Paul Gallo

Summary

Affiliation: Novartis Institutes for BioMedical Research

Publications

  1. ncbi Adaptive designs in clinical drug development--an Executive Summary of the PhRMA Working Group
    Paul Gallo
    Novartis Pharmaceuticals, East Hanover, NJ 07936, USA
    J Biopharm Stat 16:275-83; discussion 285-91, 293-8, 311-2. 2006
  2. ncbi Operational challenges in adaptive design implementation
    Paul Gallo
    Novartis Pharmaceuticals, B and SR, One Health Plaza, East Hanover, NJ 07936, USA
    Pharm Stat 5:119-24. 2006
  3. ncbi Viewpoints on the FDA draft adaptive designs guidance from the PhRMA working group
    Paul Gallo
    Novartis, East Hanover, New Jersey, USA
    J Biopharm Stat 20:1115-24. 2010
  4. ncbi The future of drug development: advancing clinical trial design
    John Orloff
    Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, New Jersey 07936, USA
    Nat Rev Drug Discov 8:949-57. 2009
  5. ncbi Challenges in implementing adaptive designs: comments on the viewpoints expressed by regulatory statisticians
    Paul Gallo
    Novartis Pharmaceuticals, East Hanover, NJ, USA
    Biom J 48:591-7; discussion 613-22. 2006
  6. ncbi Adaptive designs in clinical drug development: opportunities, challenges, and scope reflections following PhRMA's November 2006 workshop
    Michael Krams
    Wyeth Research, Collegeville, Pennsylvania 19426, USA
    J Biopharm Stat 17:957-64. 2007

Detail Information

Publications6

  1. ncbi Adaptive designs in clinical drug development--an Executive Summary of the PhRMA Working Group
    Paul Gallo
    Novartis Pharmaceuticals, East Hanover, NJ 07936, USA
    J Biopharm Stat 16:275-83; discussion 285-91, 293-8, 311-2. 2006
    ..Three particular areas where it is felt that adaptive designs can be utilized beneficially are discussed: dose finding, seamless Phase II/III trials designs, and sample size reestimation...
  2. ncbi Operational challenges in adaptive design implementation
    Paul Gallo
    Novartis Pharmaceuticals, B and SR, One Health Plaza, East Hanover, NJ 07936, USA
    Pharm Stat 5:119-24. 2006
    ..We consider whether different types of adaptations might be more or less problematic with regard to this issue, and recommend steps that might be considered to mitigate this concern...
  3. ncbi Viewpoints on the FDA draft adaptive designs guidance from the PhRMA working group
    Paul Gallo
    Novartis, East Hanover, New Jersey, USA
    J Biopharm Stat 20:1115-24. 2010
    ....
  4. ncbi The future of drug development: advancing clinical trial design
    John Orloff
    Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, New Jersey 07936, USA
    Nat Rev Drug Discov 8:949-57. 2009
    ..Applications and examples of the use of these tools--such as Bayesian methodologies--in early- and late-stage drug development are discussed, as well as the advantages, challenges and barriers to their more widespread implementation...
  5. ncbi Challenges in implementing adaptive designs: comments on the viewpoints expressed by regulatory statisticians
    Paul Gallo
    Novartis Pharmaceuticals, East Hanover, NJ, USA
    Biom J 48:591-7; discussion 613-22. 2006
    ..O'Neill; 'A regulatory view on adaptive/flexible clinical trial design' by H. M. James Hung, Robert T. O'Neill, Sue-Jane Wang and John Lawrence; and 'Confirmatory clinical trials with an adaptive design' by Armin Koch...
  6. ncbi Adaptive designs in clinical drug development: opportunities, challenges, and scope reflections following PhRMA's November 2006 workshop
    Michael Krams
    Wyeth Research, Collegeville, Pennsylvania 19426, USA
    J Biopharm Stat 17:957-64. 2007
    ..Rather than providing a comprehensive review of the presentations given, we limit ourselves to a selection of key statements. The authors reflect the position of PhRMA's working group on adaptive designs...