Description of Collaborative Activity: |
The Critical Path Institute (C-Path), a pioneering non-profit organization dedicated to accelerating the pace and reducing the costs of medical product development by facilitating unique partnerships among a wide range of stakeholders, has formed a new consortium, the Global Pediatric Clinical Trials Network Pre-Launch Consortium (“Pre-Launch Consortium”).
According to Dr. Janet Woodcock, Director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), “Health care providers must have high-quality, reliable data to inform treatment decisions for their pediatric patients. C-Path has leveraged its expertise and stakeholders to support the development of a first-of-its-kind pediatric clinical trial network. The Pre-Launch Consortium signals an important step toward efficient and sustainable pediatric data collection and development of better treatments for children. I strongly support this effort and look forward to working with this global consortium.”
The mission of the Pre-Launch Consortium will be the formation of an independent non-profit entity that will operate a novel global pediatric clinical trials network (“Network”). The Pre-Launch Consortium will establish the Network, create its organizational and operating framework, and identify its leadership team. This work will involve collaborators from academia, government, scientific, and regulatory agencies, industry, foundations, child health advocacy groups, and other important stakeholders. |
Type of Collaborative Activity: |
Committee, Advisory Group, or Work Group
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