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

Javed Butler*, Gregg C. Fonarow, Christopher O'Connor, Kirkwood Adams, Robert O. Bonow, Robert J. Cody, Sean P. Collins, Preston Dunnmon, Wilfried Dinh, Mona Fiuzat, Vasiliki V. Georgiopoulou, Stephen Grant, So Young Kim, Stuart Kupfer, Martin Lefkowitz, Robert J. Mentz, Frank Misselwitz, Bertram Pitt, Lothar Roessig, Erik SchelbertMonica Shah, Scott Solomon, Norman Stockbridge, Clyde Yancy, Mihai Gheorghiade

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

18 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)305-314
Number of pages10
JournalAmerican heart journal
Volume169
Issue number3
DOIs
StatePublished - Mar 1 2015

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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