Use of a pathogen X tabletop exercise to assess the operational response preparedness of an emerging infectious diseases research network

Abstract

In mid-2020, the Centers for Research in Emerging Infectious Diseases (CREID) Network was established to address critical gaps in research expertise and capacity in emerging and re-emerging infectious diseases (EIDs). As the Network was established during the COVID-19 pandemic, most of the Network’s research centers initially focused on SARS-CoV-2 research. By the end of 2021, the Network leadership realized that it had a blind spot with regards to research centers and their sites’ overall capacities and stakeholder connections. To foster more meaningful and deeper levels of coordination and collaboration across research centers, as well as stress-test its capacity and readiness for rapid research during an EID outbreak. CREID conducted a tabletop exercise (TTX) during its Annual Partners Meeting in August 2022. Through the 2-day TTX, participants provided insight into their institutions’ resources, stakeholder relationships, and research engagement before and after an EID outbreak; additionally, technical and operational challenges and solutions with regards to a successful outbreak research response were discussed. TTX participants’ feedback was used to improve the Network’s operational research response framework and processes. Given the limited existing resources on TTX for infectious disease outbreaks, the materials developed for the TTX and reported here can serve as a reference for determining and preparing for any research institution’s role in pandemic preparedness and response research efforts.

Introduction

Since 1980, there has been a steady increase in the number of global infectious disease outbreaks—including those due to emerging and re-emerging infectious diseases (EIDs)—at an estimated rate of increase of 6.7% annually (1). These outbreaks represent a threat to human health and global security, and are associated with changes in climate and the human-animal interface in high-risk areas, community interconnectivity, and travel and migration patterns (2–4). Global EID hotspots include forested tropical regions where interactions between humans and animals, specifically wildlife, are frequent and land-use changes are occurring (5). Recent examples of country, regional, and global EID outbreaks include Ebola in 2014–2016 (West Africa) (6) and 2018–2020 (Democratic Republic of the Congo) (7), Zika in 2015–2016 in Latin America (8), Middle East respiratory syndrome (MERS) in 2015 (South Korea) (9), Mpox in 2022 and 2024 (10), and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 2020–2023 (11). Because EID outbreaks occur at unpredictable intervals and in geographically diverse locations, the current research infrastructure has limited capacity to rapidly respond to them. The recent global experiences combating Ebola, Zika, MERS, Mpox, and SARS-CoV-2 highlights the urgent need for close coordination and international research-focused partnerships during EID outbreaks.

Critical contemporaneous research necessary to inform clinical care and the public health response during EID outbreaks has been historically slow due to physical, logistic, and operational in-country barriers and challenges. Lack of coordinated and relevant capacity, expertise and infrastructure can result in significant delays in conducting critical outbreak-related research. For example, Brazil announced Zika as a public health emergency in November 2015 (8). However, the first study site for the U.S. National Institutes of Health (NIH)–funded Zika in Infants and Pregnancy study was not activated until June 2016, and the European Union–funded ZIKAlliance did not enroll its first study participant until May 2017 (12).

In response to these barriers, in 2020, the U.S. National Institute of Allergy and Infectious Diseases (NIAID) established the Centers for Research in Emerging Infectious Diseases (CREID) Network, with the goal of enhancing global pandemic research response preparedness by building a sustainable, scalable, and adaptable infrastructure for EID research before, during, and after outbreaks. The inaugural Network comprised a central Coordinating Center (CC) and 10 Research Centers (RCs), with over 115 local research sites (RSs) in more than 30 countries where EID outbreaks are most likely to occur. Through the CREID Network infrastructure (see the Network’s research collaborators and site locations)¹, multidisciplinary teams of investigators collaborate to study EID pathogens of pandemic potential, identify critical research knowledge gaps that inhibit the development of prevention or mitigation strategies, and support critical research efforts to better understand the pathogen’s emergence, transmission, and overall outbreak evolution while performing enabling research to inform development of essential diagnostics and targets for potential medical countermeasures (i.e., vaccines and therapeutics).

Upon detection of a disease outbreak, many available human resources are applied to a public health response—prioritizing confirmation and treatment of cases as well as swift and effective control of an outbreak before it can expand to a geographic area that is too large to manage with available resources. To promote early identification of research needs and opportunities in the setting of an emerging outbreak, the CREID Network emphasizes the value of shifting capacity to coordinated outbreak research response (ORR) efforts—with an emphasis on the research component—to address key knowledge gaps of EID pathogens’ epidemiology, genetics, host interaction, and transmission dynamics. Since 2020, the CREID Network has promoted ORR efforts in more than 22 outbreaks of priority EID pathogens and pathogens of interest. These efforts have ranged from providing diagnostic and other research protocols to training in-country researchers in advanced analytical methodologies and supporting primary sample and data collection in observational cohort studies of humans, animals, and the environment.

Two years into the launch of the CREID Network, the capacities and expertise of the RCs and their network of global sites and investigators had been curated. However, there was still an opportunity to foster more meaningful and deeper levels of coordination and collaboration across this new research network. To address this need, during the CREID Network’s second annual program meeting, a tabletop exercise (TTX) based on a fictional outbreak simulation was conducted to encourage and build a collaborative Network community, share best-known practices and resource tools curated by the CC, and stress-test the CREID Network’s capacity to rapidly launch a coordinated research response for future outbreaks.

TTXs are group activities that use progressive simulated scenarios where TTX “Players” discuss and reflect on the impact of potential situations/scenarios on existing plans, procedures, and capacities (13). Through facilitated group discussions, they simulate an emergency in an informal, stress-free environment to strengthen preparedness to manage that emergency. TTXs are used to (1) develop or review a response plan; (2) familiarize Players with their roles and responsibilities; and (3) identify and solve problems through a facilitated and open discussion. TTXs have been used to prepare national and subnational government agencies, multi/bilateral organizations, and non-government institutions for emergencies such as epidemics or pandemics (14–16), floods (17, 18), and hurricanes (19). Their use to define the role of research in outbreak settings has been limited, however.

During the development of the CREID Network TTX, the cross-network planning team observed a lack of TTX resources specific to disease outbreaks, research responses, and multilateral coordination. Most existing resources were specific to public health management at a single institution engaging directly in an emergency or disaster response. This report provides an example of a TTX specific to pandemic research network preparedness and response involving international cross-institutional coordination and collaboration.

The primary outcome of the CREID TTX effort was to inform the development and adoption of a proactive framework for effective, timely, and responsive research when an EID outbreak occurs. To achieve this, the exercise was designed to help address the following aims (Figure 1): (1) assess CREID Network readiness for outbreak-related research and increase familiarity with Network tools and resources; (2) identify generalizable evidence gaps and research priorities; and (3) foster cross-Network relationship-building and engagement.

Figure 1

Tabletop exercise approach and deployment

The CREID Network’s TTX organization consisted of three phases, as detailed in Table 1: (1) a Strategic Planning Phase, where a cross-network TTX team was formed; (2) a Deployment Phase; and (3) an Analysis and Dissemination Phase to produce an After-Action Report to the Network’s leadership, membership, and sponsors.

A core planning team from the CREID CC and NIAID (Network sponsor) convened 9 months in advance of the TTX to define the TTX’s goal, aims, scope, structure, timeline, and evaluation metrics (Appendices A–E); the latter included questions to TTX participants whether the TTX had achieved its goals and aims (see Appendices B, E). Appropriate TTX deployment format and supportive tools, and the composition of TTX breakout groups (Facilitators, Reporters, Players, and Observers) were defined and aligned with CREID Network Working Groups (i.e., Laboratory Assays and Biorepository, Capacity Strengthening, ORR) (Table 2). The core team also developed a Facilitator’s Manual (Appendix A), used an interactive hybrid-amenable facilitation tool to steer the discussion and collect data on TTX evaluation questions (Menti®; Appendix B), and developed a reporting template (Appendix C) to capture standardized feedback during the simulation/exercise. Facilitators and Reporters for the TTX were academic research and faculty volunteers from the CREID CC and RCs, and were all trained by the core planning team to effectively carry out their roles and responsibilities and deploy facilitation and reporting tools when the TTX was conducted. Roles of TTX facilitators, reporters, players, support staff and observers are described in the Facilitator Manual (Appendix A).

The TTX was conducted at the NIAID hosted CREID 2022 Annual Program Meeting (September 2022, Towson, MD, USA) as two 2-h hybrid format sessions, with five concurrent breakout groups. There were 359 TTX “Players” from all 10 CREID RCs assigned to the breakout groups aligned with their CREID Working Group membership—there were 154 in-person attendees and 205 virtual attendees. Of participants, 50% were from the U.S., 8% from Asia (i.e., Cambodia, Hong Kong, India, Jordan, Malaysia, Myanmar, Nepal, Pakistan, Sri Lanka, Thailand, Vietnam), 23% from Africa (i.e., Democratic Republic of Congo, Cameroon, Ethiopia, Kenya, Liberia, Nigeria, Senegal, Sierra Leone, South Africa, Uganda), 5% from Europe (i.e., Belgium, France, Germany, Norway, Switzerland, United Kingdom) and 13% from Latin America (i.e., Argentina, Brazil, Ecuador, Nicaragua, Panama, Peru). Representatives from NIAID and other U.S. government agencies (i.e., Centers for Disease Control and Prevention; U.S. Agency for International Development) were Observers (Table 2).

The TTX was based on two sequentially released complementary scenarios, structured as Situation Reports (SitReps) (Appendix D), for a fictional outbreak of an unknown Pathogen X (modeled after Mpox). The first SitRep (#1) mimicked a typical disease outbreak report, where the outbreak was identified and clinical, epidemiological, and other information shared was incomplete. The second SitRep (#2) provided more complete clinical, epidemiological, and other information, including answers to questions that arose from the SitRep#1. In each session, Players were separated into their breakout groups to discuss responses to the SitReps. At the end of each session, Facilitators or Reporters summarized key takeaways and shared a breakout group summary report at a final all-hands session. More comprehensive descriptions of the TTX activities and two applied 2-h sessions (Days 2 and 3 of the meeting) are shown in Figure 2.

Figure 2

Responses to TTX evaluation questionnaires, data from applied session notes, and session summary reports were included in an After-Action Report (Appendix E) summarizing key findings and follow-up action steps from the TTX. Findings were presented to the CREID Network Steering Committee and used to update and streamline the Network ORR operational framework with enhanced communication materials, roles and responsibilities matrices, and real-time tracking and reporting of Network outbreak activity monitoring and engagement.

Observations, limitations, and recommendations

Why and how is this TTX, conducted in August 2022, of relevance almost 3 years later, and what were the most enduring lessons learned that are of value to all research centers and sites across the Network? The goal of the TTX was to foster more meaningful and deeper levels of coordination and collaboration across a new academic research network, as well as—due to the Network’s focus on EIDs—to stress-test the CREID Network’s capacity to rapidly launch a coordinated research response for future large-scale disease outbreaks. In this regard we believe that the goal is timeless, and we believe that the TTX approach described here would be of interest to a wide audience, whether affiliated with academic research networks like CREID, or to other stakeholders with an interest in EID outbreaks or health crises, such as ministries of health, multilateral/bilateral policymakers and donors, or the private sector.

Aim 1: Assess CREID network readiness for outbreak research response and member familiarity with network tools and resources

When discussing SitRep#1 and SitRep#2, TTX Players reviewed factors and variables that could challenge ORR efforts. They identified two key components that could be strengthened or improved to ensure effective and expeditious ORR: (1) strong internal and external partnerships and (2) familiarity with CREID Network resources designed to support ORR efforts.

Building and leveraging partnerships with external stakeholders (i.e., in-country ministries of health and other host government officials, academic research institutions, non-governmental organizations, multilateral/bilateral policy makers and donors, and private sector) in CREID-focus countries was a crucial factor highlighted by participants to foster an effective environment for collaboration in ORR. TTX Players acknowledged that it takes time to cultivate productive relationships and establish buy-in with in-country stakeholders for outbreak-related research, even in longstanding partnerships where these were to exist. As such, there was strong agreement that in-country relationship-building should be viewed as a foundational activity that begins well in advance of any EID outbreak. Specifically, the government ministries relevant to the One Health sectors of Health, Agriculture/Livestock, and Environment were consistently cited as the most important in-country relationships to cultivate. As noted by TTX Players, strong relationships with these ministries help ensure that CREID researchers are “at the table when an outbreak occurs, and the public health response is launched.” TTX Players further emphasized the importance of ensuring that in-country stakeholders are well-informed of the Network’s mission and capabilities. Additionally, TTX Players consistently cited the importance of ongoing efforts to build relationships within and between Network RCs and RSs. It was noted that creating these intra-Network connections before an outbreak will better position the Network to initiate a prompt and coordinated response when an outbreak does occur.

To assess the level of familiarity with processes and resources developed specifically for the Network, Players were asked about their familiarity with various resources that the CREID CC developed for the RCs and RSs to facilitate their CREID-supported research activities. Examples of available tools and resources include outbreak notification forms (i.e., to notify the Network of an outbreak of known or unknown etiology in a country where CREID operates), Network support request forms (e.g., for sharing of pathogen-specific assays and protocols), and pathogen factsheets (i.e., summary reviews of knowledge and research gaps of selected pathogens). However, familiarity with these tools among RCs/RSs seemed to vary (Table 3). This variable familiarity with available tools alerted the CC that a review of the tools, coupled with a renewed effort to increase tool awareness among Network RCs, may be necessary. Players also confirmed the need for additional resources that were under development at the time, such as country institutional maps and a virtual repository of Network-wide available biological reagents and specimens. New resources were also suggested, including an RS capacity directory, general human subjects research protocol templates with boilerplate language, best practices for handling and transporting samples and isolates, directory of in-country partners and stakeholders that may request assistance in the event of an outbreak, universal assay platforms, viral family-level surveillance/diagnostic reagents and kits (possibly combined in a “outbreak suitcase”), support for data analytics, guidance on how CREID RCs/RSs can be officially recognized by country Ministries of Health and other government entities, and guidance on immediate and unified communication about the Network with other stakeholders.

Aim 2: Identify EID evidence gaps and network research priorities

The TTX’s simulated Pathogen X outbreak was based on Mpox, with the goal of leveraging the TTX to facilitate development of a general roadmap for future Network engagement in critical research during a global multi-country outbreak. On Day 2, TTX Players were informed that Pathogen X was Mpox and were asked to consider potential evidence gaps and priorities for Mpox-related research. The Network could then use this information for strategic planning and resource allocation. However, the 70-min time frame that was allocated for the Applied Session B (Figure 2) did not allow for in-depth and exhaustive discussion. Additionally, although longer sessions during the annual meeting were not feasible due to Players joining from multiple time zones and having competing priorities, they should be considered in future TTXs. Instead, additional discussions continued outside of the TTX scope as part of ongoing Network ORR Working Group activities.

Although the intended goal for this aim was not achieved, the collaborative discussions generated important general recommendations to better position the Network to engage in future pathogen-agnostic ORR activities. This included the development of a list of critical research questions that should be considered for all EID outbreaks (Table 4). Network leadership uses this list to plan for research activities that could be conducted during inter-outbreak periods or rapidly launched at the start of an outbreak, including identification of facilitating resources and collaborative partnerships both within and outside the Network.

Aim 3: Foster cross-network relationship-building and engagement

Given the COVID-19 pandemic, the CREID 2022 Annual Program Meeting was the first opportunity for many Network members to connect with colleagues and collaborators from other RCs in person. Although most respondents said they did not personally know breakout group participants from other CREID RCs, all respondents reported they felt more comfortable interacting with CREID members from different RCs after the TTX—a change in behavior that likely was facilitated by CREID members meeting and actively interacting with one or more members of other RCs during the TTX.

Of 37 respondents, 84% (n = 31) said that they had learned something new about another RC or RS during the TTX, including their geographic presence, the scope of their research within and outside of the CREID Network, their linkages with government counterparts and other stakeholders, and general technical and operational capabilities. Similarly, two respondents specifically mentioned that they had been previously unaware of how some RCs had very close ties with Ministries of Health in various countries and how involved they were in their respective countries’ public health emergency response efforts.

Limitations, challenges, and recommendations

Several limitations were highlighted in the scope and application of this TTX. A major limitation of the exercise was that, as an exercise, it could not replicate the setting of an occurring EID outbreak. Sense of urgency, unanticipated circumstances, competing priorities, and politics are just some of the elements that are difficult to replicate in a simulation. Additionally, although an in-depth and exhaustive discussion was planned, the 70-min time frame that was allocated for SitRep#2 did not allow for it. Additionally, due to the hybrid nature of this TTX, with Players joining from multiple time zones, and competing priorities during the annual program meeting, longer sessions were not feasible, but should be considered in future TTX. Convening a 2–3 day TTX on its own may be costly, particularly for a research network spanning more than 30 countries—therefore, to minimize costs, the TTX was conducted during the already scheduled CREID Annual Partners Meeting.

After each TTX session, the Facilitators or Reporters of each breakout group summarized key takeaways, which were presented to all TTX participants at a final all-hands general plenary session at the annual program meeting. The feedback across all sessions informed key challenges to effective ORR and international collaborative research. The TTX highlighted several key technical and operational challenges faced by researchers engaged in ORR efforts. First, Biosafety Level (BSL) 3 and 4 and U.S. Select Agent requirements, as well as cold chain requirements dictate sample storage and processing locations, posing significant logistic challenges to conduct timely outbreak research. Second, limited data sharing and inadequate financial and human resources hamper pivoting from direct outbreak engagement (i.e., the public health response) to ORR. Third, there is a notable lack of member awareness about the capacities of other RCs, their RSs, and external stakeholder connections, which hinders timely and effective mobilization of existing capacities and resources across the Network. Fourth, the Network also faces challenges with proactive coordination and limited in-person interactions across its large global footprint, which often leads to reactive—rather than strategic—efforts being implemented. Table 5 summarizes key challenges, many Player recommendations, and high-level actions taken by Network leadership to address the recommendations. The rationale behind these recommendations is to help the CREID Network continue to grow and evolve to be a capable, experienced, and trusted EID pandemic preparedness and response stakeholder that can not only conduct critical outbreak-related or adjacent research to improve general knowledge on specific EID pathogens, but also complement and/or support an overarching public health response. Having internal and external linkages and relationships established prior to an outbreak may also facilitate the planning and implementation of ORR efforts. Additionally, in the event of an outbreak, Players noted that clear roles and responsibilities of engaged RCs and RSs in any ORR effort should be defined at the outset, to avoid overlapping efforts, misrepresentation, and miscommunication.

Post TTX: updated CREID network outbreak research response framework

The recommendations generated by the 2-day TTX laid the groundwork for the CREID CC to develop a revised and simplified CREID Network ORR Framework, as well as to develop and augment Network tools and resources to best meet the needs of the Network, NIAID, and global partners and stakeholders. Several of the tools and resources developed aligned directly with recommendations from the TTX (Table 5). The revised ORR Framework also builds on the experience and learnings from the first 3 years of CREID Network operations and comprises four key components: an outbreak dashboard, use of outbreak Tiger Teams, an outbreak toolkit, and a communications toolkit (Table 6).

Except for the Network Pathogen Surveillance Dashboard/Map Tool, all components of the CREID ORR Framework have been developed by the CC and launched on the CREID Private Web Portal to date. The ORR dashboard is live for Network members and contains detailed tracking records for EID outbreaks of relevance to the Network. For outbreaks occurring in more than one country with multiple RCs engaged, Tiger Teams were established to coordinate ORR activities within the Network. The teams are multidisciplinary teams with representation from the RCs/RSs, NIAID/DMID, and CC, that are formed to create a separate space for engaged RC/RSs to communicate, share knowledge, and find points for research collaboration in the rapidly evolving landscape that EID outbreaks typically represent. The teams focus on the research response that may be needed or could occur during an EID outbreak to answer critical pathogen knowledge gaps. The Tiger Teams are not necessarily intended to directly contribute to reduce or control incidence/spread—this is a function that sits squarely with countries’ ministries of health and public health response stakeholders. As of October 2024, four Tiger Teams have been created: Sudan ebolavirus disease in Uganda (2022), Marburg virus disease in Equatorial Guinea and Tanzania (2023), Aedes-borne diseases in Latin America (2023), and Oropouche virus in Latin America (2024). Key components of the outbreak toolkit have been developed, including 20+ institutional mapping briefs for countries the CREID Network operates in, a virtual specimen and reagent BioDirectory for efficient material identification and sharing among RSs, human subject protocol templates, and best practices guidance for sample and data sharing. Furthermore, research roadmaps for chikungunya and Lassa fever were developed, and those for Rift Valley fever and Crimean-Congo hemorrhagic fever are currently under finalization. The communications toolkit for the framework was completed in May 2024 and uploaded to the CREID Private Web Portal’s Resource Library. The toolkit includes an updated Network brochure, key talking points and media guidance, and standardized presentations to introduce the CREID Network to external partners and stakeholders. The revised CREID Network ORR Framework will help facilitate Network member engagement with critical external collaborators and improve central coordination within the Network by providing mechanisms to leverage cross-RC or cross-RS synergies, avoid duplication of efforts, and conduct impactful research in response to outbreaks of priority pathogens and pathogens of interest.

Conclusion

Through the use of a TTX, the CREID Network was successful in fostering stronger cross-Network relationships and assessing network readiness for research in the setting of EID outbreaks. Researchers from various regions who had been communicating online for 2 years due to the COVID-19 pandemic were finally able to meet in person at the CREID 2022 Annual Program Meeting where the TTX was conducted. The TTX underscored the need for closer relationships with government ministries that would allow them to see the CREID Network as an available research partner as well as the need for more suitable Network tools and resources that fit the needs of the in-country research teams. Although EID pathogen-specific evidence gaps and research priorities were not specifically identified, the participants were successful in narrowing down a list of critical pathogen-agnostic research questions that would be beneficial across the Network to capture key information that might have previously been overlooked and to standardize data collection processes across collaborating RSs. The CREID CC used the TTX feedback and findings to inform a revised Network ORR Framework, which was developed and implemented in the middle of Year 3 of the Network’s 5-year performance period.

The TTX approach described in the manuscript, as well as the materials developed post-TTX could serve as a reference for similar research networks and organizations to play out various scenarios to help them prepare for and ultimately respond to an emergency, such as a large-scale disease outbreak or even pandemic. The benefit of working within a network structure such as CREID is the ability to leverage capacities at various institutions for strategic planning and efficient resource allocation. From prior major EID outbreaks, including the COVID-19 pandemic, we have seen that outbreak responses typically start out as being reactive—however, proactive and coordinated engagement is required to prevent further pathogen spread. Challenges identified and solutions discussed during and after the TTX helped the CREID Network to apply a more proactive and forward-looking approach to engage in coordinated, collaborative, and impactful global outbreak-related EID research.

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