In this talk I will give an overview of our main considerations for choosing and deploying digital health technology tools in GSK clinical trials. As an example, I will explain how we went about investigating the potential benefits digital biomarkers may bring to our assets and patients in two different disease areas: rheumatoid arthritis (RA) and amyotrophic lateral sclerosis (ALS).

From device deployment until data analysis, digital devices create a unique operational challenge for clinical trials. A single clinical trial may have 3 or 4 digital devices (such as a wearable device, an ePRO, and a smartphone), each from separate vendors with a separate cloud server that is not integrated with the chosen CRO. Operationally integrating these devices into a clinical trial requires specific in-depth knowledge of both the digital devices and the clinical operations workflow.  This presentation will discuss common challenges that arise within a clinical trial focused on validating a digital device in a specific patient population, and will recommend best practices for integrating multiple digital devices into a single trial.

This presentation will address several questions such as: -Digital Measures in life sciences – what are the use cases and value propositions? -What are the barriers for adoption and why is it so hard? -What have we learned about tech adoption over the past decades? -What could we do across the ecosystem to help accelerate adoption?

Pharmaceutical sponsors are leveraging many digital devices in study protocols to measure efficacy and real world data. However, patients don't adhere to these technologies and sponsors witness a lot of missing data. This presentation outlines approach to measure and manage the subject adherence.

This session will take a deep dive into maximizing the value of device data. Focusing on using the devices to generate digital endpoints, the potential to democratize clinical trials, create robust data for payers and support labelling claims.

The TransCelerate Digital Data Flow (DDF) Initiative's objective is to automate and optimize the configuration of clinical trial data capture and operational systems. Launched in 2018, DDF has outlined an approach to interoperability centered on a digitized protocol and a Common Data Model. In this session, TransCelerate members from Novartis, UCB, Amgen, Pfizer and Roche will share how the roadmap to enable end-to-end data flow has evolved from development of a Conceptual Design for a study builder to discussions about a common data model, interoperability and open architecture.

Under pressure to maintain patient safety and trial continuity during the pandemic, what had been a tentative, exploratory adoption curve for decentralized clinical trial (DCT) models quickly transitioned to the beginning of a new normal for patient-centric clinical trial conduct. Because DCT design doesn’t follow the traditional templates, some felt they were going back to the drawing board with each trial. For this reason, we’ve introduced a series of pre-packaged solutions 

Cmed Technology CTO, Dr. Tim Corbett-Clark shares his views on the current landscape within clinical trials, discussing the challenges that point and unified solutions bring. He also examines how to best optimize clinical trial data workflows by bringing the tech to data, removing the silos, and eliminating the barriers to getting holistic data for total control and visibility from phase one to four.

Overview of the Clinical Trial Solutions at Tempus which support precision patient identification and recruitment for oncology clinical trials through the TIME Trial program, a rapid activation Just-in-Time network of research-experienced clinical trial sites

Watch a live demonstration of protocol design utilizing real-world data on the TriNetX platform for a phase III cardiovascular randomized controlled trial, and a subsequent label expansion.

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.

To date, over a quarter of the studies in Medable's DCT portfolio include at least one connected device or wearable. Thus, we are pleased to share and discuss the best practices, case studies and approaches needed to optimally deploy Decentralized trial strategies globally. Join Alison Holland, as she uncovers the potential of sensors, wearables, and digital biomarkers under the guidance of decentralized trials.

Founded in 2006, Highthinkmed is the fastest growing clinical CRO in China with over 800 full time employees, providing one-stop clinical services including clinical operation, medical affairs, data management, biostatistics, pharmacovigilance, regulatory affairs etc. Highthinkmed owes its own eCTD system meeting requirements of FDA, EMA and NMPA with a professional team providing eCTD submission services. Highthinkmed welcomes all partners across the world for international collaboration.

Different endpoints derived from wearables can require very different wearable sensors.  Unfortunately, qualifying and integrating different wearables often from different vendors can be time-consuming and uncertain.  Learn how Shimmer Research is addressing this challenge by introducing a series of wearables that are all part of its highly flexible Verisense platform.