biostudies-literatureMawocha SCNCATS NIH HHSNINDS NIH HHSNIH Common Fund and the FDA246-254https://www.ebi.ac.uk/biostudies/studies/S-EPMC5446276biostudies-literatureUnknown14(3)<h4>Background</h4>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.<h4>Methods</h4>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 questionnairClinical trials (London, England)A conceptual model for the development process of confirmatory adaptive clinical trials within an emergency research network.PMC5446276U01 NS059041U01 NS056975UL1 TR000371U01 NS073476U01NS073476Barsan WGMeurer WJLegocki LJFetters MDMawocha SCGuetterman TCLewis RJFrederiksen SBerry DAfalseA conceptual model for the development process of confirmatory adaptive clinical trials within an emergency research network.<h4>Background</h4>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.<h4>Methods</h4>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 questionnair2017-01-01T00:00:00Z2017 Jun2025-04-04T02:57:23.431Z2019-03-26T23:38:43ZS-EPMC54462762813582710.1177/1740774516688900