title: Optimizing adaptive design for Phase 2 dose-finding trials incorporating long-term success and financial considerations: A case study for neuropathic pain.
abstract: In this paper, we propose an adaptive randomization design for Phase 2 dose-finding trials to optimize Net Present Value (NPV) for an experimental drug. We replace the traditional fixed sample size design (Patel, et al., 2012) by this new design to see if NPV from the original paper can be improved. Comparison of the proposed design to the previous design is made via simulations using a hypothetical example based on a Diabetic Neuropathic Pain Study.
authors.affiliation: Abbvie Inc., North Chicago, IL, USA. Electronic address: jingjing.gao@abbvie.com.
authors.forename: Jingjing
authors.initials: J
authors.lastname: Gao
authors.affiliation: Alkermes, Waltham, MA, USA.
authors.forename: Narinder
authors.initials: N
authors.lastname: Nangia
authors.affiliation: Abbvie Inc., North Chicago, IL, USA.
authors.forename: Jia
authors.initials: J
authors.lastname: Jia
authors.affiliation: Cytel Inc., Cambridge, MA, USA.
authors.forename: James
authors.initials: J
authors.lastname: Bolognese
authors.affiliation: Cytel Inc., Cambridge, MA, USA.
authors.forename: Jaydeep
authors.initials: J
authors.lastname: Bhattacharyya
authors.affiliation: Cytel Inc., Cambridge, MA, USA.
authors.forename: Nitin
authors.initials: N
authors.lastname: Patel
mesh_terms: D000700:Analgesics / Q000008:administration & dosage* / Q000191:economics / Q000627:therapeutic use; D017322:Clinical Trials, Phase II as Topic / Q000379:methods*; D003362:Cost-Benefit Analysis; D003929:Diabetic Neuropathies / Q000188:drug therapy* / Q000191:economics; D004305:Dose-Response Relationship, Drug; D023381:Endpoint Determination / Q000379:methods; D006801:Humans; D008962:Models, Theoretical; D010147:Pain Measurement; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D000700:Analgesics