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23 January 2023

Presenters: David Wright (AstraZeneca); Magnus Jörnten-Karlsson (Astra Zeneca); Magalie Hilton (roche); Yashoda Sharma (DiMe).

In a decentralised clinical trial, patients’ assessments are (partly) transferred from the clinical trial site to the patients’ home and might occur without any face to face interactions between patient and study personnel. In particular during the Covid-19 pandemic, decentralising clinical trials attracted considerable attention as one way to continue conducting trials during lockdowns and curfews. In this online event, experts in the field discuss the opportunities and challenges of decentralised clinical trials for the development of drugs and the promise they hold for modernising the way trials are conducted.

The presentations in part 1 of this meeting were as follows:  

What are Decentralised Trials? What are the key opportunities and risks with their use? (David Wright)
This talk gives an introduction to Decentralised Trials and outlines some of the opportunities and risks they bring if conducted instead of site based/centralized trials.  

Bringing true value to patients, site and sponsor through digital transformation of clinical trials. (Magnus Jörnten-Karlsson)
To successfully support decentralized clinical trials we need to think holistically about designing a toolkit for patients and sites. In this talk I will touch on how we define, evaluate and select technology (medical devices); current progress on the tools, moving away from isolated silo tools that only deliver one thing to broader platforms; and the impact that is having on our sites and patients.

ALpha-T: a Pre-Pandemic Decentralized Trial in Oncology.
(Magalie Hilton)
ALpha-T is a Phase II, Open-Label, Single Arm trial with a decentralized (DCT) home-based approach. Patients with locally-advanced or metastatic ALK-positive non-NSCLC are enrolled. The collaborations involving the patients, the caregivers, the sequencing partner, the telemedicine company, the regulators and the Sponsor are key for the implementation of home-based solutions. Based on this case study example, top challenges and opportunities of a DCT are presented.

Digital Medicine - Opportunities for Advancing Health Outcomes and Health Equity. (Yashoda Sharma)
Founded in 2019, the Digital Medicine Society (DiMe) is a global non-profit and the professional home for all members of the digital medicine community. Together, we drive scientific progress and broad acceptance of digital medicine to enhance public health. Digital medicine offers the potential to redefine healthcare, solving some of the most pressing and persistent challenges to good health for all. The digitization of healthcare presents a fleeting opportunity to move away from a system designed to treat the sick and toward one that is defined by each individual’s health. Core to our work of driving the development and adoption of digital health measurements is advancing health equity, to fuel the effectiveness of healthcare.
Challenges to effective and equitable clinical trials cannot be solved with individual entities working in isolation; multi-stakeholder, interdisciplinary expertise is required. DiMe partnered with the FDA and organizations across the healthcare continuum to prioritize inclusion in digital health measurement product development and deployment, and diversity, equity, and inclusion in digitized clinical trials. With this work we developed toolkits that healthcare and research organizations can incorporate into their current workflows to drive the adoption and implementation of digital and decentralized clinical trials, and best practices to ensure health resources are delivered with a health equity lens.


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