Three Key Critical Considerations Before Embarking on Decentralized Trials

Katherine Vandebelt
Global Head of Clinical Innovation

Many organizations conduct trials in the traditional manner using investigator sites, in-person monitoring, and face-to-face engagement, while new approaches have emerged, leveraging technology that has enabled virtual visits and remote patient monitoring. This new innovation has provided new ways to gather critical patient information and create efficiencies which has forged the path for hybrid and decentralized clinical trials.  

These rapidly expanding approaches do not benefit the sponsor alone. Studies are more accessible and convenient improving patient experience, while investigators gain valuable patient insights. Expedited processes help sponsors get answers to their scientific questions faster. 

It’s not enough to choose a patient-facing technology, the entire data flow needs to be optimized. Consider the effect on data quality, healthcare professional workflow, patient ability to comply, and feasibility of conducting a trial across geographies. 

However, moving in this direction requires change. Trying to incorporate new world innovations into a traditional protocol design and operational practices doesn’t fit. Barriers that lie within technology infrastructure, personnel, and even the classic ‘status quo’ have also perpetuated this lack of migration. 

The hesitancy to change is understandable given the potential impact on an organization. Are decentralized and hybrid trials right for your organization? A deep understanding of what constitutes a hybrid or decentralized clinical trial is necessary in order to effectively determine if a shift is the right move.   

Please join us for this webcast - "Three Key Critical Considerations Before Embarking on Decentralized Trials":

Live: Tuesday, January 28, 2020

11am EST | 10am CST | 8am PST

On Demand: available after airing until January 28, 2021

Hosted and moderated by Elaine Quilici, Senior Editor of Pharmaceutical Executive. I will be joined by Taras Carpiac, Executive Director, Innovation and Process Improvement at Amgen, to delve into and understand what constitutes hybrid and decentralized clinical trials, what does a protocol look like for hybrid and decentralized trials, and what are the ways to optimize new clinical trial technologies. 

This webcast is the first in a three-part series focusing on the journey organizations must take to move towards decentralized trials, or hybrid trials. The series will explore this new realm of virtual and tackle questions such as ‘why’ the change is necessary, and ‘how’ to change. Each webcast will provide clear instruction on how to move towards a virtual ecosystem that is right for your organization. The second webcast will be held in March, and the third will be in May.

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