title: A conceptual model for the development process of confirmatory adaptive clinical trials within an emergency research network.
abstract: BACKGROUND
  Adaptive clinical trials use accumulating data from enrolled subjects to alter trial conduct in pre-specified ways based on quantitative decision rules. In this research, we sought to characterize the perspectives of key stakeholders during the development process of confirmatory-phase adaptive clinical trials within an emergency clinical trials network and to build a model to guide future development of adaptive clinical trials.
  
  
  METHODS
  We used an ethnographic, qualitative approach to evaluate key stakeholders' views about the adaptive clinical trial development process. Stakeholders participated in a series of multidisciplinary meetings during the development of five adaptive clinical trials and completed a Strengths-Weaknesses-Opportunities-Threats questionnaire. In the analysis, we elucidated overarching themes across the stakeholders' responses to develop a conceptual model.
  
  
  RESULTS
  Four major overarching themes emerged during the analysis of stakeholders' responses to questioning: the perceived statistical complexity of adaptive clinical trials and the roles of collaboration, communication, and time during the development process. Frequent and open communication and collaboration were viewed by stakeholders as critical during the development process, as were the careful management of time and logistical issues related to the complexity of planning adaptive clinical trials.
  
  
  CONCLUSIONS
  The Adaptive Design Development Model illustrates how statistical complexity, time, communication, and collaboration are moderating factors in the adaptive design development process. The intensity and iterative nature of this process underscores the need for funding mechanisms for the development of novel trial proposals in academic settings.
authors.affiliation: 1 Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Samkeliso C
authors.initials: SC
authors.lastname: Mawocha
authors.affiliation: 2 Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Fetters
authors.affiliation: 2 Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Laurie J
authors.initials: LJ
authors.lastname: Legocki
authors.affiliation: 2 Department of Family Medicine, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Timothy C
authors.initials: TC
authors.lastname: Guetterman
authors.affiliation: 1 Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.
authors.forename: Shirley
authors.initials: S
authors.lastname: Frederiksen
authors.affiliation: 1 Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.
authors.forename: William G
authors.initials: WG
authors.lastname: Barsan
authors.affiliation: 3 Department of Emergency Medicine, Los Angeles Biomedical Research Institute, David Geffen School of Medicine at UCLA, Harbor-UCLA Medical Center, Torrance, CA, USA.|4 Berry Consultants, Austin, TX, USA.
authors.forename: Roger J
authors.initials: RJ
authors.lastname: Lewis
authors.affiliation: 4 Berry Consultants, Austin, TX, USA.
authors.forename: Donald A
authors.initials: DA
authors.lastname: Berry
authors.affiliation: 1 Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA.|5 Department of Neurology, University of Michigan, Ann Arbor, MI, USA.
authors.forename: William J
authors.initials: WJ
authors.lastname: Meurer
mesh_terms: D000075522:Adaptive Clinical Trials as Topic / Q000379:methods*; D035843:Biomedical Research / Q000379:methods*; D003142:Communication; D003299:Cooperative Behavior; D006801:Humans; D015233:Models, Statistical; D036301:Qualitative Research; D012107:Research Design; D011795:Surveys and Questionnaires
keywords: Adaptive clinical trials; Strength–Weaknesses–Opportunities–Threats; confirmatory-phase clinical trials; mixed methods; neurology clinical trials; qualitative research