相关参考文献
注意：仅列出部分参考文献，下载原文获取全部文献信息。Response-adaptive clinical trials: case studies in the medical literature
Andrew P. Grieve
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Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative
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Attitudes and opinions regarding confirmatory adaptive clinical trials: a mixed methods analysis from the Adaptive Designs Accelerating Promising Trials into Treatments (ADAPT-IT) project
William J. Meurer et al.
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Type I error rates of multi-arm multi-stage clinical trials: strong control and impact of intermediate outcomes
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Adaptive designs undertaken in clinical research: a review of registered clinical trials
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E. L. Gerety et al.
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CLINICAL TRIALS (2015)
Patient-centric trials for therapeutic development in precision oncology
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No solution yet for combining two independent studies in the presence of heterogeneity
Andrea Gonnermann et al.
STATISTICS IN MEDICINE (2015)
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Peter K. Kimani et al.
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Missing steps in a staircase: a qualitative study of the perspectives of key stakeholders on the use of adaptive designs in confirmatory trials
Munyaradzi Dimairo et al.
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The design of a multi-arm multi-stage (MAMS) phase III randomised controlled trial comparing alternative regimens for escalating (COMPARE) treatment of intermediate and high-risk oropharyngeal cancer with reflections on the complications of introducing a new experimental ARM
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Michael Cole et al.
TRIALS (2015)
Cross-sector surveys assessing perceptions of key stakeholders towards barriers, concerns and facilitators to the appropriate use of adaptive designs in confirmatory trials
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Nicola L. Harman et al.
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Steffen Ventz et al.
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The design of a multi-arm multi-stage (MAMS) phase III randomised controlled trial comparing alternative regimens for escalating (COMPARE) treatment of intermediate and high-risk oropharyngeal cancer with reflections on the complications of introducing a new experimental ARM
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BMC MEDICAL RESEARCH METHODOLOGY (2014)
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Robert L. Cuffe et al.
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Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency
Amelie Elsaesser et al.
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James M. S. Wason et al.
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Matilde Sanchez-Kam et al.
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Adaptive Design: Results of 2012 Survey on Perception and Use
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Novel Statistical Designs for Phase I/II and Phase II Clinical Trials With Dose-Finding Objectives
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Simultaneous confidence intervals that are compatible with closed testing in adaptive designs
D. Magirr et al.
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Uptake of novel statistical methods for early-phase clinical studies in the UK public sector
Thomas Jaki
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CONTEMPORARY CLINICAL TRIALS (2013)
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Richard Kaplan et al.
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Maximo Carreras et al.
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Yining Ye et al.
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Exact inference for adaptive group sequential designs
Ping Gao et al.
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Christina Yap et al.
Trials (2013)
Practical implementation of an adaptive phase I/II design in chronic myeloid leukaemia: evaluating both efficacy and toxicity using the EffTox design
Josephine Khan et al.
Trials (2013)
Impact of lack-of-benefit stopping rules on treatment effect estimates of two-arm multi-stage (TAMS) trials with time to event outcome
Babak Choodari-Oskooei et al.
TRIALS (2013)
Similarities and Differences of Bayesian Designs and Adaptive Designs for Medical Devices: A Regulatory View
Gregory Campbell
STATISTICS IN BIOPHARMACEUTICAL RESEARCH (2013)
Unblinded Adaptive Statistical Information Design Based on Clinical Endpoint or Biomarker
Sue-Jane Wang et al.
STATISTICS IN BIOPHARMACEUTICAL RESEARCH (2013)
Views on Emerging Issues Pertaining to Data Monitoring Committees for Adaptive Trials
Zoran Antonijevic et al.
THERAPEUTIC INNOVATION & REGULATORY SCIENCE (2013)
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D. Magirr et al.
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Tony W. Ho et al.
CEPHALALGIA (2012)
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AMERICAN STATISTICIAN (2011)
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Roger J. Lewis et al.
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Testing and estimation in flexible group sequential designs with adaptive treatment selection
M Posch et al.
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N Stallard et al.
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DL DeMets et al.
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Simple procedures for blinded sample size adjustment that do not affect the type I error rate
M Kieser et al.
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Adaptive randomized study of idarubicin and cytarabine versus troxacitabine and cytarabine versus troxacitabine and idarubicin in untreated patients 50 years or older with adverse karyotype acute myeloid leukemia
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Systematic reviews in health care -: Assessing the quality of controlled clinical trials
P Jüni et al.
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