Do decentralized trials still offer clinical precision in challenging patient populations?

Irrespective of modality, all clinical trials rely on accurate measures of efficacy and safety. When performing assessments remotely in challenging populations (e.g., Alzheimer’s), what considerations for assessing and ensuring measurement precision must be made? What are the implications on the role and responsibility of the site when dealing with challenging populations? And how can effective patient oversight and data quality monitoring be assured?

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https://www.pharmexec.com/pe_w/decentralized

Event Overview:

Effective decentralized clinical trials go beyond the application of enabling technology, such as telemedicine. Irrespective of modality, all clinical trials rely on accurate measures of efficacy and safety. When performing assessments remotely in challenging populations, what considerations for assessing and ensuring measurement precision must be made?

In this webinar, an example of an Alzheimer’s disease trial migrated from in-clinic to remote study during the COVID-19 pandemic is discussed, as well as how a patient-empathetic approach was used to overcome issues associated with technology literacy and how measurement equivalence with face-to-face assessment could be assured when using the common assessment scales such as the ADAS-Cog and the MMSE.

As guidance from the regulatory agencies on decentralized trials evolves, what are the implications on the role and responsibility of the site when dealing with challenging populations? And how can effective patient oversight and data quality monitoring be assured?

Key Learning Objectives:

• For participants – what issues need to be considered to produce robust and meaningful data? How do we implement assessments intended for in-clinic administration in remote settings, while ensuring their accuracy and precision?
• For sites – what new responsibilities might sites have under GCP and regulatory guidance when the home becomes an extension of the clinical research site? How do we enable effective patient oversight with increasing remote assessment? How do we lower operational burden and provide one unified environment for a single source of truth for patient data to empower investigator oversight?
• For sponsors/CROs – how do we diversify trial participation and enrich data insights by leveraging decentralized elements, while also applying powerful analytics that ultimately lower the total cost of ownership?

Speakers:

DAVID MILLER, MD, MA
Clinical VP
Signant Health

Dr. Miller is a Geriatric Psychiatrist by training. He has over 25 years of experience in patient care, clinical research, and teaching. Dr. Miller is a Clinical Vice President at Signant Health (formerly Bracket), responsible for Dementia and Geriatric Psychiatry. He is the Immediate Past-Chair of the Alzheimer’s Association Research Roundtable, the Co-Chair of the ISCTM (International Society for CNS Clinical Trials and Methodology) BPSD Work Group and was the founding Co-Chair of the ISTAART funded Neuropsychiatric Symptoms Professional Interest Area (NPS-PIA). Dr. Miller has served as a principal investigator for dementia clinical trials and has been the expert presenter for over 100 dementia-related clinical trials. Dr. Miller publishes and presents locally, nationally, and internationally on his dementia-related research.

JAN BREEMANS
Sr. Director Analytics
Signant Health

Jan Breemans is advising Signant Health and its customers on the value and use of data analytics in the oversight of their clinical development programs. Prior to joining Signant Health, Jan worked on the sponsor side for over 20 years and gained substantial experience in the fields of data management and analytics, project management, and clinical systems management. Jan has a Master’s degree in Biochemistry and a post-graduate qualification in Relation & Communication Management.

GILLIAN WORMAN
Director, Product Strategy
Oracle

A life science professional with over 25 years’ experience in the pharmaceutical industry, Gillian works as a Product Strategist within Oracle’s Health and AI team, focusing on clinical trial planning, management, and monitoring.

Before joining Oracle in 2016, she held a broad range of clinical operations and systems implementation roles in pharma and biotech organizations, including CRA, project manager, and business application manager, supporting utilization of systems in development of operational excellence.

DAVID BLACKMAN
Executive Director, Digital Trials Strategy
Oracle

David Blackman has responsibility for aligning digital strategies and innovations with Oracle’s developing business needs. David is responsible for creating and developing differentiating technology and business capabilities through development, partnerships, and acquisitions that enhance clinical trial research and accelerate bringing drugs to market.

Before joining Oracle in 2021, he served in the Corporate Development and Strategy group at PPD, where he held responsibility for PPDs business innovation, leading and incubated cutting-edge business solutions resulting in the investment, development, integration, and commercialization of digital and remote clinical trials capabilities. Prior to that, David worked at IBM/Lenovo, where he held several global technology and business leadership roles.

A graduate of the University of Johannesburg in South Africa, he combines his more than 20 years of technological experience in development, process, and technology innovations with his commitment to implementing cutting-edge technologies as a platform that advance innovative technology solutions in clinical trials worldwide. He holds two patents for technology in human factors innovation.

Register Free:

https://www.pharmexec.com/pe_w/decentralized