Despite decades of progress in the diagnosis, treatment, and prevention of cardiovascular disease, its prevalence continues to grow in both developed and developing countries. We have constructed a model, the "cycle of quality," which connects the innovation of initial scientific discovery with validated methods of translating research into effective delivery. This model can serve as a basis for evaluating proposed efforts to improve interactions among private and public aspects of health care to accelerate development and appropriate adoption of new treatments, and to achieve greater penetration of effective behavioral therapies and established technologies, resulting in major improvements in cardiovascular health. [Health Affairs 26, no. 1 (2007): 62-74; 10.1377/hlthaff.26.1.62] A m e r i c an s o c i e t y h a s w i t n e s s e d a remarkable convergence of effective diagnostic, preventive, and therapeutic approaches to cardiovascular disease (CVD). At the same time, the overall prevalence of CVD and its sequelae are rising as a result of the aging of the population in developed countries, greater longevity in developing countries, and the global epidemics of diabetes and obesity. A global view is especially important, because the greatest increase in prevalence and mortality will occur in countries with developing economies, and much effective CVD prevention and treatment does not require expensive technology, although technological advances have the potential to improve the health of patients with CVD on a global scale. J a n u a r y / F e b r u a r y 2 0 0 7 Q u a l i t y

A public-private partnership to create a network of government and private databases to routinely evaluate and prioritize safety questions is in the public interest. Better methods are needed, and a knowledgeable workforce is required to conduct the surveillance and understand how to interpret the results. The international community will benefit from the availability of better methods and more experts.

The Clinical Trials Transformation Initiative (CTTI) identifies and promotes practices to increase the quality and efficiency of clinical trials through projects that generate empirical data on how trials are currently conducted, leading to recommendations for improvement.

The Clinical Trials Transformation Initiative reflects on 10 years of working to improve the quality and efficiency of clinical trials. This article highlights many of the Clinical Trials Transformation Initiative's accomplishments and offers examples of the impact that the Clinical Trials Transformation Initiative has had on the clinical trials enterprise. After conducting more than 25 projects and issuing recommendations for specific strategies to improve the design and execution of clinical trials, some common themes and lessons learned have emerged. Lessons include the importance of engaging many stakeholders, advanced planning to address critical issues, discontinuation of non-value added practices, and new opportunities presented by technology. Through its work, the Clinical Trials Transformation Initiative has also derived some operational best practices for conducting collaborative, multi-stakeholder projects covering project selection, project team dynamics and execution, and multi-stakeholder meetings and team discussions. Through these initiatives, the Clinical Trials Transformation Initiative has helped move the needle toward needed change in the clinical trials enterprise that has directly impacted stakeholders and patients alike.

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