By Allison Proffitt 

September 8, 2022 | Last week the Decentralized Trials & Research Alliance (DTRA) announced the release of the DTRA Glossary, an interactive lexicon to provide a consistent vocabulary for decentralized research and improve the global adoption of decentralized research. The DTRA Glossary is accessible to the global research community and all relevant stakeholders at www.dtra.org. 

A common language is critical to DTRA’s mission to ease global adoption of decentralized research, contend DTRA Co-Founders Dr. Amir Kalali and Craig Lipset. “Most all stakeholders in research are in some stage of evolution in adopting these new approaches, whether hybrid or fully-decentralized approaches.  This common language will also be foundational as DTRA continues to release other tools and resources from member-driven initiatives addressing further challenges in adoption,” the two explained in email correspondence with Clinical Research News.  

Decentralized trials have suffered from language that is unclear and inconsistent, they observe. “As an industry we tend to speak quickly in jargon and acronyms,” the two said. “At the same time, we operate in a highly matrixed field and must regularly communicate between sponsors, CROs, investigators and site staff, global regulators, IRBs/ethics committees and patients.”  

Jargon can be a stumbling block for teams, slowing down progress and hindering trust-building that is so important in a project, they said. Unfamiliar language can also make groups hesitant to try new approaches. “When teams misinterpret what is being proposed for a study, it may be viewed as having greater risk or less impact and could be dismissed despite offering a meaningful way to improve conduct,” they added.  

And since jargon is ubiquitous in clinical research, DTRA hopes that coming to a consensus on these terms will dramatically smooth the clinical research process.  

The first version of the glossary includes more than 80 entries defining such terms as clinical team manager, data sharing, data clarification form, eCOA, ePRO, hybrid trial, interoperability, investigator site file, medical monitor, protected health information, redact, serious adverse events, and more. The glossary was built by a team comprising, “a diverse cross section of leaders representing many different stakeholders involved in the clinical research,” Kalali and Lipset explained.  

“Their process was designed to begin as highly inclusive, encouraging sharing a wide range of possible terms no matter if similar or even redundant,” the two said. “The process then moved from expansive into a contraction stage, merging similar jargon under a single definition. Critical to the process has been the inclusion of individuals representing diverse stakeholders to dissect, challenge, and pressure test each term.”   

The first version of the glossary—labeled 1A on the DTRA site—includes an interactive feedback collection tool to receive updates on existing terms while also identifying potential new terms. “The Glossary must be a living document to keep up with that change,” Kalali and Lipset said.  

“Feedback from the research community will be critical, as the strength of the Glossary over time will depend upon the number of eyes set on it. If stakeholders are using a term differently, or something is missing, we need to know to be dynamic and adaptive with regular reviews and revisions. In the last 3 years research has changed completely, and that revolution is going to continue.”  

The two also highlight that the feedback process itself is a marker of the success of the tool. “We are already seeing the research community strengthened through healthy discussion around missing terms and definitions that may be further enhanced,” they added.  

The entries are currently tagged, grouping them into five categories: foundation terms, tools, stakeholder nomenclature, forms, and outcomes terms. Kalali and Lipset expect these tags to help users search and filter the glossary, particularly as it grows, and acknowledge that the tags may also change with time.  

The DTRA Glossary is the first output from DTRA’s 12 initiatives spanning four priorities as developed by the DTRA Leadership Council. The Glossary Team was co-led by Jared Klingeisen and Alison Poole with program management by Alexa Christensen.  

DTRA members are not required to use the glossary, or the definitions contained within, but Kalali and Lipset are confident that the tool will facilitate decentralized clinical research in an important way. “We believe there will be sufficient value in the research community embracing common jargon that DTRA members and non-members will be more efficient in using the Glossary,” they said. “Members and individuals are free to adopt at their own pace, but over time we believe the value proposition will be the driver of adoption.”