Decentralized Clinical Trials (Challenges & Opportunities)
Chair: Herb Pang (Genentech)
Vice Chair: Rakhi Kilaru (PPD, part of Thermo Fisher Scientific)
Speaker: Leonard Sacks (FDA)
Title: Decentralized clinical trials; mapping the road to patient convenience and inclusivity
Abstract: Participation in traditional site-based trials is challenging for big swathes of the patient community. Many of the challenges to participation can be addressed with a bundle of practical strategies allowing some or all trial-related activities to take place at patient homes or nearby locations. As we move into an era of telemedicine and decentralized healthcare, many of the tools for decentralized trials are available to us. This talk will review the limited experience we have had with decentralized trials, and will examine the opportunities and challenges associated with remote trial visits, supervision of decentralized trial activities, use of digital health technologies, direct distribution of investigational product to patients and other innovative approaches to bring the trial to the patient.
Speaker: Khadija Rantell (MHRA, UK)
Title: Building resilience into clinical trials: opportunities and challenges of decentralized approaches in clinical trials
Abstract: The shift toward patient-centricity means that trials need to be built around the needs of trial participants. Decentralized clinical trial (DCT) models have been years in the making but their adoption was only recently boosted by the COVID-19 pandemic.
Integration of DCT elements into studies has been enabled by the proliferation of new digital technologies for data collection and trial conduct. This talk will cover key considerations for suitability of use of decentralised clinical trial model, reflecting on the opportunities and challenges of implementing decentralised elements in clinical trials from a regulatory perspective.
Speaker: Petra LeBeau (PPD, part of Thermo Fisher Scientific)
Title: Statistical and operational considerations in decentralized clinical trials
Abstract: Digital technology has been advancing rapidly worldwide, more so than any innovation in history. In the past few years, clinical research has experienced a heightened need and openness for digital innovation and has been pushed to adopt some of the technologies available. Sponsors have been searching out strategies to remotely engage with patients to ease their burden of participation in clinical trials as well as to ensure trial continuity when unexpected situations arise.
DCTs are leveraged to speed up recruitment, cut trial timelines and costs, improve patient retention rates, increase convenience and comfort for the patient, and reach more diverse populations, expanding geographies and removing barriers. Digital health technology such as continuous assessment through wearable sensors, electronic daily diaries, and sensor based out-of-clinic tasks generate large amounts of data. This requires infrastructure technology with an ability to ingest, pre-process, integrate and store this data as well as statistical analyses that go beyond the traditional methods, focusing on key aspects of the data in order to handle the volume of data collected.
In this talk, we will share our experiences from planning for inclusion of digital health technology into our clinical trial platform processes. We will address technological and operational frameworks as well as statistical methodologies to address the data challenges, and why it is critical for diverse stakeholders and thought leaders to come together to collaborate on the best path forward.
Discussant: Hans Ulrich Burger (Roche)
