title: Reflections on the Adaptive Designs Accelerating Promising Trials Into Treatments (ADAPT-IT) Process-Findings from a Qualitative Study.
abstract: BACKGROUND
  The context for this study was the Adaptive Designs Advancing Promising Treatments Into Trials (ADAPT-IT) project, which aimed to incorporate flexible adaptive designs into pivotal clinical trials and to conduct an assessment of the trial development process. Little research provides guidance to academic institutions in planning adaptive trials.
  
  
  OBJECTIVE
  The purpose of this qualitative study was to explore the perspectives and experiences of stakeholders as they reflected back about the interactive ADAPT-IT adaptive design development process, and to understand their perspectives regarding lessons learned about the design of the trials and trial development.
  
  
  METHODS
  We conducted semi-structured interviews with ten key stakeholders and observations of the process. We employed qualitative thematic text data analysis to reduce the data into themes about the ADAPT-IT project and adaptive clinical trials.
  
  
  RESULTS
  The qualitative analysis revealed four themes: education of the project participants, how the process evolved with participant feedback, procedures that could enhance the development of other trials, and education of the broader research community.
  
  
  CONCLUSIONS
  While participants became more likely to consider flexible adaptive designs, additional education is needed to both understand the adaptive methodology and articulate it when planning trials.
authors.affiliation: Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Timothy C
authors.initials: TC
authors.lastname: Guetterman
authors.affiliation: Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Fetters
authors.affiliation: Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Laurie J
authors.initials: LJ
authors.lastname: Legocki
authors.affiliation: Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Samkeliso
authors.initials: S
authors.lastname: Mawocha
authors.affiliation: Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.
authors.forename: William G
authors.initials: WG
authors.lastname: Barsan
authors.affiliation: Department of Emergency Medicine, Harbor-UCLA Medical Center, Los Angeles, CA, USA; Los Angeles Biomedical Research Institute; David Geffen School of Medicine-University of California Los Angeles, Los Angeles, CA, USA; and Berry Consultants, Austin, TX, USA.
authors.forename: Roger J
authors.initials: RJ
authors.lastname: Lewis
authors.affiliation: Department of Biostatistics, University of Texas M.D. Anderson Cancer Center, Houston, TX; and Berry Consultants, Austin, TX, USA.
authors.forename: Donald A
authors.initials: DA
authors.lastname: Berry
authors.affiliation: Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.
authors.forename: William J
authors.initials: WJ
authors.lastname: Meurer
keywords: adaptive clinical trials; emergency medicine; neurological emergencies; qualitative research