Clinical trials have become prohibitively expensive, slow to finish, and have not taken full advantage of evolving technology, resulting in major gaps in the availability of and knowledge about medical products. The Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded and hosted by Duke University and the U.S. Food and Drug Administration (FDA), develops and drives adoption of practices that will increase the quality and efficiency of clinical trials. For more than ten years, CTTI has informed and facilitated changes in clinical trial policies and practices. Duke will continue to support CTTI?s mission through the following specific aims: (1) Maintain an administrative and scientific infrastructure to implement all related activities under this collaborative effort. (2) Identify issues, develop plans, conduct research and activities, and produce recommendations and resources to improve clinical trials. (3) Encourage the adoption of recommendations through broad communication activities. (4) Identify and implement organizational activities to support system change. To accomplish these aims, CTTI will continue to work with its member organizations and a broader cross- section of clinical trial stakeholders to develop evidence-based recommendations and resources and support their adoption. CTTI?s recently refined areas of focus align with the FDA?s priorities and emphasize the importance of 1) clinical trial quality, 2) patients as equal partners, 3) investigator and site success, 4) appropriate use of mobile technologies, 5) novel clinical trial designs, and 6) trials that are safe and ethical. With a focus on these areas, CTTI will advance its vision for a high-quality clinical trial system that is patient- centered and efficient, enabling reliable and timely access to evidence-based therapeutic prevention and treatment options.
Clinical trials have become overly complex and expensive, resulting in major gaps in availability of and knowledge about medical products. The Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by the FDA and Duke University, and involving all stakeholders, develops and drives adoption of recommendations and resources to improve the quality and efficiency of clinical trials. Through the support of this cooperative agreement, Duke will host and support CTTI?s work to shape better clinical trials of the future.
