The Partnership in Applied Comparative Effectiveness Science (PACES) initiative aims to advance comparative effectiveness research (CER) by leveraging the Food and Drug Administration’s (FDA) immense and previously unused stores of data. The FDA has established a database to improve the agency’s management of data and create structured, scientific data repositories. Utilizing the database, the agency aims to build CER data standards, infrastructure, tools, skills, and capacity. The PACES initiative will facilitate the development of CER studies, which will allow the FDA to better understand which interventions are most effective for patients under specific circumstances-a key part of the FDA’s public health mission. A standardization of FDA data coupled with a better understanding of clinical interventions has the potential to ultimately transform the regulatory review and decision-making process.
The FDA has partnered with Johns Hopkins University (JHU), CMTP, Buccaneer Computer Systems and Services, Inc and the Lewin Group on the PACES initiative. CMTP is facilitating the priority-setting process, leading the stakeholder identification process, and providing the methodology for collecting stakeholder input about research needs. In February 2011, CMTP coordinated an internal PACES workshop, which brought together investigators and scientists from JHU and the FDA. The workshop facilitated information exchange regarding CER methodologies and FDA data between the project teams and developed a shared understanding of the underlying principles of CER, the immediate objectives of the PACES initiative, and the broader vision for CER at the FDA.
CMTP is currently developing a one-day multi-disciplinary workshop composed of both internal and external stakeholders for the PACES project. Expert stakeholders will provide additional perspectives and feedback on the issues raised and research plans discussed in the internal PACES workshop.
For more information, contact Steve Phurrough.