Our Work

Proactive Safety Surveillance: A Global Approach

Proactive Safety Surveillance: A Global Approach

Ensuring the safety of biological products, drugs, and devices in healthcare is the shared responsibility of regulatory, academic and industry-related stakeholders. Safety data are collected and analyzed not only throughout product development but also after approval, through analysis of observational data and/or designated studies. Post-market surveillance more closely represents the real-world setting, and some adverse events only manifest after regulatory approval and adoption as a result of wider dissemination to patients.

Current safety surveillance systems rely upon analysis of spontaneous, voluntary reports and of administrative claims, electronic medical records, and some post-marketing pharmacovigilance studies. A limited number of surveillance systems have utilized innovative analytical and statistical techniques, including data mining, machine learning and artificial intelligence to interrogate real-world data. While these approaches are important and complementary, they fail to harness the full power of cooperation across stakeholders and systems to realize global inclusivity in safety surveillance.

Convened by the MRCT Center in collaboration with others, the Proactive Safety Surveillance initiative (PSS) aims to improve upon current safety surveillance systems by creating a global, cooperative model for a more proactive, predictive safety surveillance system. A partnership with expert stakeholders will aid the selection, evaluation, and adaptation of new technologies, methodologies, and insights to support the medical determination and validity of safety signals. Such a system would also highlight the importance of a thorough benefit and risk analysis and provide better data for the global community. While inevitably challenging, we believe exploration of such a system holds the promise of increasing the timely detection, validation, and communication of important safety information.


  • Create a framework for an international approach to proactive drug and device safety surveillance, validation, and communication
  • Engage diverse and international representatives to examine the ethical, social, and political challenges of a global, proactive safety surveillance system
  • Develop a governance model for the initiative that is respectful of sovereign authorities and differing international laws and regulations
  • Develop one or more examples of pilot projects appropriate to test the advantages and limitations of a global proactive safety surveillance system

Key Milestones

  • December 2019: Core Team Conference
  • September 2019: Methodological Comparison Meeting
  • May 2019: Visioning Session
  • Jan – April 2019: Project Core Team established

Program Leadership & STAFF

  • Barbara E. Bierer, MD, Professor of Medicine, Harvard Medical School and Faculty Director, MRCT Center
  • Paul Bleicher, MD, PhD, Principal, Evident Health Strategies
  • Paul Chang, MD, Chief Safety Officer, Johnson & Johnson
  • William Crown, PhD, Distinguished Research Scientist, Brandeis University
  • David Madigan, PhD, Provost and Senior Vice President for Academic Affairs, Northeastern University
  • Sandra Morris, PhD, Vice President Strategy Realization, Johnson & Johnson
  • Frank Rockhold, PhD, Professor, Duke University
  • Joseph Ross, MD, Associate Professor of Medicine, Yale School of Medicine
  • Patrick Ryan, PhD, Vice President of Observational Health Data Analytics, Janssen Research and Development
  • Jodi Segal, MD, Professor, Johns Hopkins School of Medicine
  • Paul Stang, PhD, Vice-President Global Epidemiology, Johnson & Johnson
  • Joanne Waldstreicher, MD, Chief Medical Officer, Johnson & Johnson
  • Sarah White, MPH, Executive Director, MRCT Center

Project Resources