The U.S. Clinical Trials System—Is It Losing Ground?
By Gina Shaw – Clinical Oncology News
If you’re an adult with cancer in the United States, the odds that you will enroll in a clinical trial are slim: only about 4%. And if you’re the principal investigator for a proposed new clinical trial, you’ll have a mountain of paperwork to wade through and a long wait before your trial opens. On average, it takes 800 days from conception to activation and that’s if it’s a cooperative group study—a cancer center study requires an additional 200 days (Nat Clin Pract Oncol 2008;5:683, PMID: 19034294).
But outside the United States, the picture is different. Studies have found that European trials open and accrue at a significantly faster pace than U.S. trials. For example, a recent study in the Journal of Clinical Oncology compared patient enrollment and time to activate lung cancer trials between two major academic centers—Washington University School of Medicine in the United States and the University of Torino in Italy. On almost every measure, the pace was faster in Italy. The median time from submission of a trial to an institutional review board until open enrollment was 163 days at Washington University and 112.5 days at the University of Torino (P=0.048) (Figure 1). The median time for regulatory approval was 75 days at Washington University and 31 days at University of Torino. In addition, Italian researchers accrued more patients—a median of 37 patients per study, compared with just 7.4 patients in the United States. In a homogeneous subset of Phase II, industry-sponsored thoracic oncology trials, the differences were even more stark.
Go to Do we want to be the American computer industry, or do we want to be the American automotive industry?” to access alarming data about our sluggish clinical study protocol.
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