Novel digital endpoint, if used as the prespecified ranked endpoint in the registrational studies, may enhance labels and enable market access. Many pharmaceuticals are developing novel digital measures of health and disease to accelerate drug development and support product differentiation.

Digital health technologies (DHT) are transforming how we develop new therapies and assess their impact on patients. The shift was accelerated by the COVID-19 pandemic as clinical teams have rushed to enable decentralized trials and improve patient monitoring. While the industry still faces significant obstacles in validation of novel digital endpoints (NDE) we are working toward a new methodological framework to validate wearable sensors and advanced analytics.

This presentation will share case studies of leveraging digital biomarkers for internal decisions as well as for modernizing endpoints.

Exploring the power of combining enhanced evidence, mobile technology and connected devices in Healthcare and Research. 

Diagnostic devices and wearables have become commonplace and their presence is increasing within clinical trials. In addition to providing novel collection of data these solutions must meet quality and regulatory standards. eSource technology provides sites and patients with the opportunity to collect quality data. This presentation will provide an overview of why eSource technology is the key to scalable and compliant devices and sensors being employed now and in the future.

Digital measures enabled by wearables offer a patient-centric approach to assess real-world behaviors of clinical trial participants. Objective insights into how people function in their natural environment help us better understand meaningful aspects of treatment effect. Several recent cases have demonstrated the ability of digital endpoints to assist clinical decisions/development. This presentation discusses the framework for deploying and validating digital endpoints and the path from digital data to clinical insights.

In this case study, PPD will illustrate how the amalgamation of a DCT platform, remote patient monitoring, wearables, sensor devices, and rapid response home healthcare services contributed to the success of a clinical trial conducted during the COVID-19 pandemic. We will highlight the thoughtful design and data and systems architecture allowed the trial to be more patient-centric while simultaneously providing high quality, real-time data to ensure stronger health outcomes.

There are different regulatory pathways available for digital endpoint development teams to get health authority advice on the validation of novel digital measures and their acceptability as label enabling endpoint in pivotal clinical trials. This presentation will cover examples of digital endpoint developments that used different regulatory pathways, their challenges and opportunities and considerations for regulatory strategies.

Sponsors and CROs need more than change management to operationalize decentralized trials. In this session, Kyle Hogan will outline the approaches sponsors and CROs can take to build value in the decentralized trial participant journey, from pre-implementation to study launch and monitoring. 

Delays in clinical trial patient enrollment are significant challenges for sponsors, especially for biomarker-targeted investigational therapies associated with rare genomic variants. Join us and discover the solutions offered by SOPHiA GENETICS, leveraging insights from multimodal datasets - including 770’000 genomic profiles - curated across 780+ healthcare institutions. We can better enable biomarker-driven clinical trials in oncology and inherited rare disorders to meet recruitment goals by identifying potential sites worldwide.

Within a pharma company, developing a digital visit testing site using internal volunteers to test electronic devices and digital platforms will enable more successful usage of these technologies in clinical trials. The goal of the digital visit is to proactively address basic usability issues, “test-drive” the proposed visit protocol, and identify necessary training mechanisms/materials. This presentation will discuss Takeda’s efforts to create a lightweight and agile digital visit testing site within R&D.

The push to decentralize healthcare is touching every part of the patient journey, from how patients engage in research to how they receive clinical care. Today, sensors and wearable technology can provide a window into the home, improving patient engagement as well as the ability to measure outcomes and prove efficacy. However, data insights are only as powerful as the data collected. Knowing what data to capture, which devices to use, and how to effectively engage patients is critical to your ability to unlock the benefits of real-time, real-world data. Pulling from our experience working with leading health systems and global pharmaceutical companies, we’ll explore the ways we’ve helped them leverage the power of patient data in the home to generate rich insights, improve patient experience and create value.

Neuro clinical trials become the breaking ground for implementation and adoption of digital measurements. This presentation will share recent advantages and case studies of digital biomarkers in several CNS and trials.