Improving cardiovascular clinical trials conduct in the United States: recommendation from clinicians, researchers, sponsors, and regulators.

Journal Article (Journal Article)

Advances in medical therapies leading to improved patient outcomes are in large part related to successful conduct of clinical trials that offer critical information regarding the efficacy and safety of novel interventions. The conduct of clinical trials in the United States, however, continues to face increasing challenges with recruitment and retention. These trends are paralleled by an increasing shift toward more multinational trials where most participants are enrolled in countries outside the United States, bringing into question the generalizability of the results to the American population. This manuscript presents the perspectives and recommendations from clinicians, researchers, sponsors, and regulators who attended a meeting facilitated by the Food and Drug Administration to improve upon the current clinical trial trends in the United States.

Full Text

Duke Authors

Cited Authors

  • Butler, J; Fonarow, GC; O'Connor, C; Adams, K; Bonow, RO; Cody, RJ; Collins, SP; Dunnmon, P; Dinh, W; Fiuzat, M; Georgiopoulou, VV; Grant, S; Kim, S-Y; Kupfer, S; Lefkowitz, M; Mentz, RJ; Misselwitz, F; Pitt, B; Roessig, L; Schelbert, E; Shah, M; Solomon, S; Stockbridge, N; Yancy, C; Gheorghiade, M

Published Date

  • March 2015

Published In

Volume / Issue

  • 169 / 3

Start / End Page

  • 305 - 314

PubMed ID

  • 25728719

Electronic International Standard Serial Number (EISSN)

  • 1097-6744

Digital Object Identifier (DOI)

  • 10.1016/j.ahj.2014.12.001


  • eng

Conference Location

  • United States