title: Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study.
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.
authors.affiliation: Lilly Diabetes, Eli Lilly and Company, Indianapolis, IN 46285, USA. spencer_ka@lilly.com
authors.forename: Kimberly
authors.initials: K
authors.lastname: Spencer
authors.forename: Kelly
authors.initials: K
authors.lastname: Colvin
authors.forename: Brad
authors.initials: B
authors.lastname: Braunecker
authors.forename: Marcia
authors.initials: M
authors.lastname: Brackman
authors.forename: Joyce
authors.initials: J
authors.lastname: Ripley
authors.forename: Paul
authors.initials: P
authors.lastname: Hines
authors.forename: Zachary
authors.initials: Z
authors.lastname: Skrivanek
authors.forename: Brenda
authors.initials: B
authors.lastname: Gaydos
authors.forename: Mary Jane
authors.initials: MJ
authors.lastname: Geiger
mesh_terms: D003920:Diabetes Mellitus / Q000188:drug therapy*; D004311:Double-Blind Method; D004763:Glucagon-Like Peptides / Q000031:analogs & derivatives; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007141:Immunoglobulin Fc Fragments / Q000627:therapeutic use*; D011993:Recombinant Fusion Proteins / Q000627:therapeutic use*; D012107:Research Design
chemical_list: D007004:Hypoglycemic Agents; D007141:Immunoglobulin Fc Fragments; D011993:Recombinant Fusion Proteins; D004763:Glucagon-Like Peptides; C555680:dulaglutide