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Scope Statement

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CTTI will conduct projects in support of its mission to identify practices that will increase the quality and efficiency of clinical trials. In this context “quality” is characterized by the ability to effectively answer the intended question about the benefits and risks of a medical product (therapeutic or diagnostic) or procedure, while assuring protection of human subjects.

CTTI will generate evidence about how to improve the design and execution of clinical trials. Projects about design will address principles generally applicable to clinical trials to assure that they are fit to accomplish their intended purpose.

While CTTI focuses on clinical trials, it may study other types of clinical research (e.g., registries) that can provide data to regulatory agencies. Although CTTI will concentrate initially on the design and conduct of clinical trials in the United States, it seeks to identify practice improvements that can be applied internationally.

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