Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study

J Diabetes Sci Technol. 2012 Nov 1;6(6):1296-304. doi: 10.1177/193229681200600608.

Abstract

A wide variety of operational issues were encountered with the planning and implementation of an adaptive, dose-finding, seamless phase 2/3 trial for a diabetes therapeutic. Compared with a conventional design, significant upfront planning was required, as well as earlier, more integrated cross-functional coordination. The existing infrastructure necessitated greater flexibility to meet the needs of the adaptive design. Rapid data acquisition, analysis, and reporting were essential to support the successful implementation of the adaptive algorithm. Drug supply for nine treatment arms had to be carefully managed across many sites worldwide. Details regarding these key operational challenges and others will be discussed along with resolutions taken to enable successful implementation of this adaptive, seamless trial.

Trial registration: ClinicalTrials.gov NCT00734474.

Publication types

  • Clinical Trial, Phase II
  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Diabetes Mellitus / drug therapy*
  • Double-Blind Method
  • Glucagon-Like Peptides / analogs & derivatives
  • Humans
  • Hypoglycemic Agents / therapeutic use*
  • Immunoglobulin Fc Fragments / therapeutic use*
  • Recombinant Fusion Proteins / therapeutic use*
  • Research Design*

Substances

  • Hypoglycemic Agents
  • Immunoglobulin Fc Fragments
  • Recombinant Fusion Proteins
  • Glucagon-Like Peptides
  • dulaglutide

Associated data

  • ClinicalTrials.gov/NCT00734474