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THREADDCTs

Combining Patient-Centric Technology and RWD for Comprehensive Evidence

Dallas Miles

Digital Technologies & Decentralized Research

Digital technologies that have primarily been used to decentralize clinical trials can be used to optimize the capture and curation of certain types of real world data (RWD) from patients. By combining these digital technologies with secondary RWD, researchers can gather a more holistic understanding of the patient.

The term “digital technology” encompasses a broad suite of potential technologies. Digital technologies typically used to run decentralized clinical trials (DCT) focus on facilitating data capture outside of a research site using tools like tele-health, notifications, wearables, eConsent, eCOA, eSource, eDiary, sensors, and eDROs. Use of these technologies in clinical research has proliferated over the past few years as research sponsors have looked to implement more resilient and patient centric clinical studies.

What is Real World Data (RWD)?

RWD are data relating to patient health status and the delivery of healthcare. These data are routinely collected from a variety of sources and, when captured and analyzed appropriately, can be used by clinical researchers as clinical evidence describing the usage and potential benefits or risks of a medical product. Digital technologies can play a valuable role in the generation of real world evidence (RWE) as these technologies can optimize the capture of RWD from patients (patient-generated RWD) while also enabling the consent and identity management processes that are commonly needed to access secondary data (such as those from electronic health records, medical claims and billing data, etc.). By using a decentralized clinical trial technology infrastructure in an RWE program, the full patient experience is facilitated by a mobile or web-based application allowing researchers to collect all of their patient-generated RWD directly via the study application and then researchers can use that same application for collecting informed consent and tokenization that facilitates access and linkage to secondary data - the result is a more comprehensive data set on each research participant.

Simplifying the Patient Experience

One example of where THREAD is applying this thinking today is in a post-authorization study for a rare disease therapy. THREAD’s platform is the primary data capture solution for all primary RWD generation with tele-health, eConsent, eCOA deployed through a single mobile application interface, and then THREAD’s platform links to EHR data aggregated from research sites participating in the hybrid decentralized study. One of the results is a significant reduction in research site burden around data entry.

To learn more about how to implement a digital strategy to optimize RWE programs, check out this recent webinar from Reuters, hosted by THREAD’s Executive Director and Head of Strategy & Partnerships, Joss Warren, and Eversana’s President of Data & Analytics, Brigham Hyde, Ph.D. Click here for access to the full webinar now.

Joss Warren

Executive Director, Head of Strategy and Partnerships, THREAD

Joss is a focused leader and thoughtful innovator with a passion for solving difficult problems. Over the last decade, Joss has been dedicated to innovation in clinical research with experience that includes application of real-world data to optimize clinical trial planning, construction and design of external control arms, and use of technology to enable decentralized clinical trials. As the Director of Partnerships at THREAD, Joss works with leading companies to develop collaborative solutions that integrate with THREAD’s decentralized clinical trial platform to create new value for researchers, patients, and sites.