The future of clinical trials is adaptive: Insights from our latest white paper

The highly anticipated white paper exploring Adaptive Platform Trial (APT) designs has been officially launched and is now available for download. This pivotal document provides a comprehensive overview of the APT landscape. It explores the advantages and potential of APT design in addressing the challenges of traditional clinical research and the pivotal role of organisations like Ecraid in advancing this innovative methodology to improve patient care.

Traditional clinical trials, often characterised by their fixed designs, can be slow, resource-lacking, and less adaptable to emerging data. The COVID-19 pandemic starkly highlighted these limitations, underscoring the urgent need for more agile research methodologies. 

This is where APTs step in as a game-changer.

Alongside this innovation in trial design, an integrated and collaborative warm-base clinical trial network provides a sustainable and efficient approach. This foundation of investigator networks, governance, regulatory structure, and data management systems build a culture of collaboration, discovery, and continuous improvement. 

APTs represent a revolutionary shift from the conventional "one drug, one trial" model. In an APT, multiple interventions for a single disease or condition are evaluated simultaneously and continuously within a single, overarching trial structure. Common features of APTs include:

• Master protocol: APTs use a single overarching protocol designed to evaluate and answer multiple hypotheses and to study multiple targeted therapies in the context of a single disease perpetually. The total protocol is usually modular, to facilitate the inherent adaptations and it prospectively defines the criteria's for adding and closing different treatment arms as the trial progresses.   
• Perpetual: Treatments can enter or leave the platform based on predefined decision algorithms, allowing for continuous enrollment, learning, and adaptation. 
• Adaptive elements: The trial design can be modified in real-time based on accumulating data. This includes (but is not limited to) adapting sample size, adjusting randomisation ratios, dropping less effective arms, or adding promising new interventions. 
• Bayesian statistical methods: APTs often leverage Bayesian statistics, which are well-suited for iterative updating and adaptation, enabling more informed decision-making throughout the trial.
• Focus on the disease, not the interventions: The design centres around the disease or condition itself, allowing for a more comprehensive and evolving understanding of optimal treatment strategies across different patient groups. 

Ecraid has embraced APTs embedded in a warm-base network as a core strategy to overcome the fragmentation and inefficiencies that have historically plagued infectious disease research. Building on the foundations of projects like REMAP-CAP and ECRAID-Prime, Ecraid's experience demonstrates the tangible benefits of this approach.

This white paper on APT design emphasises how Ecraid is leveraging this methodology to:

• Accelerate Research: By testing multiple interventions concurrently and adapting in real-time, APTs can significantly reduce the time required to identify effective treatments.
• Enhance Efficiency: Shared infrastructure, a common control arm, and the ability to drop futile interventions minimise wasted resources and patient exposure to ineffective therapies.
• Improve Pandemic Preparedness: The warm-base network, the foundation of Ecraid's operations, enables rapid activation and deployment of APTs in response to emerging infectious disease threats. This preparedness ensures that Europe can respond swiftly and scientifically to future outbreaks.
• Generate Robust Evidence: The flexible nature of APTs, coupled with rigorous statistical methods, allows for the generation of high-quality evidence to inform clinical practice and public health policies.
• Foster Collaboration: Ecraid's model promotes collaboration among academic centers, healthcare providers, and industry partners across Europe, creating a unified front against infectious diseases.

Through initiatives like our training modules on adaptive clinical trial designs and ongoing projects such as ECRAID-Prime (an adaptive platform trial for COVID-19 therapeutics in primary care), Ecraid is actively demonstrating and promoting the practical application of APTs. 

Adaptive platform trials, embedded in warm-base clinical trial networks, such as Ecraid, are the future of clinical research and the building blocks to more efficient, ethical, and impactful research and healthcare.

By championing adaptive platform trial designs, Ecraid is not just conducting research; we are actively shaping the future of clinical trials, ensuring a more responsive, efficient, and ultimately more effective approach to combating the ongoing challenge of infectious diseases.