Shelley McLendon, SVP of Vaccine and Infectious Diseases Program Management at ICON, attended the World Vaccine Congress Europe from 16-19 October 2022 in Barcelona, Spain. There, McLendon spoke on the topic of fortifying vaccines against future pandemics, specifically discussing: The importance of disease surveillance and reporting with regard to emerging infectious diseases; promising developments in early outbreak detection; and the role of smart data reporting and adaptive trial designs in the clinical trial process. Since then, she has shared with DDW exclusive insights on the topic.
Disease surveillance and reporting
Disease surveillance is the collection and monitoring of data on disease within a population. This helps to assess the health of populations, and gather information on what diseases are present and in what numbers. Reporting disease information to appropriate authorities or organisations enables the analysis of data to better understand disease patterns and trends and identify outbreaks early.
The benefits with regards to emerging infectious diseases
Emerging infectious diseases (EIDs) move quickly, and it can be difficult to predict when and where they will spread. Fast and effective surveillance and reporting are critical to responding quickly to new outbreaks. This not only has public health ramifications, but also impacts vaccine efficacy trials, which hinge upon active transmission of a disease within a population to gather meaningful data. Surveillance data can inform where and when to conduct these trials — and the faster it is available, the more likely vaccine trials can quickly mobilise while an outbreak is still underway.
For instance, responsive clinical trials can use surveillance data to identify geographic areas and communities that are at high risk for disease. The sponsors conducting these trials can then respond to surveillance data from those areas in real time, allowing trial sites and enrolment to be activated as disease transmission occurs. Ring trials, which identify and vaccinate all the contacts of an individual confirmed to be infected with the target disease, are an excellent example — and were used during the 2014-2016 West African outbreak of Ebola (considered an EID) to test the efficacy of a novel Ebola vaccine.
Key learnings by countries and governments from Covid-19
Some countries do seem to have learned the importance of disease surveillance. For example, as part of the American Rescue Plan of 2021, the United States (US) established the Center for Forecasting and Outbreak Analytics. This initiative addresses the country’s outdated public health data system, making it easier to share and analyse disease information in a timely, meaningful way.
Promising developments in early outbreak detection
Wastewater surveillance is a promising development that has been put to the test during the COVID-19 pandemic. Using wastewater to detect the presence or prevalence of a pathogen in human stool and other waste has an advantage over many other forms of diagnosis, as it does not rely on testing every individual in a community for accuracy. The National Wastewater Surveillance System, launched in September 2020, has worked with local health departments across the US to track levels of SARS-CoV-2 in their communities. Because wastewater surveillance can be an early indicator that COVID-19 cases are rising or declining in a given area, this has enabled preparation and quick responses. The same technology is also being used in some areas to monitor the presence of other pathogens, such as RSV and poliovirus.
Obstacles standing in the way of its full potential
To make the best use of disease surveillance and reporting, it must be consistently conducted in numerous locations around the world. For many low- and middle-income countries, access to necessary equipment and trained staff is uncertain. Particularly in rural and agricultural settings where risk of exposure to zoonotic disease is higher, it is important to expand diagnostic and clinical capacity and resources.
Additionally, to fully take advantage of the opportunity that surveillance provides for vaccine efficacy trials, institutional trust must be restored. The over-politicisation and the spread of false information relating to vaccines may increase the difficulty of recruiting participants for clinical trials, which is particularly concerning when speed is of the essence.
The importance of smart data reporting
Smart, effective data reporting is what enables the aggregation, access and analysis of epidemiological information. On the local and regional level, smart data reporting informs vaccine efficacy trial implementation and site selection. Additionally, reliable and centralised data reporting can play an integral role in providing the information needed to develop vaccines for EIDs. In the case of Covid-19, researchers lost invaluable time in January and February 2020, as they were only able to access and analyse scraps of data from official reports, newspaper articles and social media posts.
Adaptive trial designs in the clinical trial process
Adaptive trial designs provide a plan to modify elements of a trial depending on the data it generates. An adaptive trial will conduct periodic, scheduled analyses of trial data, and adjust trial elements according to predetermined criteria. Examples of these changes include refining sample size, abandoning treatments or doses, or stopping the trial early if success or lack of efficacy is clear. This allows vaccine trials to be more efficient by providing the flexibility to reduce the number of needed participants or resources, as well as saving time and money.
About the author
Shelley McLendon has more than 25 years of clinical research experience, 19 of which are tenured at ICON. McLendon provides executive leadership and oversight for ICON’s clinical and project management teams in the implementation and execution of vaccine and infectious disease clinical development programmes. She also consults with small to mid-size biotechnology clients and large pharmaceutical companies providing strategic operational guidance and driving partnership development.
