A second issue concerned streamlining, which addressed whether the existing system is effective and efficient, and produces the highest-quality data for the lowest possible investment. If the answer was negative, the Roundtable members asked the speakers to identify how the system could be improved. Finally, Roundtable members asked the speakers what could be done to improve the quality of data generated from trials performed in some foreign countries.

The workshop was successful in broadening the dialog among FDA, industry, and the public on the subject of data quality and validity in clinical trials for the regulatory decision-making process. Although the participants presented and discussed many important issues such as the identification of opportunities for significant improvement in the overall process, the nature of any workshop is that it cannot serve as an exhaustive exploration of the subject matter being addressed. Therefore, the proceedings in this report contain only the information that emerged from the workshop itself.

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