California Technology Assessment Forum (CTAF) to design an additional study of a promising technology.

"There has been an increasing consensus on the need to expand the capacity to identify critical questions about new technologies from the perspective of the health care decision makers and the need to develop strategies to conduct these studies quickly and affordably," said Sean Tunis, MD, MSc, the founder and director of the CMTP. "Our hope is that by developing a collaborative approach to the design and execution of these studies, decision makers will have the information necessary to more rapidly adopt high value technologies and more rapidly abandon those of little or no value."

Specific examples of technologies that may be studied by the CMTP include tele-ICU, intensity modulated radiation therapy, and minimally invasive bariatric surgery. Bariatric surgery has experienced an eight-fold increase between 1998 and 2003, while undergoing limited evaluation of safety and long-term health outcomes. Each study will be developed through workgroups that include patients, clinicians, payers, product developers, methodologists, and other experts as necessary.

The CMTP is the first private organization to directly address the critical knowledge gaps commonly identified in systematic reviews by such organizations as the Agency for Healthcare Research and Quality, clinical practice guidelines from medical professional organizations, and technology assessments conducted by many large health plans.

These groups and others point out that clinical research in the U.S. typically involves only two "pillars" – the medical product industry focused on product development and obtaining FDA approval and the National Institutes of Health (NIH) with a primary focus on discovery and the initial demonstration of clinical efficacy. By developing a model for a "third research pillar" – focused on the real-world questions asked by health care decision makers, the CMTP intends to address:

1. • Comparative effectiveness of new technologies against current standards of care
2. • Studies of procedures or technologies not regulated by the FDA (such as surgical procedures and some pharmacogenomic tests)
3. • Outcomes not typically measured in regulatory trials, such as quality of life and health care utilization
4. • Drug/device complication rates/side effects in real world settings
5. • Risks/benefits of common off-label uses
6. • Risks/benefits to important patient subgroups or those excluded from trials

During the CMTP’s first year of operation it will establish a broad-based steering group of health care decision makers; develop partnerships with related initiatives such as the Institute of Medicine’s Roundtable on Evidence-Based Medicine, the new Institute for Clinical and Economic Review (ICER) at Harvard Medical School, the New England Healthcare Institute, and the Integrated Healthcare Association; and select and design pilot studies for three promising emerging technologies. For more information about the CMTP, visit www.cmtpnet.org .

About HealthTech

HealthTech is a nonprofit research and education organization that develops objective forecasts, innovative decision-making tools, and facilitates a learning network of experts for the benefit of healthcare systems, hospitals, safety-net providers, government agencies, and others facing critical decisions on emerging healthcare technologies. For more information, visit www.healthtech.org .

About California Healthcare Foundation

Based in Oakland, the California HealthCare Foundation (CHCF) is an independent philanthropy committed to improving California's health care delivery and financing systems. For more information, visit www.chcf.org.

About Blue Shield of California Foundation

The Blue Shield of California Foundation is one of the largest health care grant-making organizations in California, awarding $30 million last year. The foundation was formed by Blue Shield of California, a not-for-profit corporation with more than 3.2 million members, 4,300 employees and 20 offices throughout California. For more information, visit www.blueshieldcafoundation.org .

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