bluuebunny/crossref_metadata_2025_split huggingface dataset:
18 Good Participatory Practice: Social Mobilization, Communications, and Community Engagement
Authors: Sorenson Robert A. , Delph Yvette , Wilson Bartholomew , Fallah Mosoka P. , Higgs Elizabeth S. 
Published: August 2024

Abstract
Good participatory practice (GPP) is a set of procedures to ensure all stakeholders in a clinical trial have a voice in the research process. It is rooted in the ethical imperative to treat people as ends in themselves, rather than mere means. It is also a necessity for research programs to engender participant and community trust in clinical research and ultimately in the safety and efficacy of medical countermeasures (MCMs) validated by clinical trials. GPP requires systematically reaching out to all stakeholders who are affected by or can influence the research in question, listening to them, and making changes to the way the trial team interacts with stakeholders if needed. Genuine dialogue with stakeholders about the principles of clinical research and why it is being conducted in their community is the basic principle. As well as GPP, this sort of engagement is known by different names in various places: in sub-Saharan Africa, it is often referred to as social mobilization, communication, and community engagement (SMC).
While GPP/SMC should be part of all clinical research efforts, it must be part of an emergency research response. When populations are under stress from an emerging infectious disease and its disruptive social consequences, their active participation in the research; their understanding of its purpose, goals, and process; and their confidence in research integrity, ethics, and oversight are pragmatic as well as normative requirements. Without community backing, a research program may not be feasible, and if the research identifies an MCM as safe and efficacious but it is not used for lack of confidence, then it does little good. GPP must be tailored to circumstances, including the pathogen causing the outbreak, the dynamics of the disease, and the type of study. It should be responsive to feedback from stakeholders so as to refine messaging content and format, adjust procedures, and effectively communicate both successes and obstacles. Fruitful dialogue requires understanding the communities, languages, and cultures involved. Effective GPP strengthens those communities and other stakeholders and contributes to enhanced healthcare and research capacity. To illustrate these themes, this chapter explores some common patterns evident in different times and places, such as the 2014–2016 Ebola outbreak in West Africa and the coronavirus disease 2019 (COVID-19) epidemic.
18.1 In Practice: Building Community Engagement for Clinical Research Response
Authors: Andrasik Michele , Broder Gail , Oseso Linda , Segura Patricia , Baepanye Kagisho , Kamel Luciana , Michael Nelson 
Published: August 2024

Abstract
This in-practice text provides examples of progressive community engagement that lays the groundwork for an emergency clinical research response in case of need. Community engagement via good participatory practice (GPP) enables sharing information and perspectives among community members, researchers, research sponsors, and other stakeholders throughout the clinical trial lifecycle. It builds and maintains relationships and partnerships between the research team and the wider community through bidirectional communication and reciprocity. Real-world examples of community engagement include the Transcrições Art Project for fostering relationships with transgender women in Rio de Janeiro, which played a role during the COVID-19 pandemic, and the CEPAD HIV testing center in Buenos Aires. Real-world examples of meaningful community involvement also include the COVID-19 Prevention Network (CoVPN), with clinical research sites in South and Central America, southern Africa, and the United States. The sites have been active in reducing misinformation and disinformation about COVID-19. In the United States, southern Africa, and South America, full-time network staff provide technical assistance and capacity building to sustain community engagement efforts at clinical research sites. GPP is vital to preparedness and requires additional attention and support if it is to be optimized for pandemic response, as shown by the examples given.
18.2 18.2 In Practice: Adapting Social Analytics for Research Response
Authors: O’Neill Rhys , Cyprian David , Higgs Elizabeth S. 
Published: August 2024

Abstract
Social analytics had its genesis in the defense and communication sectors. At the outset of the 2014–2016 West Africa Ebola outbreak, social analytics techniques were adapted and modified to support social mobilization, communication, and community engagement (SMC) efforts in Liberia. The experience demonstrated that social analytics provides a powerful tool for understanding community beliefs, identifying trusted sources of information, monitoring rumors, and public understanding (or not) of research and response interventions. Utilization of social analytics techniques has been increasing; for example, supporting the Democratic Republic of the Congo (DRC) during the large 2018–2020 Ebola virus disease (EVD) outbreak in its eastern provinces, as well as in COVID-19 vaccination efforts, and more recently in support of WHO AFRO.
Social analytics can often be misconstrued as social media monitoring, but effective social analytics requires comprehensive “listening”; a holistic approach to available social data, including online content, news and broadcast content, field research; and, perhaps most distinctively, local, on-the-ground experts knowledgeable about the social and cultural context. Social analytics must thus be used to gather and analyze data close to operational teams. Societal and community beliefs can vary between neighboring communities, and it should never be assumed that one community will react to events or messages the same way as others. Beliefs and attitudes also change throughout a health emergency. Therefore, social analytics must be geographically precise and updated weekly to stay current and inform effective disinformation countermeasures and risk communications. What began as work with NIAID on a single outbreak in West Africa has evolved into a powerful tool for informing communication, messaging, and dialogue with communities and broader populations during health emergencies. Social analytics is now an established, powerful tool for assisting social mobilization committee (SMC) pillars, research sponsors, and host governments as they respond to health emergencies.
19 Understanding and Reporting the Natural History of an Infectious Disease
Authors: Crozier Ian 
Published: August 2024

Abstract
Accurate characterization of the natural history of a disease is often inadequate in outbreaks of novel or re-emerging infectious diseases. Through the lens of the host–pathogen–care interface, the stages, outcomes, and determinants of the natural history are considered, with emphasis on how the natural history might suggest interventions to improve acute and convalescent outcomes. Understanding the natural history directly informs not only clinical care but also preclinical development and discovery of medical countermeasures and sets the stage for design of high-quality clinical trials of the same. Conducting optimal natural history studies is challenging during an infectious disease emergency; strategies to enhance understanding and report natural history as part of the emergency research response are discussed.
21 Epidemiologic Research in the Setting of Outbreak Response
Authors: Reingold Arthur 
Published: August 2024

Abstract
The highest priority during the response to an outbreak or epidemic is to limit morbidity and mortality by preventing new cases and improving outcomes in those who are affected. Epidemiologic research is an essential component of such a response. Well-designed and rapidly executed observational epidemiologic studies, often done in conjunction with laboratory and environmental investigations and informed by relevant behavioral and social sciences knowledge, can help guide the development and implementation of interventions that ameliorate the current outbreak, as well as contribute to more effective and earlier responses to future outbreaks. While generic, “off the shelf” protocols for studies of some recurring, outbreak-prone infectious diseases (e.g., cholera and influenza) may help expedite such studies, they are no substitute for well-trained, experienced epidemiologists who are available for rapid deployment wherever and whenever they are needed to plan and carry out such studies. Experience with recent epidemics and pandemics caused by a wide range of infectious disease agents (e.g., Ebola, Zika, severe acute respiratory syndrome [SARS or SARS-1], influenza, and coronavirus disease 2019 [COVID-19]) illustrates the central contribution of observational epidemiologic studies to enhanced understanding of and improved response to both new and old infectious disease threats. Following the COVID-19 pandemic, there will be considerable investment, at least in the short term, in accelerating outbreak response research, including its epidemiologic dimensions. Assuring that such research is thoughtfully designed and carefully implemented is a high priority.
22 Vaccine Trial Designs
Authors: Kahn Rebecca , Villar Sofia S. , Dean Natalie E. , Lipsitch Marc 
Published: August 2024

Abstract
Vaccine efficacy trials conducted during epidemics of emerging infectious diseases have three main objectives: (1) to test the null hypothesis in a rigorous fashion, (2) to estimate the efficacy of the vaccine candidate, and (3) to maximize the trial’s public health impact. All of these objectives create urgency for planning and implementing vaccine trials. Ideally, a preferred design choice, based on the anticipated aims of a trial, should be chosen as early as possible. Here we discuss five key choices that must be made in trial design: (1) randomization unit, (2) comparator intervention, (3) trial population, (4) trial implementation, and (5) primary endpoint. We examine each of these choices in the context of each of the three objectives. We also describe the opportunities and challenges of employing adaptive designs for vaccine trials. Where possible, simple, familiar designs should be chosen to make the trial easier to conduct, results easier to interpret, and authorization or approval easier to obtain. However, in some circumstances, innovative designs may be called for, and having preapproved protocols with adaptive elements incorporated can help expedite such trials during an outbreak. The contrast between vaccine trial conditions and choices during the West African Ebola outbreak and the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is a reminder of the unique challenges arising in each infectious disease emergency and the importance of these conditions in guiding trial design.
22.1 In Focus: Ring Trial Design
Authors: Dean Natalie E. , Longini Ira M. 
Published: August 2024

Abstract
This focus article explains the origins, design, and rationale behind the ring trial design for clinical medical countermeasure (MCM) research, especially in an emergency response setting. In a ring trial, individuals linked to a newly diagnosed infectious disease case are recruited and randomized as a cluster or individually within the ring to an intervention such as vaccination or a control arm. The advantages and disadvantages of the ring trial design are outlined, and the Ebola ça Suffit! vaccine ring trial in Guinea is provided as an illustration. Considerations for an appropriate study design and potential modifications to the design, such as amending the definition of a ring, are described. The ring trial design has great potential for future applications to evaluate fast-acting interventions in settings where spatiotemporal disease incidence is highly unpredictable and infection is relatively rare. Such an approach has the potential to accelerate the accrual of critical results in emergency response research.
23 Data and Safety Monitoring of Clinical Trials During Public Health Emergencies
Authors: Proschan Michael A. , Grund Birgit 
Published: August 2024

Abstract
Public health emergencies present special challenges in the monitoring of clinical trials. There is tremendous pressure to find effective treatments as quickly as possible without jeopardizing the integrity of results. Frequent early monitoring from an experienced data and safety monitoring board (DSMB) is required to ensure patient safety, especially when novel or repurposed interventions may be tested earlier than they would be in a nonemergency setting. This chapter begins by reviewing general monitoring, including the purpose, composition, and operation of DSMBs, efficacy monitoring boundaries, tools such as conditional power and predicted interval plots for judging whether continuation of a trial is futile, and practical aspects of monitoring clinical trials. We offer important historical examples, like the Cardiac Arrhythmia Suppression Trial (CAST), as well as more recent examples specific to infectious disease, such as the Adaptive COVID-19 Treatment Trial (ACTT-1). We highlight the special challenges posed by monitoring clinical trials in public health emergencies and illustrate these with a case study of the Partnership for Research on Ebola Vaccines in Liberia (PREVAIL-I) vaccine trial in West Africa. We conclude with important lessons learned.
24 Mathematical Modeling for Emergency Response: Using Models to Inform and Direct Response Priorities and Shape the Research Agenda
Authors: Greening Bradford , Meltzer Martin I. 
Published: August 2024

Abstract
Mathematical modeling has become an essential component of planning for and responding to infectious disease outbreaks and other threats. Modeling can provide insights into possible scenarios when there are insufficient data for statistical analysis to produce solid guidance for decision-makers, allowing them to, for example, undertake immediate response for the most likely outcomes and begin contingency planning for worst-case scenarios. Good modeling depends on using experience and well-tested models and bringing in new data as they become available in a continuous process of refinement. Modeling can provide a sense of the interventions needed, the magnitude of required response, and what leadership needs to convey to the health care system and the broader population. An introduction to the main types of models used in infectious disease response follows, along with a summary of how to communicate the results to decision-makers. A worked example allows readers to follow along with the development of a modeling and information process. Modeling cannot produce predictions in the absence of essential data, but it can provide guidance on what could happen, and do so with increasing reliability as more data on the complex interactions between a pathogen and human populations become available.
28 Financing Emergency Research Response During Infectious Disease Outbreaks: Lessons from the World Bank and Other International Financial Institutions
Authors: Pate Muhammad Ali , Bali Sulzhan 
Published: August 2024

Abstract
Recent infectious disease outbreaks have stimulated multiple institutional and operational efforts by governments, international organizations, and the private sector to ensure the world is better prepared to respond to epidemics. One of the critical advances has been the greater engagement of international financial institutions (IFIs) in supporting preparedness for and response to emerging and re-emerging infectious diseases (EIDs) with epidemic potential. Despite progress on preparedness and response, including the launch of initiatives such as the Coalition for Epidemic Preparedness Initiatives (CEPI), the world is not well prepared for the next pandemic, and research and development (R&D) for medical countermeasures against EIDs requires more attention, coordination, and investment. IFI investments in health security have so far focused primarily on disease surveillance, laboratory capacity, outbreak readiness, and human resources for health security, under initiatives that have not so far included sufficient focus on R&D for preparedness and accelerated development of new vaccines, therapeutics, and diagnostics (VTD) against novel pathogens.
This chapter examines how IFIs can better contribute to the advancement of EID preparedness and response. It describes IFI initiatives, including those by the World Bank, that complement other global efforts to galvanize emergency research during EID outbreaks. IFI initiatives seek to strengthen national and regional infectious disease response systems. Through IFI financial management expertise, leveraging IFIs’ comparative advantage in fund management services and their use of development lending, IFIs also seek to bolster core capacity at the intersection of health systems and clinical research. This chapter also notes some constraints faced by IFIs in financing clinical research and examines lessons and opportunities for IFIs to accelerate investment in emergency research.
30 Organizational Partnerships for Preparedness and Response to Emerging and Re-emerging Infectious Diseases
Authors: Yazdanpanah Yazdan , Madelaine Claire , Pulik Nicolas , Souteyrand Yves 
Published: August 2024

Abstract
International crises demand active formation of health research partnerships, which are collaborative relationships between two or more parties for the common goal of improving the health of populations through mutually agreed functions and principles and sharing of risks and benefits. Key partnership players include communities, national authorities and health systems, research organizations, academic centers, non-governmental organizations (NGOs), pharmaceutical companies, international funders, policymakers, and the World Health Organization (WHO). The greatest strength of these partnerships is their ability to combine the complementary strengths of different stakeholders to achieve common objectives. To improve pandemic preparedness and the capacity for prompt responses to emerging infectious diseases, the chapter recommends enhancing partnerships, embedding international R&D efforts into national health systems; providing appropriate research funding; developing and strengthening human resources, communication, infrastructures, and surveillance; and translating science into policy decisions.
30.2 In Practice: Building and Maintaining Preparedness for a Rapid Research Response in Indonesia
Authors: Lau Chuen-Yen , Grue Louis , Neal Aaron , Karyana Muhammad 
Published: August 2024

Abstract
Existing international research partnerships, bilateral or multilateral, are a crucial building block of research response preparedness. The long-standing partnership between the Indonesia Ministry of Health and the U.S. National Institute of Allergy and Infectious Diseases, known as INA-RESPOND, demonstrated the value of such preparedness through its early contributions to the diagnosis of and research on coronavirus disease 2019 (COVID-19) in early 2020. Building on such partnerships is essential preparation for the next potential pandemic, especially in parts of the world where animal species diversity; close contact among humans, livestock, and wild fauna; and land use changes make the spillover of novel zoonotic pathogens most likely. INA-RESPOND has also demonstrated its capacity to work with other partners, like the World Health Organization and universities in Australia, thus making it an internationally linked node in a global framework that may be the best hope for preventing the next pandemic.
4.1 In Practice: Vaccine Efficacy and Safety Testing—An Ethical Case for Individual Randomization
Authors: Eyal Nir , Lipsitch Marc 
Published: August 2024

Abstract
A scientific trial has individually randomized control when the intervention or control status for each participant is independently chosen at random at the start of the trial. That is in contrast to cluster randomization, where this status is determined for groups of participants, and in contrast to trials without randomization and to non-trial methods of assessing experimental interventions. The individually randomized controlled trial is generally the most effective and thus the most ethical trial design for assessing the safety and efficacy of candidate vaccines against infectious disease. With this trial design, all study participants benefit by receiving protections that other people at similar risk of infection often do not receive. These benefits include close monitoring, enhanced clinician–patient ratios, and the opportunity to be randomized to the preferred arm of the study. Furthermore, individually randomized trials for emergency response usually reach any given level of statistical confidence before alternative designs with group randomization. Individual randomization is also compatible with delayed or active control trial designs, parallel or stepped rollout, a variety of primary endpoint trial population choices, and either environmental or challenge exposure to the pathogen.
33.3 In Practice: Capacity Building for Research Ethics Review in Low- and Middle-Income Countries
Authors: Sina Barbara , Tierney John 
Published: August 2024

Abstract
All research with human participants must undergo ethical review by a research ethics committee with jurisdiction over the location of a proposed research study. Recent global infectious disease outbreaks have exposed shortcomings even in otherwise well-functioning ethical review systems in developed countries when they must meet the urgent demands of outbreak research. Moreover, relatively little global health research funding and resources have supported development of research ethics review system capacities in low- and middle-income countries. Countries with less robust ethics review systems and limited current support, less pertinent expertise, and lower administrative capabilities have been even more affected by emergency outbreaks. To be better prepared for the next outbreak or other public health emergencies, research partners must make every effort to support sustainable development of local resources and institutions, oversight of ongoing research, and review of new research proposals. This chapter will concentrate on three areas: (1) evaluation of existing research ethics review capacity, (2) partnering and exchange to immediately address gaps and needs, and (3) developing future research infrastructure and capacity to ensure epidemic ethics preparedness.
37 Supply and Logistics for Clinical Research in Low-Resource Settings
Authors: Baseler Beth , Proffitt Calvin , Sandrus Jen , Marchand Jonathan , Stavale Eric 
Published: August 2024

Abstract
Providing continuous logistical support for clinical research sites is a critical function of any clinical research study, one that is substantially more challenging for an emergency research response in a resource-limited setting. This chapter provides an overview of the planning considerations involved, as well as a discussion of specific functions like partnership development, export and import, transportation, supply and equipment management, and hiring in-country staff to provide logistical support. The chapter includes multiple potential solutions, since more than one approach, as well as flexibility and creativity, are generally needed to keep a scientific research operation running in an infectious disease emergency—especially where resources are scarce and the populace distressed by fear and concern for themselves and their families.