Literature DB >> 16281432

ASTIN: a Bayesian adaptive dose-response trial in acute stroke.

Andrew P Grieve1, Michael Krams.   

Abstract

Understanding the dose-response is critical for successful drug development. We describe an adaptive design to efficiently learn about the dose-response and the ED95. A dynamic termination rule allows for early discontinuation either for efficacy or futility. The design was deployed in ASTIN, a phase II proof-of-concept trial of the neuroprotectant, neutrophil inhibitory factor (NIF), in acute stroke. We discuss the learning from this trial.

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Year:  2005        PMID： 16281432     DOI： 10.1191/1740774505cn094oa

Source DB:  PubMed          Journal:  Clin Trials        ISSN： 1740-7745            Impact factor:   2.486


  12 in total

1.  A change is in the wind as 'adaptive' clinical trials catch on.

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2.  Application of adaptive design methodology in development of a long-acting glucagon-like peptide-1 analog (dulaglutide): statistical design and simulations.

Authors:  Zachary Skrivanek; Scott Berry; Don Berry; Jenny Chien; Mary Jane Geiger; James H Anderson; Brenda Gaydos
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Review 3.  Clinical Trials of Immunomodulation in Ischemic Stroke.

Authors:  Roland Veltkamp; Dipender Gill
Journal:  Neurotherapeutics       Date:  2016-10       Impact factor: 7.620

Review 4.  Acute anti-inflammatory approaches to ischemic stroke.

Authors:  Gregory J del Zoppo
Journal:  Ann N Y Acad Sci       Date:  2010-10       Impact factor: 5.691

Review 5.  Randomized clinical trials in stroke research.

Authors:  Chul Ahn; Daniel Ahn
Journal:  J Investig Med       Date:  2010-02       Impact factor: 2.895

Review 6.  Decision-theoretic designs for small trials and pilot studies: A review.

Authors:  Siew Wan Hee; Thomas Hamborg; Simon Day; Jason Madan; Frank Miller; Martin Posch; Sarah Zohar; Nigel Stallard
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7.  Developing a Bayesian adaptive design for a phase I clinical trial: a case study for a novel HIV treatment.

Authors:  Alexina J Mason; Juan Gonzalez-Maffe; Killian Quinn; Nicki Doyle; Ken Legg; Peter Norsworthy; Roy Trevelion; Alan Winston; Deborah Ashby
Journal:  Stat Med       Date:  2016-11-27       Impact factor: 2.373

8.  Advancing clinical trial design in pulmonary hypertension.

Authors:  Andy P Grieve; Shien-Chung Chow; John Curram; Stephen Dawe; Lutz O Harnisch; Noreen R Henig; Hsien Ming J Hung; D Dunbar Ivy; Steven M Kawut; Mohammad H Rahbar; Shen Xiao; Martin R Wilkins
Journal:  Pulm Circ       Date:  2013-01       Impact factor: 3.017

9.  Design considerations and analysis planning of a phase 2a proof of concept study in rheumatoid arthritis in the presence of possible non-monotonicity.

Authors:  Feng Liu; Stephen J Walters; Steven A Julious
Journal:  BMC Med Res Methodol       Date:  2017-10-02       Impact factor: 4.615

Review 10.  Critical concepts in adaptive clinical trials.

Authors:  Jay Jh Park; Kristian Thorlund; Edward J Mills
Journal:  Clin Epidemiol       Date:  2018-03-23       Impact factor: 4.790
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