State of the controlled clinical trial enterprise in the United States.

We undertook a survey of the current capability in the United States to conduct controlled clinical trials. The intention was to use the results as a foundation for understanding how to create a controlled clinical trial capability sufficient to meet future needs of US health care. For this purpose, using the results from an advanced search of ClinicalTrials.gov on 16 August 2009, we created a database consisting of actively recruiting interventional trials having at least one US investigator center. As of 16 August 2009, there were 10,974 actively recruiting interventional trials having at least one investigator center in the United States. These trials were seeking to recruit a total of 2.8 million subjects. Of the trials, 68% involved the study of drugs or biologicals. The data indicate that clinical research conducted in the United States is dominated by research on regulated products. We estimated that 1 of every 200 persons in the United States would need to participate as a subject in a clinical trial if the current clinical research portfolio is to be successfully completed.