Rescuing clinical trials in the united states and beyond:A call for action

Zubin J. Eapen, John P. Vavalle, Christopher B. Granger, Robert A. Harrington, Eric D. Peterson, Robert M. Califf

Research output: Contribution to journalArticlepeer-review

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. (Am Heart J 2013;165:837-47.).

Original languageEnglish (US)
Pages (from-to)837-847
Number of pages11
JournalAmerican heart journal
Volume165
Issue number6
DOIs
StatePublished - Jun 2013
Externally publishedYes

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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