Phase II Trials in Drug Development and Adaptive Trial Design
| Autor: | Gail A. Van Norman |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Drug lcsh:Diseases of the circulatory (Cardiovascular) system medicine.medical_specialty FDR false discovery rate SA-II single-arm phase II studies media_common.quotation_subject Phase (waves) Phases of clinical research 030204 cardiovascular system & hematology HF heart failure 03 medical and health sciences 0302 clinical medicine Critical point (thermodynamics) TRANSLATIONAL TOOLBOX medicine adaptive design Intensive care medicine multiplicity problem media_common AD adaptive (trial) design Adaptive clinical trial business.industry HF - Heart failure CV cardiovascular biomarker studies FDA Food and Drug Administration phase II clinical trials RP-II randomized phase II studies 030104 developmental biology Drug development lcsh:RC666-701 Adaptive design EMA European Medicines Agency false discovery rate Cardiology and Cardiovascular Medicine business |
| Zdroj: | JACC: Basic to Translational Science, Vol 4, Iss 3, Pp 428-437 (2019) JACC: Basic to Translational Science |
| ISSN: | 2452-302X |
| DOI: | 10.1016/j.jacbts.2019.02.005 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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