Affiliation: Novartis Institutes for BioMedical Research
- Adaptive designs in clinical drug development--an Executive Summary of the PhRMA Working GroupPaul 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...
- Operational challenges in adaptive design implementationPaul 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...
- Viewpoints on the FDA draft adaptive designs guidance from the PhRMA working groupPaul Gallo
Novartis, East Hanover, New Jersey, USA
J Biopharm Stat 20:1115-24. 2010....
- The future of drug development: advancing clinical trial designJohn 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...
- Challenges in implementing adaptive designs: comments on the viewpoints expressed by regulatory statisticiansPaul 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...
- Adaptive designs in clinical drug development: opportunities, challenges, and scope reflections following PhRMA's November 2006 workshopMichael 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...