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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4 Considerations for Conducting Rapid Clinical Research on MCMs During a PHE
4 Considerations for Conducting Rapid Clinical Research on MCMs During a PHE
Pages 51-64
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From page 51... ...
For studies conducted rapidly during a PHE, it is more difficult to answer questions about how the product fits into the larger paradigm of care, what combination of therapies might be effective, how the product is best administered and dosed, or which subpopulations may benefit the most, said Peppercorn. Participants throughout the workshop considered these issues, including how operations for threat response could be adapted and how the current clinical trial infrastructure could be leveraged to facilitate rapid monitoring and assessment of MCM use in a PHE.
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From page 52... ...
This uncertainty makes it difficult to prospectively craft protocol designs and determine elements of clinical research that will be adaptable to a broad range of situations, said Proestel. Individual workshop panelists and participants discussed potential elements of predefined protocols and other considerations for clinical research on MCMs, such as comparator arms, prescreening for contraindications, and leveraging existing clinical networks.
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From page 53... ...
Comparator Arms When designing clinical protocols for products approved under the Animal Rule, it can be difficult to define a comparator for establishing efficacy, said Proestel. Even when there are well-collected, standardized data on the use of an MCM in an emergency, it is difficult to determine the effectiveness of an MCM without a comparator.
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From page 54... ...
Assessment of safety and effectiveness in a field study are among the post-approval commitments for this product, she said. If and when the antibody is deployed from SNS, whether for a confined local or mass exposure event, GSK is prepared to collect safety and efficacy data.
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From page 55... ...
. From a research operations standpoint, Proestel emphasized the importance of using existing clinical trial networks to achieve this connectivity.
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From page 56... ...
Communities will engage, but it is reasonable for them to expect to get something back from that investment of their time and resources. Barriers to Information Sharing Data Security Deven McGraw, deputy director, Health Information Privacy, Office for Civil Rights (OCR)
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From page 57... ...
Other HIPAA issues discussed by individual workshop participants included the impact of state laws, consumer-shared data, and emergency department data. State law HIPAA governs many of the entities that would contribute or use data for MCM monitoring and assessment; however, state law also plays a strong role, McGraw said.
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From page 58... ...
. Second, state laws must conform with the public health permission clause in HIPAA, which allows entities covered by the rule to use and share information for public health purposes.
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From page 59... ...
As previously noted in this section, an independent panel review following the Ebola crisis identified different government agencies as leads for future international PHEs, including tasking NIH with leading biomedical research during crises. Higgs also stressed the importance of working with local emergency operations systems, listening to the local experts, and establishing partnerships based on trust and agreement on the principles for the conduct of the research.
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From page 60... ...
Most health departments are stretched financially, and future funding for some critical public health preparedness grants will only remain stable or will be reduced. He added that many state and local health departments fund their public health preparedness programs entirely with these grants.
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From page 61... ...
Chris Kratochvil, a principal investigator for the National Ebola Training Education Center, said the center conducts training, education, and site visits for regional Ebola treatment centers across the United States, with funding from CDC and ASPR.4 Recent efforts have focused on setting up a research infrastructure within that network, including a central IRB, case report forms, and a data repository. They are also developing training protocols for the nurses at the Ebola treatment centers to be able to support clinical research.
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From page 62... ...
Moore agreed that administrative preparedness is a concern and is often not thought of until an event occurs and information is not being shared as needed. For example, the public health system in North Carolina is decentralized, she said, and local health directors have BOX 4-4 Exercising for Administrative Preparedness in PHEs Cobb described a preparedness exercise held in 2012 at the request of ASPR.
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From page 63... ...
, with the intent of understanding how communities might be made more resilient from a public health perspective. Barishansky remarked that many states lack the necessary statutory authority to conduct MCM monitoring and assessment.
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