Abstract

Clinical evidence generation from and for representative populations can be improved through increased research access and ease of trial participation. To improve access and participation, a modern trial infrastructure is needed that broadens research into more routine practice. This commentary highlights current barriers, areas of advancement, and actions needed to enable continued transformation toward a modern trial infrastructure for an improved evidence generation system. The focus of this commentary is on the development of medical products (e.g., drugs, devices, biologics) and infrastructure issues within the United States, with the aim to have broader, multi-national applicability.

Details

Title
Overcoming the barriers to better evidence generation from clinical trials
Author
Kehoe, Lindsay 1   VIAFID ORCID Logo  ; Locke, Trevan 2 ; McClellan, Mark 2 ; Landray, Martin 3 ; Hernandez, Adrian 4 ; Okun, Sally 1 

1  Duke University, Clinical Trials Transformation Initiative, Durham, United States (GRID:grid.26009.3d) (ISNI:0000 0004 1936 7961) 
2  Duke-Margolis Institute for Health Policy, Durham, United States (GRID:grid.26009.3d) 
3  University of Oxford, Nuffield Department of Population Health, Oxford, United Kingdom (GRID:grid.4991.5) (ISNI:0000 0004 1936 8948); Protas, Manchester, United Kingdom (GRID:grid.4991.5) 
4  Duke University School of Medicine, Duke Clinical Research Institute, Durham, United States (GRID:grid.26009.3d) (ISNI:0000 0004 1936 7961) 
Pages
614
Publication year
2024
Publication date
Dec 2024
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-024-08460-8
ProQuest document ID
3105556310
Copyright
© The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.