Rescuing clinical trials in the United States and beyond: a call for action.

Published

Journal Article (Review)

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.

Full Text

Duke Authors

Cited Authors

  • Eapen, ZJ; Vavalle, JP; Granger, CB; Harrington, RA; Peterson, ED; Califf, RM

Published Date

  • June 2013

Published In

Volume / Issue

  • 165 / 6

Start / End Page

  • 837 - 847

PubMed ID

  • 23708153

Pubmed Central ID

  • 23708153

Electronic International Standard Serial Number (EISSN)

  • 1097-6744

International Standard Serial Number (ISSN)

  • 0002-8703

Digital Object Identifier (DOI)

  • 10.1016/j.ahj.2013.02.003

Language

  • eng