Format

Send to

Choose Destination
Contemp Clin Trials. 2017 Jun;57:69-86. doi: 10.1016/j.cct.2017.03.011. Epub 2017 Apr 4.

Optimizing adaptive design for Phase 2 dose-finding trials incorporating long-term success and financial considerations: A case study for neuropathic pain.

Author information

1
Abbvie Inc., North Chicago, IL, USA. Electronic address: jingjing.gao@abbvie.com.
2
Alkermes, Waltham, MA, USA.
3
Abbvie Inc., North Chicago, IL, USA.
4
Cytel Inc., Cambridge, MA, USA.

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.

PMID:
28385653
DOI:
10.1016/j.cct.2017.03.011
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center