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US lacking participants in NHLBI-backed randomized CV trials
Kim E. J Am Coll Cardiol. 2011;58:671-676.
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The percentage of international participation in CV randomized controlled trials sponsored by the National Heart, Lung and Blood Institute was substantial when compared with US participation, results from a new study suggested.
Researchers used The NIH registry to search for phase III or IV CV randomized controlled trials (RCTs) funded by the NHLBI that had an outcome of MI, stroke or death and were published between 1997 and 2009. Of the 1,488 that were funded by the NHLBI, only 24 studies met the full criteria.
International participation (IP) was found in 19 trials that included 151,682 patients. The median IP was 9.5%. Across 11 coronary artery disease trials, nearly 50% of them had international enrollment. High IP was also found in high-risk trials and trials testing acute interventions.
Out of all CV RCTs, CAD trials had the most substantial rates of international enrollment. The researchers also noted that the most commonly listed international site was Canada (16 of 24 trials were conducted there), and that decreased participation of US patients in NHLBI-sponsored CV trials is a cause for concern.
In an accompanying editorial, Robert M. Califf, MD, of the Duke University School of Medicine, and Robert A. Harrington, MD, of the Duke Clinical Research Institute, both in Durham, N.C., reiterated the importance of both conducting more CV RCTs in the US and increasing participant enrollment at US-based sites.
“This report by Kim and colleagues represents a wake-up call. If we fail to heed it, we may see the US clinical research enterprise go the way of so many other American industries: lost to more efficient overseas competitors,” the authors wrote. “Such an outcome would be more than an economic disaster. It would also deprive the American public relevant, high-quality evidence essential for making appropriate decisions about health care.”
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