Patients and those who care for them want access to new drugs, devices, and biological products as quickly as possible, while also being assured that the benefits of these products outweigh the risks.  While well-designed randomized clinical trials are the most reliable way to get unbiased information to achieve this, our current system of conducting clinical trials is often paper-based, slow, and costly. Poor quality and inefficiency in clinical research can seriously limit the number of questions that we can answer about the appropriate uses of approved or licensed medical products and significantly delay access to new therapeutic innovations.

Increasingly clinical trials are being conducted outside of the United States (US).   The reasons behind this shift need to be understood so that US patients can continue to be represented in international clinical trials.  Reasonable numbers of US patients being included in trials is critically important to address the appropriate use of products by US citizens.

In light of these issues and concerns, the US Food and Drug Administration and Duke University joined together as founding members of a public–private partnership, the Clinical Trials Transformation Initiative (CTTI).  CTTI  brings together all interested stakeholders to identify practices that through broad adoption will increase the quality and efficiency of clinical trials.