title: Rescuing clinical trials in the United States and beyond: a call for action.
abstract: Numerous challenges-financial, regulatory, and cultural-are hindering US participation and performance in multinational clinical trials. Consequently, it is increasingly unclear how the results of these trials should be applied to American patients, practice patterns, and systems of care. Both incremental and transformative changes are needed to revitalize US participation as well as the broader clinical trial enterprise. To promote consensus around the solutions needed to address the adverse trends in clinical research, the Duke Clinical Research Institute convenedstakeholders from academia, industry, and government. article summarizes the proceedings of this meeting and addresses: (1) adverse trends in the United States and multinational clinical trials, (2) the key issues that underlie these adverse trends, and (3) potential solutions to these problems.
authors.affiliation: Duke Clinical Research Institute, Durham, NC 27715, USA. zubin.eapen@duke.edu
authors.forename: Zubin J
authors.initials: ZJ
authors.lastname: Eapen
authors.forename: John P
authors.initials: JP
authors.lastname: Vavalle
authors.forename: Christopher B
authors.initials: CB
authors.lastname: Granger
authors.forename: Robert A
authors.initials: RA
authors.lastname: Harrington
authors.forename: Eric D
authors.initials: ED
authors.lastname: Peterson
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
mesh_terms: D035843:Biomedical Research / Q000458:organization & administration*; D026661:Clinical Trials Data Monitoring Committees / Q000458:organization & administration*; D006078:Government Programs; D006801:Humans; D058996:Quality Improvement / Q000639:trends*; D014481:United States