Please use this identifier to cite or link to this item: https://doi.org/10.1186/1750-1172-3-11
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dc.titleAdaptive design methods in clinical trials - A review
dc.contributor.authorChow, S.-C
dc.contributor.authorChang, M
dc.date.accessioned2020-10-20T08:28:02Z
dc.date.available2020-10-20T08:28:02Z
dc.date.issued2008
dc.identifier.citationChow, S.-C, Chang, M (2008). Adaptive design methods in clinical trials - A review. Orphanet Journal of Rare Diseases 3 (1) : 11. ScholarBank@NUS Repository. https://doi.org/10.1186/1750-1172-3-11
dc.identifier.issn1750-1172
dc.identifier.urihttps://scholarbank.nus.edu.sg/handle/10635/178235
dc.description.abstractIn recent years, the use of adaptive design methods in clinical research and development based on accrued data has become very popular due to its flexibility and efficiency. Based on adaptations applied, adaptive designs can be classified into three categories: prospective, concurrent (ad hoc), and retrospective adaptive designs. An adaptive design allows modifications made to trial and/or statistical procedures of ongoing clinical trials. However, it is a concern that the actual patient population after the adaptations could deviate from the originally target patient population and consequently the overall type I error (to erroneously claim efficacy for an infective drug) rate may not be controlled. In addition, major adaptations of trial and/or statistical procedures of on-going trials may result in a totally different trial that is unable to address the scientific/medical questions the trial intends to answer. In this article, several commonly considered adaptive designs in clinical trials are reviewed. Impacts of ad hoc adaptations (protocol amendments), challenges in by design (prospective) adaptations, and obstacles of retrospective adaptations are described. Strategies for the use of adaptive design in clinical development of rare diseases are discussed. Some examples concerning the development of Velcade intended for multiple myeloma and non-Hodgkin's lymphoma are given. Practical issues that are commonly encountered when implementing adaptive design methods in clinical trials are also discussed. © 2008 Chow and Chang; licensee BioMed Central Ltd.
dc.publisherBMC
dc.rightsAttribution 4.0 International
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourceUnpaywall 20201031
dc.subjectclinical trial
dc.subjecthuman
dc.subjectmethodology
dc.subjectphase 2 clinical trial
dc.subjectphase 3 clinical trial
dc.subjectrandomization
dc.subjectrare disease
dc.subjectreview
dc.subjectstatistics
dc.subjectClinical Trials as Topic
dc.subjectClinical Trials, Phase II as Topic
dc.subjectClinical Trials, Phase III as Topic
dc.subjectHumans
dc.subjectRandom Allocation
dc.subjectRare Diseases
dc.subjectResearch Design
dc.subjectStatistics as Topic
dc.typeReview
dc.contributor.departmentDUKE-NUS MEDICAL SCHOOL
dc.description.doi10.1186/1750-1172-3-11
dc.description.sourcetitleOrphanet Journal of Rare Diseases
dc.description.volume3
dc.description.issue1
dc.description.page11
dc.published.statepublished
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