Priority 1: Definitions
Establishing common nomenclature & definitions around the practice of decentralized research to Understand, Plan, and Execute Decentralized Studies Faster and More Effectively.
The Goal
Our goal is to establish a common vocabulary through a comprehensive glossary, define clear benchmarks with key performance indicators, and create a DCT Change Management Framework. These initiatives aim to foster a more efficient and collaborative environment for decentralized clinical trials by addressing communication, productivity, and adoption challenges.
DTRA Glossary
Our comprehensive Decentralized Research Glossary aims to build a common vocabulary and shared understanding among stakeholders, making communication clearer for everyone involved. A feedback form has been integrated into the glossary so that the glossary becomes a live toolkit, based on suggestions for new and existing terms from end users.
Jared Klingeisen,
Initiative Team Co-Lead, previously with Medable, currently at RsLightning.
“A common vocabulary and shared understanding are critical to clear alignment and improving efficiency. We hope that this glossary can be used by any organization to leverage when communicating with other companies within this space, as well as make things as clear as possible for sites and patients to understand.”
Key Performance Indicators
Our team consolidated ten benchmark metrics that encompass input from patients, sites, service companies, and sponsors. The goal of these KPIs is to help DCT project teams measure the impact of the methods in studies (e.g., recruitment speed, diversity, quality, and protocol compliance). These key performance indicators (KPIs) follow the standard language from the glossary and have been provided to the DTRA Member Community for testing in their respective organizations.
Anna Yang,
Initiative Team Project Manager, Genentech, a member of Roche Group
“Team 1B operates with intense speed and creativity, which allows us to lean into ambiguity. We quickly developed an inspiring purpose statement, roadmap, and governance. We achieved our deliverables ahead of time and are looking to exceed scope by producing not just a KPIs list, but the definition and calculation of metrics.”
Changing the Norm
As part of our efforts to advance DCTs, we have been working on creating a DCT Change Management Framework in consideration of change management best practices for stakeholders around the world. Our team has identified organizational barriers and is developing this framework to address them. The framework, currently in its final stages of review, focuses on key barriers to adoption.
Laurie Halloran,
Co-Lead, Halloran Consulting
“We are excited to have a well-designed survey to collect input on what the barriers are to adoption. We have sent it out to hundreds of candidates to collect information so that we are ‘changing the norm’ with valid information on what the challenges are.”