Test-Start-Scale is a methodology that takes digital innovation on a journey from idea through refinement, all the way to wider-scale use and BAU. The focus is on taking a data-driven approach which proves the value of the technology in a controlled fashion which can, in turn, help with promoting adoption leaving study teams satisfied and confident in new digital capabilities.

Digitising clinical protocol information can streamline system configuration during study start-up, enable analytics-assisted study design and feasibility, and support more routine use of point-of-care data for research. TransCelerate’s Digital Data Flow (DDF) initiative, in collaboration with CDISC, has delivered a foundational data model, exchange standard and open-source reference implementation aimed at supporting widespread use of digital protocols across industry. This presentation will highlight current DDF capabilities, demonstrated use cases, and a future roadmap for multi-stakeholder collaboration to achieve interoperability across research and care settings. 

An overview of high-fidelity synthetic data applications. Outline of talk: this presentation will provide an overview of synthetic data and applications of high-fidelity synthetic data, including the use of synthetic data for sample size boosting (data augmentation) and as synthetic control arms, in the context of clinical trials. The talk will reference related concepts like in silico trial approaches and digital twins, with concluding comments on regulatory considerations.

This talk will summarise the context for clinical trials research using routinely collected electronic health records (EHRs), including an overview of EHRs, commonly used databases, and data quality considerations. We will discuss advantages and limitations of using these data for clinical trials research with real-world examples.

Research with claims data and AI isn't just the future, it's the now. And the Health Data Lab (HDL) at the Federal Institute for Drugs and Medical Devices in Germany aims to make a significant improvement to healthcare by providing EHR data and claims data of all persons insured in statutory health care for research purposes. Sensitive health data will be processed in a secure processing environment to ensure the highest level of cybersecurity and privacy. In his talk, Dr. Steffen Hess will provide an overview of the HDL's capabilities and how AI will be implemented - for synthetic data as well as actual research.

StuffThatWorks (STW), rooted in WAZE's excellence, is a patient-focused RWE platform, scaling data collection. It harnesses crowd-sourced health data, mirroring WAZE's disruption in transportation, to remove treatment barriers and boost research. With consent from three million users across 1250 conditions STW is already the largest structured patient-level real-world evidence data set consisting of self-reported, geospatial, and recently added EMR data. Sponsors benefit from a SAAS-based dashboard enabling a broad range of, patient access and insight generation solutions.

As a world-recognized leader in research, Mass General Brigham is home to the largest hospital system-based research medical center in the U.S., supporting over 3,700 clinical trials at any given time. Drawing on our extensive research experience, we established the Hospital Integrated Research Organization (HIRO) to better empower industry sponsors, sites, and clinicians, and to accelerate AMC-based research globally. Our clinical research platform provides secure, IRB-approved access to comprehensive, multimodal, hospital-based data at each site, enabling us to run robust analytics to assess feasibility, inform study design, and improve patient recruitment. Our technology combined with our unique approach to collaborating with pharmaceutical and life sciences companies offers a brand-new way to engage with providers and deliver more effective research programs from the ultimate point of care.

The lack of attention to women’s health means that it has traditionally experienced less innovation compared to other therapeutic areas. More recently, as the digital health landscape rapidly evolves, there has been a concerted effort from several stakeholders to improve application to women’s health. This presentation delves into the latest advancements in real-world evidence, digital health technologies, and the application of AI in women's health, addressing current challenges and opportunities.

Technology is playing a greater role in clinical trials. This presentation explores the role of the AZ Solution Implementation Lead who: drives technology solutions implementation in the most patient- and site-centric way to drive simplicity and choice for patients; reduces patient burden from a technology perspective, utilising early design planning approach; and contributes to streamlined processes, improved data quality, and ultimately, successful trial outcomes.

I will delve into the evolving landscape of spirometry in clinical trials, emphasizing the shift towards decentralized trials and the implementation of remote-coached spirometry. Furthermore, I will explore the necessary adjustments for sponsors to stay ahead, addressing the associated risks and benefits while also highlighting the potential opportunities for improved patient engagement and data quality. I will also discuss the utilization of AI in spirometry, contributing to more efficient and accurate clinical trial outcomes.