Partnership in Applied Comparative Effectiveness Science (PACES)

The PACES initiative sought to further the development of patient centered outcomes research (PCOR) in the FDA. The project was designed to help the agency build expertise in the analytic tools, methods and best practices, so that staff could be better equipped to work with sponsors, and other federal agencies, as they design and evaluate PCOR. Funded by the FDA, PACES was a partnership between the FDA, Johns Hopkins University, General Dynamics IT, the Lewin Group, and CMTP.

CMTP planned and supported a series of methods workshops focusing on such topics incuding:

  • Understanding the role of adaptive designs in Phase III research,
  • Examining optimal trial design to estimate treatment effects in subpopulations,
  • Advancing Bayesian methods to integrate historical information with newer trial design, and
  • Understanding the role of preference-based approaches to decision making when prescribing medications.

This was an important pilot project testing the utility and viability of enabling safe and secure academic researcher access to the agency’s vast stores of clinical trial data to enhance personalized medicine.  Ultimately, the FDA envisions these data could provide a springboard for advanced analytics, such as virtual clinical trials and the development of disease models that could further improve the product development process.