Literature DB >> 26123873

The futility study--Progress over the last decade.

Bruce Levin1.   

Abstract

We review the futility clinical trial design (also known as the non-superiority design) with respect to its emergence and methodologic developments over the last decade, especially in regard to its application to clinical trials for neurological disorders. We discuss the design's strengths as a programmatic screening device to weed out unpromising new treatments, its limitations and pitfalls, and a recent critique of the logic of the method.
Copyright © 2015 Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Futility design; Non-superiority design; Phase II trials; Screening program

Mesh:

Year:  2015        PMID: 26123873      PMCID: PMC4639404          DOI: 10.1016/j.cct.2015.06.013

Source DB:  PubMed          Journal:  Contemp Clin Trials        ISSN: 1551-7144            Impact factor:   2.226


  41 in total

1.  Futility studies: spending a little to save a lot.

Authors:  Steven R Schwid; Gary R Cutter
Journal:  Neurology       Date:  2006-03-14       Impact factor: 9.910

Review 2.  Neuroprotective effects of creatine.

Authors:  M Flint Beal
Journal:  Amino Acids       Date:  2011-03-30       Impact factor: 3.520

3.  Predictive probability early termination plans for phase II clinical trials.

Authors:  J Herson
Journal:  Biometrics       Date:  1979-12       Impact factor: 2.571

4.  One-sample multiple testing procedure for phase II clinical trials.

Authors:  T R Fleming
Journal:  Biometrics       Date:  1982-03       Impact factor: 2.571

5.  Screening potential therapies: lessons learned from new paradigms used in Parkinson disease.

Authors:  Barbara C Tilley; Wendy R Galpern
Journal:  Stroke       Date:  2007-02       Impact factor: 7.914

6.  Tissue plasminogen activator for acute ischemic stroke.

Authors: 
Journal:  N Engl J Med       Date:  1995-12-14       Impact factor: 91.245

7.  Design innovations and baseline findings in a long-term Parkinson's trial: the National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson's Disease Long-Term Study-1.

Authors:  Jordan J Elm
Journal:  Mov Disord       Date:  2012-10       Impact factor: 10.338

Review 8.  Prognostic factors in ALS: A critical review.

Authors:  Adriano Chiò; Giancarlo Logroscino; Orla Hardiman; Robert Swingler; Douglas Mitchell; Ettore Beghi; Bryan G Traynor
Journal:  Amyotroph Lateral Scler       Date:  2009 Oct-Dec

9.  A pilot clinical trial of creatine and minocycline in early Parkinson disease: 18-month results.

Authors: 
Journal:  Clin Neuropharmacol       Date:  2008 May-Jun       Impact factor: 1.592

10.  Phase II trial of CoQ10 for ALS finds insufficient evidence to justify phase III.

Authors:  Petra Kaufmann; John L P Thompson; Gilberto Levy; Richard Buchsbaum; Jeremy Shefner; Lisa S Krivickas; Jonathan Katz; Yvonne Rollins; Richard J Barohn; Carlayne E Jackson; Ezgi Tiryaki; Catherine Lomen-Hoerth; Carmel Armon; Rup Tandan; Stacy A Rudnicki; Kourosh Rezania; Robert Sufit; Alan Pestronk; Steven P Novella; Terry Heiman-Patterson; Edward J Kasarskis; Erik P Pioro; Jacqueline Montes; Rachel Arbing; Darleen Vecchio; Alexandra Barsdorf; Hiroshi Mitsumoto; Bruce Levin
Journal:  Ann Neurol       Date:  2009-08       Impact factor: 10.422

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  5 in total

1.  Sequential tests of promise with discrete time-to-event data.

Authors:  Bruce Levin; Louise Kuhn; Cheng-Shiun Leu; Wei-Yann Tsai
Journal:  Contemp Clin Trials       Date:  2019-08-21       Impact factor: 2.226

2.  Transcranial Direct Current Stimulation vs Sham Stimulation to Treat Aphasia After Stroke: A Randomized Clinical Trial.

Authors:  Julius Fridriksson; Chris Rorden; Jordan Elm; Souvik Sen; Mark S George; Leonardo Bonilha
Journal:  JAMA Neurol       Date:  2018-12-01       Impact factor: 18.302

3.  Emtonjeni-A Structural Intervention to Integrate Sexual and Reproductive Health into Public Sector HIV Care in Cape Town, South Africa: Results of a Phase II Study.

Authors:  J E Mantell; D Cooper; T M Exner; J Moodley; S Hoffman; L Myer; C-S Leu; D Bai; E A Kelvin; K Jennings; Z A Stein; D Constant; V Zweigenthal; N Cishe; N Nywagi
Journal:  AIDS Behav       Date:  2017-03

4.  Statistical advances in clinical trials and clinical research.

Authors:  Guogen Shan; Sarah Banks; Justin B Miller; Aaron Ritter; Charles Bernick; Joseph Lombardo; Jeffrey L Cummings
Journal:  Alzheimers Dement (N Y)       Date:  2018-06-14

5.  Downstream or upstream administration of P2Y12 receptor blockers in non-ST elevated acute coronary syndromes: study protocol for a randomized controlled trial.

Authors:  Giuseppe Tarantini; Marco Mojoli; Ferdinando Varbella; Roberto Caporale; Stefano Rigattieri; Giuseppe Andò; Plinio Cirillo; Simona Pierini; Andrea Santarelli; Paolo Sganzerla; Nicoletta De Cesare; Ugo Limbruno; Alessandro Lupi; Roberto Ricci; Carlo Cernetti; Luca Favero; Francesco Saia; Loris Roncon; Valeria Gasparetto; Marco Ferlini; Federico Ronco; Luca Ferri; Daniela Trabattoni; Alessandra Russo; Vincenzo Guiducci; Carlo Penzo; Fabio Tarantino; Ciro Mauro; Alfredo Marchese; Battistina Castiglioni; Alessio La Manna; Matteo Martinato; Dario Gregori; Dominick J Angiolillo; Giuseppe Musumeci
Journal:  Trials       Date:  2020-11-24       Impact factor: 2.279

  5 in total

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