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Harold J. Burstein

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Harold J. Burstein

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Harold J. Burstein

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Harold J. Burstein

Trend-spotters looking back at 2010 have noted it as a year of lament over clinical trials in the United States, particularly in oncology. A widely cited Institute of Medicine report1 called for reinvigorating cooperative groups. Documenting need for reform, a study of the activation of phase III clinical trials in the NCI system revealed over 750 separate steps, 36 approval stages, and median 2.5 years to activation.2 Clearly, that process will not encourage investigators, clinical cancer centers, or pharmaceutical or other sponsors to engage more actively in clinical research. Moving into 2011, plans are afoot for a dramatic overhaul and consolidation of the cooperative groups. In addition, gains in accrual to European-based clinical trials have been well publicized. Reports suggest superior accrual in Europe to clinical trials in lymphoma and stem cell therapies. On a population basis, European oncologists have been accruing better to clinical trials than have American oncologists. Reports at the 2010 San Antonio Breast Cancer Symposium brought home the power of that improved accrual. The major results were dominated by out-of-U.S. clinical trials. A series of large, provocative, biologically-based neoadjuvant studies (neoALTTO, neoSPHERE, GeparQuinto) were presented on behalf of European investigators. The negative AZURE study originated in the United Kingdom, and the negative MA27 study, which included the U.S. Intergroup, originated in NCI-Canada. Texas hosted a triumph for out-of-U.S. oncology. Part of the problem is an overly burdened study approval process in the United States. A recent study compared lung cancer clinical trial activation and accrual at...