The global healthcare sector has witnessed both unprecedented challenges and achievements over the past few years, most notably during the pursuit of the COVID-19 vaccine in 2020-21. The accelerated development of that vaccine not only achieved timeline speeds previously thought unattainable, but also reshaped the landscape for clinical trials across the spectrum of infectious diseases.
According to GlobalData’s Clinical Trials Database, there are currently 723 clinical trials for infectious diseases planned for 2024 – with potentially more to be announced. Nevertheless, these figures are significantly down from the 4,311 infectious disease trials that started between 1 January 2021 and 31 December 2021, when much of the pharma industry was focused on trialing vaccines for COVID-19.
Compared with pre-pandemic levels, the current 2024 figures are also lower than the 2,062 infectious disease trials recorded by GlobalData that started between 1 January 2019 and 31 December 2019, the 3,157 trials recorded in 2018, or the 2,910 trials counted in 2017. This could be a sign that budget restrictions from sponsors and pharma companies are decreasing the number of clinical trials in the infectious disease space.
There is a significant focus this year on trials for infectious diseases with global impacts, such as COVID-19, HIV/AIDS, hepatitis B, and malaria. The most common 2024 clinical trials also highlight the variety of indications being researched, from viral and bacterial infections to sepsis and the long-term effects of COVID-19.
With the diversity and breadth of these infectious disease clinical trials being undertaken, how are they being affected by the precedent set by COVID-19? And how do we expect to see this influence impact trends in 2024?
1. Accelerated development and regulatory adaptation
One of the most significant shifts observed since the onset of the pandemic is the accelerated pace of vaccine and therapeutic development. In fact, COVID-19 vaccines were the fastest vaccines ever to reach the market, from inception through to patient availability. One key to delivering on those accelerated timelines was the ability to adapt and change. Vaccine research is highly dynamic, especially with an evolving infectious disease like COVID, and the ability to adapt research on the fly was critical to success.
Regulatory bodies such as the FDA and EMA also adapted by introducing more flexible, fast-track approval processes for treatments showing promise against infectious diseases. This agility, both in the development and the regulatory process, has not waned; rather, it has become a key tool in the fight against emergent and re-emergent infectious threats. In fact, 2023 was a record year for FDA approvals, with an estimated 65% of the 71 new drugs receiving approval from the accelerated pathways.
2. Global collaboration and data accessibility
The pandemic also underscored the importance of global collaboration and data sharing in addressing infectious diseases – notably in COVID-19 vaccine development with Pfizer-BioNTech, and AstraZeneca’s partnership with the University of Oxford – fostering a more cooperative approach to clinical trials.
The ways of executing data sharing to support these alliances and the trial-level collaboration also evolved due to the pandemic. There was an increased desire for platform-driven solutions that support faster, more effective decision-making. The sharing of data, resources, and best practices has been proven to accelerate the pace of disease discovery and the application of findings across borders.
3. The integration of digital and AI
Artificial intelligence (AI) and digital solutions are poised to play increasingly pivotal roles in clinical trials for infectious diseases. From patient recruitment and retention to data analysis and monitoring, these technologies offer opportunities to streamline processes, enhance accuracy, and uncover insights that might elude traditional methodologies.
The integration of AI can also predict outbreaks and model the potential effectiveness of treatments, shaping the future of preventive and therapeutic strategies. In addition, AI combined with machine learning will quickly prove essential for improving operational efficiency; for example, study managers dealing with medical coding.
“Using AI in our medical coding, we can get though the volume more quickly but also more intelligently,” states David Provenghi, Director of Clinical Data Management. ProSciento
Decentralized clinical trials (DCTs) and hybrid trials have gained popularity in recent years due to their innovative approach to conducting clinical research. These trials utilize digital solutions to facilitate various trial activities remotely, including recruitment, enrollment, data collection, and follow-up, thereby removing geographical constraints and making trials more accessible to participants regardless of location.
The popularity of DCT solutions has been driven by their ability to make clinical trials more patient-centric, allowing for more inclusive and diverse participant populations – and they played a critical role during the pandemic to overcome restrictions on travel and the ability to visit medical facilities for in-person visits.
“Infectious disease trials are by nature challenging because your recruiting pool is bigger, and you’re dealing with a lot more variability within the participants. This results in a broader, more dynamic set of folks, compared to research into something like cancer treatment,” explains Walker Bradham, Senior Director of Product Management & Design for Zelta. “It’s important to consider deploying DCT methodologies because they’re proven to keep study participants more engaged, but it requires cost-effective, flexible tools that allow you to deploy and adapt your data collection modalities throughout the study’s lifecycle.”
The cloud-based Zelta platform for clinical trials offers a comprehensive solution for managing the complexities of clinical research. One of the standout features of Zelta EDC is its flexibility and security, making it highly effective for modern clinical trials, including DCT solutions. It supports studies across all phases and therapeutic areas, offering features such as eConsent, eCOA, real-time data validation, AI assistance for medical coding and study design, and customizable data management functionalities. This platform has been utilized in more than 4,000 studies worldwide, including an award-winning COVID-19 platform study that included over 30,000 global participants, thus showcasing real-world scalability and efficiency.
