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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5 Inspiring Collective Action: Perspectives from Federal Stakeholders and Reflections from Individual Workshop Participants
5 Inspiring Collective Action: Perspectives from Federal Stakeholders and Reflections from Individual Workshop Participants
Pages 65-78
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From page 65... ...
Panelists included Stacey Arnesen, chief of the Disaster Information Management Research Center in the Specialized Information Services of the National Library of Medicine (NLM) at NIH; Greg Burel; Redonna Chandler, deputy director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences (NCATS)
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From page 66... ...
Larsen also noted the need to determine costs associated with data collection, identify funding sources, and consider the sustainability of the enterprise. As an example of potential costs, he said that BARDA recently funded an expanded access protocol for the Ebola treatment ZMapp, including funding for data collection in two countries in West Africa and 11 sites in the United States.
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From page 67... ...
It is important to start now, and not wait until the day of an event to decide what questions to ask. National Center for Advancing Translational Sciences Part of the mission of NCATS is developing innovations that aid health research of all types, particularly tools that speed up the process of clinical research and data capture, Chandler said.1 NCATS is an excellent resource for the clinical networks aspect of MCM monitoring and assessment efforts, she said.
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From page 68... ...
For example, NCATS intramural researchers have significant expertise in subjects such as screening libraries of approved compounds for repurposing existing drugs. Office of the National Coordinator for Health Information Technology One area of focus for ONC is information transfer, particularly in emergencies, Fleming said.
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From page 69... ...
NLM has evolved from simply collecting information, to organizing and indexing the information, to discovering what can be done with data and considering issues around data sharing, open data, data analysis tools, and other areas. NLM has a lot to offer in the area of "data preparedness," Arnesen added, and in helping to develop tools for response operations that can be ready-to-go for data collection and data analysis.
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From page 70... ...
Therefore, it is important to gather requisite data to quickly assess whether the performance expectations extrapolated from preclinical studies are, in fact, correlated with how the MCM is performing in the real world. Decisions can then be made by state and local authorities regarding whether to continue use of the MCM or to stop deployment, she said.
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From page 71... ...
CTSA researchers understand both data collection and the delivery of clinical care, she said. Structurally, the CTSA Program provides funding to academic medical centers to serve as hubs within their localities; they are then networked to hospitals, federally qualified health centers, and other points-of-care delivery locations.
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From page 72... ...
In other words, show other stakeholders how this problem is also their problem, and how helping to solve it serves them as well, she said. PRIORITIZING ISSUES FOR ACTION: REFLECTIONS FROM INDIVIDUAL WORKSHOP PARTICIPANTS Following the final panel session, workshop speakers and attendees were invited to discuss potential strategies and actions in the areas of CONOPS, clinical networks, and sources of data (both electronic health data and big data)
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From page 73... ...
; collecting data and information to inform, refine approaches, and set priorities for PHE responses; standardizing information; potentially decreasing the risk of products if positive safety and efficacy data were collected; demonstrating return on investment; building systems for future scenarios; and saving lives. Lushniak described steps that could be undertaken within the coming year related to CONOPS for MCM monitoring and assessment, including • Explore the use of clinical trial networks for MCM monitoring and assessment and share lessons learned (potentially as part of a BARDA tabletop exercise)
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From page 74... ...
. Clinical Networks5 Cobb shared his observations on how an extensible clinical system for monitoring and assessing MCMs that is rapid, adaptable, scientifically robust, and minimally disruptive to the course of care during a PHE could be developed.
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From page 75... ...
Data Sources6 Bakken presented her perspective on how existing data sources, systems, and technical and human infrastructures can be leveraged to meet the needs of MCM monitoring and assessment for safety and effectiveness. She noted some key parameters, stakeholders, context, and potential solutions and action steps that could be considered.
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From page 76... ...
The volume of available data presents a challenge, but it is also an opportunity, said Bakken, though there are certain populations that are not presently included in datasets, including some international and tribal populations. Based on the workshop discussions, Bakken listed several potential opportunities, solutions, and next steps that could be leveraged, built upon, or undertaken within the next year: • Data preparedness framework and testing plan -- Consider which data sources, and what level of data veracity, are needed for which purposes.
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From page 77... ...
INSPIRING COLLECTIVE ACTION 77 CLOSING REMARKS Lushniak closed the workshop by thanking the various groups that made it a success: the planning committee, for volunteering their time for several months to plan and convene the workshop; the workshop speakers, who volunteered their knowledge and experience; the workshop sponsor, FDA, for bringing to light this important topic; the workshop participants for taking part in the discussions; National Academies staff; and workshop facilitator Laura Runnels. Many potential solutions were discussed throughout the workshop, said Lushniak, including a wide array of challenges and potential solutions and next steps.
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