Clinical trials and the consequent benefits to society are in jeopardy in the United States because of a decline in the ability to recruit patients in a timely manner to trials addressing key clinical issues. Current initiatives (eg, the Clinical Trials Transformation Initiative and the proposed National Center for Advancing Translational Sciences) and the recent Institute of Medicine report1 each recognize that successful recruitment and retention of participants in clinical trials is critical for improving the efficiency and effectiveness of phase 3 and 4 clinical trials and that action to ensure adequate enrollment is urgently needed. Too often trial enrollment fails or is significantly delayed, leading to substantial additional costs to the sponsor. Of particular concern is the failure of US trials to meet desired participant enrollment and the trend toward increasing emphasis on recruitment abroad.
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