GLOBALIZATION OF CLINICAL TRIALS

To encourage the Food and Drug Administration (FDA) to use its existing authority to increase monitoring and inspection of foreign clinical trials to ensure the integrity and quality of those studies; further,

To advocate that the FDA expand its oversight of clinical trials conducted abroad by continuing to pursue innovative strategies, such as increased collaboration with foreign regulatory agencies and changes in domestic regulatory processes that support timely submission of foreign clinical trial information; further, 

To encourage the FDA to establish a standardized electronic format and reporting standards that would be required for submission of data from foreign clinical trials; further, 

To support the ethical treatment of patients in foreign clinical trials in accordance with international standards designed to protect human subjects; further,

To encourage public and private research to study the impact of the globalization of clinical trials on patient care.