Phase II Trials in Drug Development and Adaptive Trial Design
Summary: Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: <30% of drugs entering phase II studies fail to progress, and <58% of drugs go on to fail in phase III. Adaptive clinical trial design has been proposed as...
Ausführliche Beschreibung
Autor*in: |
Gail A. Van Norman, MD [verfasserIn] |
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Format: |
E-Artikel |
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Sprache: |
Englisch |
Erschienen: |
2019 |
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Übergeordnetes Werk: |
In: JACC: Basic to Translational Science - Elsevier, 2017, 4(2019), 3, Seite 428-437 |
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Übergeordnetes Werk: |
volume:4 ; year:2019 ; number:3 ; pages:428-437 |
Links: |
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DOI / URN: |
10.1016/j.jacbts.2019.02.005 |
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Katalog-ID: |
DOAJ023134658 |
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10.1016/j.jacbts.2019.02.005 doi (DE-627)DOAJ023134658 (DE-599)DOAJ23f6df0f77ac46e8b468a91a51e5ebb3 DE-627 ger DE-627 rakwb eng RC666-701 Gail A. Van Norman, MD verfasserin aut Phase II Trials in Drug Development and Adaptive Trial Design 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Summary: Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: <30% of drugs entering phase II studies fail to progress, and <58% of drugs go on to fail in phase III. Adaptive clinical trial design has been proposed as a way to reduce the costs of phase II testing by providing earlier determination of futility and prediction of phase III success, reducing overall phase II and III trial sizes, and shortening overall drug development time. This review examines issues in phase II testing and adaptive trial design. Key Words: adaptive design, biomarker studies, false discovery rate, multiplicity problem, phase II clinical trials Diseases of the circulatory (Cardiovascular) system In JACC: Basic to Translational Science Elsevier, 2017 4(2019), 3, Seite 428-437 (DE-627)865612463 (DE-600)2865010-4 2452302X nnns volume:4 year:2019 number:3 pages:428-437 https://doi.org/10.1016/j.jacbts.2019.02.005 kostenfrei https://doaj.org/article/23f6df0f77ac46e8b468a91a51e5ebb3 kostenfrei http://www.sciencedirect.com/science/article/pii/S2452302X19300658 kostenfrei https://doaj.org/toc/2452-302X Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 4 2019 3 428-437 |
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Summary: Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: <30% of drugs entering phase II studies fail to progress, and <58% of drugs go on to fail in phase III. Adaptive clinical trial design has been proposed as a way to reduce the costs of phase II testing by providing earlier determination of futility and prediction of phase III success, reducing overall phase II and III trial sizes, and shortening overall drug development time. This review examines issues in phase II testing and adaptive trial design. Key Words: adaptive design, biomarker studies, false discovery rate, multiplicity problem, phase II clinical trials |
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Summary: Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: <30% of drugs entering phase II studies fail to progress, and <58% of drugs go on to fail in phase III. Adaptive clinical trial design has been proposed as a way to reduce the costs of phase II testing by providing earlier determination of futility and prediction of phase III success, reducing overall phase II and III trial sizes, and shortening overall drug development time. This review examines issues in phase II testing and adaptive trial design. Key Words: adaptive design, biomarker studies, false discovery rate, multiplicity problem, phase II clinical trials |
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Summary: Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: <30% of drugs entering phase II studies fail to progress, and <58% of drugs go on to fail in phase III. Adaptive clinical trial design has been proposed as a way to reduce the costs of phase II testing by providing earlier determination of futility and prediction of phase III success, reducing overall phase II and III trial sizes, and shortening overall drug development time. This review examines issues in phase II testing and adaptive trial design. Key Words: adaptive design, biomarker studies, false discovery rate, multiplicity problem, phase II clinical trials |
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