Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency Going Beyond the Last Mile: Proceedings of a Workshop (2017) / Chapter Skim
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1 Introduction and Overview
1 Introduction and Overview
Pages 1-16
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; FDA approved using animal models because human efficacy testing is not ethical or feasible; or not yet FDA approved for any situation. Current medical product surveillance systems are typically passive systems that were not designed to provide information in the time frame necessitated by emergencies.
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Action Plan for Developing an Enhanced National Capability for Monitoring and Assessing Medical Countermeasures During Public Health Emergencies3 in 2013. The PHEMCE action plan helped to identify the current core capabilities for MCM monitoring and assessment: data collection and reporting (i.e., surveillance systems)
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The workshop was webcast live and the slide presentations and videos are archived on the meeting website.5 As previously noted, the workshop was organized into five panel sessions. However, to best reflect the workshop discussions and themes that arose over the 2 days, the rapporteurs for this proceedings chose to structure the discussions conceptually as follows: • The final section of this chapter provides workshop sponsor FDA's perspective on MCM monitoring and assessment during PHEs, which set the stage for workshop discussions.
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of the federal D government and of relevant stakeholders with an interest in building and maintaining a national PHE MCM active monitoring and assessment capability; • iscuss federal monitoring and assessment efforts (completed and ongo D ing) and opportunities for future work in areas, including o EHR capabilities, o role of big data, the o clinical trial networks, and o concept of operations for threat response; and • elp inform the development of MCM active monitoring and assessment H strategic plans for public health emergencies.
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Workshop speakers and panelists con templated how operations for threat response could be adapted and how the current clinical trial infrastructure could be leveraged to facilitate MCM monitoring and assessment in PHEs, with dis cussion of topics such as data and information sharing, protocol design, and governance. • Chapter 5 summarizes both the perspectives of federal stakeholders on key workshop takeaways, including barriers and opportunities for promoting monitoring and assessment of MCM use within their respective agencies, and reflections from individual workshop participants.
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The traditional medical product life cycle is a tightly controlled, iterative process, Maher said, and decisions are made by FDA at each developmental stage regarding whether a product advances (see Figure 1-1)
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In some cases, such as a mass casualty event, she added, such a product might have been made widely available. Maher highlighted several potential key challenges in developing MCMs, including the following: • T he affected population is only available for clinical research dur ing a PHE, so traditional clinical trials are not feasible.
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Although tools and capabilities are available with which to monitor and assess medical products, these tools were not originally developed with the purpose of rapidly collecting, analyzing, and gathering data in the midst of PHEs or using that information in real-time to inform decisions on the use of that product within present (and future)
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Maher challenged workshop participants to consider how and where such information about MCM performance could be captured and rapidly assessed without disrupting the ongoing emergency response. To move beyond the last mile and integrate monitoring and assessment into the MCM life cycle, FDA is reviewing its current capabilities and identifying opportunities in four main areas: electronic health data, unstructured/big data, operations for response, and clinical networks.
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Food and Drug Administration; EUA = Emergency Use Authorization; MCM = medical countermeasure; NIH = National Institutes of Health; PHE = public health emergency; PHEIC = Public Health Emergency of International Concern; SNS = Strategic National Stockpile; WHO = World Health Organization. SOURCE: Maher presentation, June 6, 2017.
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, or causing harm. Discussions at the workshop centered on performing research and collecting data to inform the benefit–risk profile of MCMs, which may be deployed during PHEs at varying developmental stages (i.e., an investigational product with limited preclinical data, a product approved under the Animal Rule, or an FDA-approved product that may have post-marketing commitments and requirements)
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Elizabeth Higgs, global health science advisor for the Division of Clinical Research at the National Institute of Allergy and Infectious Diseases (NIAID) at NIH, noted that clinical research on MCMs requires increased efficiency, expediency, and adaptability, relative to routine clinical development.
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For example, which patient populations are underrepresented during PHEs, how could this underrepresentation bias the data, and how could this issue be addressed in future data collection efforts? At a more granular level, participants noted that certain types of data are currently missing that would benefit MCM monitoring and assessment efforts, including medical histories and symptomatology.
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Existing Data Sources, Datasets, and Clinical Trial Infrastructure FDA noted at the outset of the workshop that its goal is not to create a new system to monitor and assess MCMs, but to build a PHEMCE monitoring and assessment component into existing infrastructure. However, most existing data sources are part of the traditional care delivery setting, and MCM dispensing often takes place in non-traditional settings.
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Challenges, limitations, and the potential for these opportunities were discussed. The use of existing clinical trial networks will be important to achieving rapid connectivity throughout the MCM monitoring and assessment enterprise, noted individual workshop participants.
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Effective Communication Among Stakeholders Individual participants called for better communication across stakeholders, including better processes for disseminating changes in policy and guidance from federal agencies down to local health departments, as well as ways to communicate information and questions back upstream. In consideration of collecting the best data possible, several participants observed that researchers could do better at articulating the value of data collection to health systems administrators, including explaining why they should share data from their systems and similarly articulating the value of public health preparedness effort to policy makers (see Policy and Regulation [Dis]
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