Literature DB >> 24781535

The risks of methodology aversion in drug regulation.

Peter Bauer1, Franz König1.   

Abstract

Decisions made by drug regulatory agencies require a high level of expertise in statistical methodologies. Without urgent efforts to enhance the level of such expertise in European regulatory agencies, there is a risk that they will not be able to meet emerging challenges such as quantitative modelling of benefit–risk profiles, wider use of innovative trial designs and greater public transparency of clinical trial data.

Mesh：

Year:  2014        PMID： 24781535     DOI： 10.1038/nrd4319

Source DB:  PubMed          Journal:  Nat Rev Drug Discov        ISSN： 1474-1776            Impact factor:   84.694


  4 in total

1.  Considerations on what constitutes a 'qualified statistician' in regulatory guidelines.

Authors:  Christoph Gerlinger; Lutz Edler; Tim Friede; Meinhard Kieser; Christos T Nakas; Martin Schumacher; Jørgen Seldrup; Norbert Victor
Journal:  Stat Med       Date:  2011-09-21       Impact factor: 2.373

2.  Statisticians in European regulatory agencies.

Authors:  Eva Skovlund
Journal:  Pharm Stat       Date:  2009 Oct-Dec       Impact factor: 1.894

Review 3.  The risks of risk aversion in drug regulation.

Authors:  Hans-Georg Eichler; Brigitte Bloechl-Daum; Daniel Brasseur; Alasdair Breckenridge; Hubert Leufkens; June Raine; Tomas Salmonson; Christian K Schneider; Guido Rasi
Journal:  Nat Rev Drug Discov       Date:  2013-11-15       Impact factor: 84.694

Review 4.  Role of modeling and simulation in pediatric investigation plans.

Authors:  Efthymios Manolis; Tariq Eldirdiry Osman; Ralf Herold; Franz Koenig; Paolo Tomasi; Spiros Vamvakas; Agnes Saint Raymond
Journal:  Paediatr Anaesth       Date:  2011-01-18       Impact factor: 2.556
  4 in total
  6 in total

1.  Twenty-five years of confirmatory adaptive designs: opportunities and pitfalls.

Authors:  Peter Bauer; Frank Bretz; Vladimir Dragalin; Franz König; Gernot Wassmer
Journal:  Stat Med       Date:  2015-03-16       Impact factor: 2.373

2.  Adaptive designs for subpopulation analysis optimizing utility functions.

Authors:  Alexandra C Graf; Martin Posch; Franz Koenig
Journal:  Biom J       Date:  2014-11-14       Impact factor: 2.207

3.  A proposal for a new PhD level curriculum on quantitative methods for drug development.

Authors:  T Jaki; A Gordon; P Forster; L Bijnens; B Bornkamp; W Brannath; R Fontana; M Gasparini; L V Hampson; T Jacobs; B Jones; X Paoletti; M Posch; A Titman; R Vonk; F Koenig
Journal:  Pharm Stat       Date:  2018-07-09       Impact factor: 1.894

Review 4.  Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation.

Authors:  Hans-Georg Eichler; Franz Koenig; Peter Arlett; Harald Enzmann; Anthony Humphreys; Frank Pétavy; Brigitte Schwarzer-Daum; Bruno Sepodes; Spiros Vamvakas; Guido Rasi
Journal:  Clin Pharmacol Ther       Date:  2019-10-01       Impact factor: 6.875

5.  Framework for the synthesis of non-randomised studies and randomised controlled trials: a guidance on conducting a systematic review and meta-analysis for healthcare decision making.

Authors:  Grammati Sarri; Elisabetta Patorno; Hongbo Yuan; Jianfei Jeff Guo; Dimitri Bennett; Xuerong Wen; Andrew R Zullo; Joan Largent; Mary Panaccio; Mugdha Gokhale; Daniela Claudia Moga; M Sanni Ali; Thomas P A Debray
Journal:  BMJ Evid Based Med       Date:  2020-12-09

6.  Identifying obstacles hindering the conduct of academic-sponsored trials for drug repurposing on rare-diseases: an analysis of six use cases.

Authors:  Marta Del Álamo; Christoph Bührer; Dirk Fisher; Matthias Griese; Paul Lingor; Giovanni Palladini; Nicolas Sireau; Virginie Hivert; Luca Sangiorgi; Florence Guillot; Juliane Halftermeyer; Lenka Soucková; Kristýna Nosková; Regina Demlová
Journal:  Trials       Date:  2022-09-15       Impact factor: 2.728
  6 in total

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