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Considerations for Use of Investigational Drugs in Public Health Emergencies.

ABSTRACT: The paradigm for the use of investigational drugs in public health emergencies has been recently tested to prevent and treat highly infectious and lethal diseases. Examples include the successful implementation of vaccine and therapeutic clinical trials during the recent Ebola outbreak in West Africa. On the other end of the spectrum was the Emergency Use Authorization (EUA) of peramivir in the treatment of H1N1 influenza virus that did not provide an opportunity to collect data or understand the effectiveness of the EUA program. Between the gold standard of a randomized controlled clinical trial and the problems associated with EUAs are the domain of expanded access protocols that may provide an avenue to make products available while awaiting licensure. This paper will examine the regulatory pathways in the United States (US) for the use of investigational drugs in a public health emergency as well as considerations when making these products available outside the US. Descriptions of the applications of the various approaches will be presented. Regardless of the pathway chosen, public health and clinical research planners need to work together to consider several factors associated with the respective options and maintain a goal of working toward the collection of data to support licensure before faced with future outbreaks. Finally, this paper will consider the lessons learned from public health response in the context of investigational drugs in other diseases where "right to try laws" may pose opportunities, as well as challenges.

SUBMITTER: Kirchoff MC

PROVIDER: S-EPMC5486404 | biostudies-other | 2017 Mar

REPOSITORIES: biostudies-other

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Considerations for Use of Investigational Drugs in Public Health Emergencies.

Kirchoff Matthew Carl MC Pierson Jerome F JF

Therapeutic innovation & regulatory science 20160101 2

The paradigm for the use of investigational drugs in public health emergencies has been recently tested to prevent and treat highly infectious and lethal diseases. Examples include the successful implementation of vaccine and therapeutic clinical trials during the recent Ebola outbreak in West Africa. On the other end of the spectrum was the Emergency Use Authorization (EUA) of peramivir in the treatment of H1N1 influenza virus that did not provide an opportunity to collect data or understand th ...[more]

PMID: 28663940

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Project description:Background The global COVID-19 pandemic has posed a major threat to human life and health, and new media technologies have intensified the spread of risk perception. Purpose This study aimed to explore the impact of risk information ground on online users’ perceived health risks, and further explore the mediating role of psychological distance and the moderating role of self-efficacy. Methods A total of 25 Internet users from different provinces in China were interviewed in-depth, NVIVO.11 was used to qualitatively analyze the interview text data and construct a theoretical model. A total of 492 interviewees were recruited in order to complete a scenario questionnaire, SPSS-27 was used to perform orthogonal experiments, generate eight combinatorial scenarios, analyze demographic data, and clean and prepare data for testing hypotheses. SmartPLS 3.0 was used to test the conceptual model using the structural equation model (SEM) of the partial least squares (PLS). Results The analysis of the SEM model shows that all planned hypotheses (Information fluency → Information diagnosability, Information extensibility → Information diagnosability, Information diagnosability → Psychological distance, Platform interactivity → Scenario embeddedness, Network connectivity → Scenario embeddedness, Scenario embeddedness → Psychological distance, Psychological distance → Risk perception, Psychological distance → Self-efficacy → Risk perception, Information fluency → Information diagnosability → Psychological distance → Risk perception, Information extensibility → Information diagnosability → Psychological distance → Risk perception, Platform interactivity → Scenario embeddedness → Psychological distance → Risk perception, Network connectivity → Scenario embeddedness → Psychological distance → Risk perception) are confirmed. Conclusion This study found that the information ground factors significantly affect online users’ perceptions of health risks, psychological distance mediates the effect of information ground factors on risk perception, and self-efficacy negatively moderates the effect of psychological distance on risk perception.

Project description:BackgroundNatural and human-made public health emergencies (PHEs), such as armed conflicts, floods, and disease outbreaks, influence health systems including interruption of delivery and utilization of health services, and increased health service needs. However, the intensity and types of impacts of these PHEs vary across countries due to several associated factors. This scoping review aimed to synthesise available evidence on PHEs, their preparedness, impacts, and responses.MethodsWe conducted a scoping review of published evidence. Studies were identified using search terms related to two concepts: health security and primary health care. We used Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews (PRISMA-ScR) guidelines to select studies. We adapted the review framework of Arksey and O'Malley. Data were analyzed using a thematic analysis approach and explained under three stages of PHEs: preparedness, impacts, and responses.ResultsA total of 64 studies were included in this review. Health systems of many low- and middle-income countries had inadequate preparedness to absorb the shocks of PHEs, limited surveillance, and monitoring of risks. Health systems have been overburdened with interrupted health services, increased need for health services, poor health resilience, and health inequities. Strategies of response to the impact of PHEs included integrated services such as public health and primary care, communication and partnership across sectors, use of digital tools, multisectoral coordination and actions, system approach to responses, multidisciplinary providers, and planning for resilient health systems.ConclusionsPublic health emergencies have high impacts in countries with weak health systems, inadequate preparedness, and inadequate surveillance mechanisms. Better health system preparedness is required to absorb the impact, respond to the consequences, and adapt for future PHEs. Some potential response strategies could be ensuring need-based health services, monitoring and surveillance of post-emergency outbreaks, and multisectoral actions to engage sectors to address the collateral impacts of PHEs. Mitigation strategies for future PHEs could include risk assessment, disaster preparedness, and setting digital alarm systems for monitoring and surveillance.

Dataset Information

Considerations for Use of Investigational Drugs in Public Health Emergencies.

Publications

Considerations for Use of Investigational Drugs in Public Health Emergencies.

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