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

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 f...

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Bibliographic Details
Published in:The American heart journal 2015-03, Vol.169 (3), p.305-314
Main Authors: Butler, Javed, MD, MPH, Fonarow, Gregg C., MD, O’Connor, Christopher, MD, Adams, Kirkwood, MD, Bonow, Robert O., MD, MS, Cody, Robert J., MD, MBA, Collins, Sean P., MD, MSc, Dunnmon, Preston, MD, MBA, Dinh, Wilfried, MD, Fiuzat, Mona, PharmD, Georgiopoulou, Vasiliki V., MD, MPH, Grant, Stephen, MD, Kim, So-Young, MD, Kupfer, Stuart, MD, Lefkowitz, Martin, MD, Mentz, Robert J., MD, Misselwitz, Frank, MD, PhD, Pitt, Bertram, MD, Roessig, Lothar, MD, Schelbert, Erik, MD, MS, Shah, Monica, MD, Solomon, Scott, MD, Stockbridge, Norman, MD, Yancy, Clyde, MD, MS, Gheorghiade, Mihai, MD
Format: Article
Language:English
Subjects:
Biomedical research
Cardiovascular
Clinical trials
Clinical Trials as Topic - economics
Clinical Trials as Topic - standards
Costs
Disease
Drug therapy
Heart Failure
Humans
Infrastructure
Laboratories
Meetings
Personnel Selection
Pharmaceutical industry
Practice Guidelines as Topic
Trends
United States
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Summary: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.
ISSN:0002-8703
1097-6744
DOI:10.1016/j.ahj.2014.12.001