nnns volume:104 pages:15-23 GBV_USEFLAG_U SYSFLAG_U GBV_ELV FID-PHARM SSG-OLC-PHA SSG-OPC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.11 Präventivmedizin 44.40 Pharmazie Pharmazeutika AR 104 15-23
allfieldsSound	10.1016/j.jclinepi.2018.07.004 doi (DE-627)ELV001026151 (ELSEVIER)S0895-4356(17)31294-5 DE-627 ger DE-627 rda eng 610 DE-600 PHARM DE-84 fid 44.11 bkl 44.40 bkl Althunian, Turki A. verfasserin aut Using a single noninferiority margin or preserved fraction for an entire pharmacological class was found to be inappropriate 2018 nicht spezifiziert zzz rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Objective: To assess the impact on noninferiority decisions when using a single margin or single preserved fraction (PF) for all noninferiority trials within a pharmacological class.Study Design and Setting: A search in PubMed, EMBASE, and CENTRAL resulted in seven active-controlled statin trials (nine noninferiority comparisons) for treating hyperlipidemia. The impact of using a single margin was assessed by calculating whether this margin corresponds to different PFs among comparator statins which will demonstrate that the threshold of demonstrating noninferiority (in terms of the PF) varies among comparator statins. The use of a single PF was assessed by reanalyzing noninferiority in the included trials with new margins (based on the single PF) for each comparator statin.Results: The use of a single margin resulted in PFs that range between 81% and 89% for the different comparators (i.e., different thresholds). The use of a single PF resulted in four of nine (44%) different noninferiority conclusions compared with the original analyses.Conclusion: The threshold of demonstrating noninferiority with a single margin or single PF of the effect per pharmacological class may not be consistent with using a margin/PF for each comparator separately and may impact the conclusions of noninferiority. Methodology Noninferiority Drug regulation Clinical trials Biostatistics Randomized controlled trials de Boer, Anthonius verfasserin aut Groenwold, Rolf H.H. verfasserin aut Klungel, Olaf H. verfasserin aut Enthalten in Journal of clinical epidemiology Amsterdam [u.a.] : Elsevier Science, 1988 104, Seite 15-23 Online-Ressource (DE-627)306659700 (DE-600)1500490-9 (DE-576)081986343 1878-5921 nnns volume:104 pages:15-23 GBV_USEFLAG_U SYSFLAG_U GBV_ELV FID-PHARM SSG-OLC-PHA SSG-OPC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_224 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2056 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4313 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4338 GBV_ILN_4393 44.11 Präventivmedizin 44.40 Pharmazie Pharmazeutika AR 104 15-23
language	English
source	Enthalten in Journal of clinical epidemiology 104, Seite 15-23 volume:104 pages:15-23
sourceStr	Enthalten in Journal of clinical epidemiology 104, Seite 15-23 volume:104 pages:15-23
format_phy_str_mv	Article
bklname	Präventivmedizin Pharmazie Pharmazeutika
institution	findex.gbv.de
topic_facet	Methodology Noninferiority Drug regulation Clinical trials Biostatistics Randomized controlled trials
dewey-raw	610
isfreeaccess_bool	false
container_title	Journal of clinical epidemiology
authorswithroles_txt_mv	Althunian, Turki A. @@aut@@ de Boer, Anthonius @@aut@@ Groenwold, Rolf H.H. @@aut@@ Klungel, Olaf H. @@aut@@
publishDateDaySort_date	2018-01-01T00:00:00Z
hierarchy_top_id	306659700
dewey-sort	3610
id	ELV001026151
language_de	englisch
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author	Althunian, Turki A.
spellingShingle	Althunian, Turki A. ddc 610 fid PHARM bkl 44.11 bkl 44.40 misc Methodology misc Noninferiority misc Drug regulation misc Clinical trials misc Biostatistics misc Randomized controlled trials Using a single noninferiority margin or preserved fraction for an entire pharmacological class was found to be inappropriate
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topic_title	610 DE-600 PHARM DE-84 fid 44.11 bkl 44.40 bkl Using a single noninferiority margin or preserved fraction for an entire pharmacological class was found to be inappropriate Methodology Noninferiority Drug regulation Clinical trials Biostatistics Randomized controlled trials
topic	ddc 610 fid PHARM bkl 44.11 bkl 44.40 misc Methodology misc Noninferiority misc Drug regulation misc Clinical trials misc Biostatistics misc Randomized controlled trials
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title	Using a single noninferiority margin or preserved fraction for an entire pharmacological class was found to be inappropriate
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title_full	Using a single noninferiority margin or preserved fraction for an entire pharmacological class was found to be inappropriate
author_sort	Althunian, Turki A.
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dewey-full	610
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title_sort	using a single noninferiority margin or preserved fraction for an entire pharmacological class was found to be inappropriate
title_auth	Using a single noninferiority margin or preserved fraction for an entire pharmacological class was found to be inappropriate
abstract	Objective: To assess the impact on noninferiority decisions when using a single margin or single preserved fraction (PF) for all noninferiority trials within a pharmacological class.Study Design and Setting: A search in PubMed, EMBASE, and CENTRAL resulted in seven active-controlled statin trials (nine noninferiority comparisons) for treating hyperlipidemia. The impact of using a single margin was assessed by calculating whether this margin corresponds to different PFs among comparator statins which will demonstrate that the threshold of demonstrating noninferiority (in terms of the PF) varies among comparator statins. The use of a single PF was assessed by reanalyzing noninferiority in the included trials with new margins (based on the single PF) for each comparator statin.Results: The use of a single margin resulted in PFs that range between 81% and 89% for the different comparators (i.e., different thresholds). The use of a single PF resulted in four of nine (44%) different noninferiority conclusions compared with the original analyses.Conclusion: The threshold of demonstrating noninferiority with a single margin or single PF of the effect per pharmacological class may not be consistent with using a margin/PF for each comparator separately and may impact the conclusions of noninferiority.
abstractGer	Objective: To assess the impact on noninferiority decisions when using a single margin or single preserved fraction (PF) for all noninferiority trials within a pharmacological class.Study Design and Setting: A search in PubMed, EMBASE, and CENTRAL resulted in seven active-controlled statin trials (nine noninferiority comparisons) for treating hyperlipidemia. The impact of using a single margin was assessed by calculating whether this margin corresponds to different PFs among comparator statins which will demonstrate that the threshold of demonstrating noninferiority (in terms of the PF) varies among comparator statins. The use of a single PF was assessed by reanalyzing noninferiority in the included trials with new margins (based on the single PF) for each comparator statin.Results: The use of a single margin resulted in PFs that range between 81% and 89% for the different comparators (i.e., different thresholds). The use of a single PF resulted in four of nine (44%) different noninferiority conclusions compared with the original analyses.Conclusion: The threshold of demonstrating noninferiority with a single margin or single PF of the effect per pharmacological class may not be consistent with using a margin/PF for each comparator separately and may impact the conclusions of noninferiority.
abstract_unstemmed	Objective: To assess the impact on noninferiority decisions when using a single margin or single preserved fraction (PF) for all noninferiority trials within a pharmacological class.Study Design and Setting: A search in PubMed, EMBASE, and CENTRAL resulted in seven active-controlled statin trials (nine noninferiority comparisons) for treating hyperlipidemia. The impact of using a single margin was assessed by calculating whether this margin corresponds to different PFs among comparator statins which will demonstrate that the threshold of demonstrating noninferiority (in terms of the PF) varies among comparator statins. The use of a single PF was assessed by reanalyzing noninferiority in the included trials with new margins (based on the single PF) for each comparator statin.Results: The use of a single margin resulted in PFs that range between 81% and 89% for the different comparators (i.e., different thresholds). The use of a single PF resulted in four of nine (44%) different noninferiority conclusions compared with the original analyses.Conclusion: The threshold of demonstrating noninferiority with a single margin or single PF of the effect per pharmacological class may not be consistent with using a margin/PF for each comparator separately and may impact the conclusions of noninferiority.
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title_short	Using a single noninferiority margin or preserved fraction for an entire pharmacological class was found to be inappropriate
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up_date	2024-07-06T19:58:34.530Z
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score	7.401469

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Using a single noninferiority margin or preserved fraction for an entire pharmacological class was found to be inappropriate

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