{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Mawocha SC"],"funding":["NCATS NIH HHS","NINDS NIH HHS","NIH Common Fund and the FDA"],"pagination":["246-254"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC5446276"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["14(3)"],"pubmed_abstract":["<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 questionnair"],"journal":["Clinical trials (London, England)"],"pubmed_title":["A conceptual model for the development process of confirmatory adaptive clinical trials within an emergency research network."],"pmcid":["PMC5446276"],"funding_grant_id":["U01 NS059041","U01 NS056975","UL1 TR000371","U01 NS073476","U01NS073476"],"pubmed_authors":["Barsan WG","Meurer WJ","Legocki LJ","Fetters MD","Mawocha SC","Guetterman TC","Lewis RJ","Frederiksen S","Berry DA"],"additional_accession":[]},"is_claimable":false,"name":"A conceptual model for the development process of confirmatory adaptive clinical trials within an emergency research network.","description":"<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 questionnair","dates":{"release":"2017-01-01T00:00:00Z","publication":"2017 Jun","modification":"2025-04-04T02:57:23.431Z","creation":"2019-03-26T23:38:43Z"},"accession":"S-EPMC5446276","cross_references":{"pubmed":["28135827"],"doi":["10.1177/1740774516688900"]}}