See All Projects

Proactive Safety Surveillance

Focus Area: Current Project

Focus Area: Ethics, Conduct, and Oversight

Proactive Safety Surveillance

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 aims to improve upon the current safety surveillance systems by creating a global, cooperative model for a more proactive, predictive safety surveillance approach. A partnership of best minds 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 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

  • Creation of an approach to a proactive safety surveillance system that is global in design and scale and that has the potential to identify and validate safety concerns efficiently and cooperatively.
  • 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:

  • Summer – Winter 2019: Work groups activities
  • Winter 2019/2020: Proactive Safety Surveillance Conference
  • Spring 2020 – forward: Design Phase

Key Milestones:

  • Jan – April 2019: Project Core Team established
  • May 2019: Visioning Session

Program leadership:

  • Barbara E. Bierer, MD, Professor of Medicine, Harvard Medical School and Faculty Director, MRCT Center
  • William Crown, PhD,Chief Scientific Officer, OptumLabs
  • Frank Rockhold, PhD, Professor, Duke University
  • Joseph Ross, MD, Associate Professor of Medicine, Yale School of Medicine
  • Joanne Waldstreicher, MD, Chief Medical Officer, Johnson & Johnson

Program Manager: Laura Meloney