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Annals of Oncology 31 (suppl_4): S1142S1215

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Although the number of new compounds in development has increased over time, the high cost of clinical trials remains a challenge because of a number of factors, including ever-increasing time and financial pressures on clinician-investigators, excessively risk-averse interpretations of regional and federal regulations, the increased complexity of clinical trial protocols, and the high cost of on-site clinical data-quality monitoring (often including 100 percent source document verificationthe practice of comparing each data point entered in a clinical trial with information from the primary health records of a trial participant)