The Next Generation of Vaccine Mega Trials

Vaccine mega trials are being transformed by advances in artificial intelligence, patient-centric trial designs, global collaboration and more. Are you ready for what the future holds?

In the realm of vaccine development, mega trials — studies enrolling 5,000 subjects or more — have been instrumental in the fight against many pathogens, including influenza, rotavirus, malaria, RSV and most recently in the rapid development of vaccines against COVID-19. The landscape of these trials is evolving, influenced by technological advancements, changing industry standards and innovative clinical trial designs. Explore the unique aspects of mega trials, the challenges they pose to vaccine developers, what the future holds for these large, complex trials, and how a partnership with an experienced provider of clinical research solutions can enable success.

Vaccine clinical trial trends

Several emerging trends are shaping the vaccine mega trials of tomorrow — and the common theme linking each is the desire to drive efficiency. As the landscape evolves, technology will be a significant force behind many of these efforts and will factor heavily into the future of mega trials.

• Big data: The role of big data and real-world data (RWD) will continue to expand, providing deeper insights into patient behaviors, disease patterns and treatment effectiveness in real-world settings.
• Decentralized trials: Trials that effectively leverage digital technologies — enabling data collection outside traditional clinical settings and enhancing patient accessibility and participation — will have an advantage in the race to develop new vaccines.
• Patient-centric trials: Trial designs that prioritize patient convenience will be better positioned to gain efficiencies through improved participant recruitment, retention and compliance rates.
• Wearables: Wearable devices, combined with AI, are transforming clinical trials by enabling remote collection of pertinent medical data. These cutting-edge tools offer promising prospects for monitoring physiological responses to vaccines as well as incident disease events.
• Global collaboration: The power of collective efforts in vaccine development — demonstrated during the COVID-19 pandemic — is likely to continue, as the world witnessed firsthand the importance of coming together to address common threats.

Driving efficiency: Harnessing artificial intelligence (AI)

Successful deployment of artificial intelligence (AI) has accelerated vaccine development, most notably in the race to develop COVID-19 vaccines. As the vaccine development landscape evolves, AI will continue to play a transformative role in streamlining various aspects of these mega trials, from predictive modeling to patient recruitment and data analysis.

The need to explore advanced modalities and ways to drive efficiencies to accelerate vaccine development in response COVID-19 and in anticipation of future global health crises has underscored the need for new approaches to trial design and execution that can achieve these objectives. Ways in which AI can aid in designing and executing trials include:

• Optimize study design and protocol development, including the identification of potential efficiency measures to reduce overall trial length, sample size or the number of study arms needed
• Simulation of the immune system and creation of predictive models to identify novel targets for vaccines, revolutionizing the pace of vaccine development
• Efficient management of the massive volumes of data generated in vaccine mega trials, leading to quicker and more accurate evaluation of vaccine safety and efficacy
• Enhanced patient recruitment, making the process more efficient and effective

Addressing industry concerns: Diversity and inclusion and study acceleration

Diversity and inclusion in clinical trials are critical to ensuring the development of vaccines that are effective across different populations, thereby promoting health equity. Owing to their sheer size, mega trials have greater potential to achieve the necessary inclusion of historically under-represented patient groups and communities through targeted outreach and recruiting efforts designed to support diversity and inclusion goals. Large-scale global studies stand to benefit from the use of technologies such as AI and patient-centric study designs that incorporate decentralized elements to improve trial efficiency and effectiveness, reduce cost and reduce participation barriers to improve patient recruitment.

Unique aspects and challenges of vaccine mega trials

Due to their large scale and complexity, vaccine mega trials present unique challenges. Selecting an experienced provider of clinical research solutions, with the end-to-end services, real-world experience and deep expertise in vaccine development, endpoint collection and adjudication is vitally important to effectively and efficiently manage the unique challenges these studies pose.

1. Regulatory compliance: Navigating and complying with a variety of regulatory requirements, which may vary across different countries, can be complex.
2. Coordination and communication: Coordinating the various components of a mega trial requires effective communication and management.
3. Data management: Ensuring the accuracy and integrity of the enormous volumes of data generated in a mega trial is critical.
4. Recruitment and retention: Recruiting a large and diverse pool of participants and retaining them for the duration of the trial can be a challenge.
5. Ethical considerations: Ensuring the ethical conduct of a mega trial, including obtaining informed consent from thousands of participants and ensuring equitable access to the trial, can also be a logistical challenge.
6. Laboratory services: Securing access to vaccine-specific laboratories with sufficient capacity, automated assays and the specialized expertise necessary to support the significant analytical demands generated by mega trials is an important consideration.
7. Distribution and storage: Transporting and storing vaccines often requires precision cold-chain handling and specialized services. Managing these logistics can be particularly challenging in a mega trial spanning multiple countries.

What the future holds

The future of vaccine mega trials is set to be shaped by technological advancements, innovative clinical trial designs and evolving industry standards. Despite the unique aspects and challenges they pose, these trials, with their ability to provide robust evidence about the safety and efficacy of vaccines, will continue to play a crucial role in advancing global health. The collective impact of these trends will create a favorable future that is likely to witness an increase in the use of vaccine mega trials to address preventable diseases on a diverse and global scale.

When deep vaccine expertise and global scale matters most

Successful planning and execution of vaccine mega trials requires specialized expertise and experience combined with integrated capabilities and global reach. With over 30 years of vaccine development experience, the PPD™ clinical research business of Thermo Fisher Scientific offers a comprehensive range of integrated services for successful planning and execution of vaccine mega trials. Over the past five years, we have conducted 10 global-scale vaccine studies with more than 5,000 subjects targeting endemic and pandemic diseases, such as tuberculosis, influenza, cytomegalovirus, dengue fever and COVID-19.

Our end-to-end capabilities include more than 90,000 square feet of dedicated vaccine laboratory space with automated platforms ideal for high-volume studies, priority vaccines site network, patient enrollment solutions, integrated data technology, and digital and decentralized solutions. Our dedicated team of experts collaborates to optimize vaccine trials, ensuring top-quality studies that prioritize patient needs. We empower our vaccine experts to embrace innovative approaches and technologies, delivering efficient, cost-effective and patient-centric studies.