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Proactive Safety Surveillance: A Global Approach

Focus Area: Current Project

Focus Area: Ethics, Conduct, and Oversight

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, by analysis of observational data. Post-market surveillance more closely represents the real-world setting, and some adverse events only manifest after regulatory approval and adoption as a consequence 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 of global inclusivity.

Convened by the MRCT Center in collaboration with others, the Proactive Safety Surveillance initiative (PSS) aims to improve upon the current safety surveillance systems by creating a global, cooperative modelfor a more proactive, predictive safety surveillance system. A partnership of stakeholders  with diverse perspectives will enable the evaluation and adaptation of new technologies, methodologies, and insights to better support the determination of the medical importance and validity of safety signals, 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.

Current Status: Active

Anticipated Impact

  • Enhanced identification and validation of safety signals through global cooperation, transparency, and improved communication
  • Stakeholders, including academia, industry, regulatory agencies and the general public will benefit from the cooperative partnership, transparency, and commitment to safety.

Objectives:

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

Upcoming:

  • Spring – Fall 2021: Socialization and Support Phase

Key Milestones:

  • Jan – April 2019: Project Core Team established
  • May 2019: Visioning Session
  • September 2019: Methodological Comparison Meeting
  • December 2019: Core Team Conference
  • Winter-Spring 2020: Drafting Phase
  • Summer-Fall 2020: Experimental Design Phase

Program leadership:

  • 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

Program Manager:

  • Laura Meloney, MSc, MPH