Decentralized Trials and Research Alliance Unveils DCT Glossary
In an effort to foster greater adoption of decentralized trial (DCT) methodologies, the Decentralized Trials and Research Alliance (DTRA) has published an online glossary of clinical research and DCT terms.
The glossary, developed collaboratively across industry, aims to deliver more consistent clinical trial terminology and descriptions of different DCT elements, according to the DTRA, a nonprofit organization formed to spur discussions and cooperation between stakeholders on patient-focused decentralized trials.
For instance, there’s been much discussion within the industry about what exactly a DCT itself is as decentralized approaches become increasingly used; the glossary defines it as “a clinical trial utilizing technology, processes, and/or services that create the opportunity to reduce or eliminate the need for participants to physically visit a traditional research site.”
The term “hybrid trial” has also been discussed and has been used to describe those trials that employ a mix of on-site and decentralized components, rather than fully remote trials (which may be defined as DCTs). This is listed in the glossary as describing “a suitably flexible scenario that partially eliminates the requirements for participants to visit a physical trial site to perform a protocol-required event that may have traditionally taken place on-site.”
The glossary notes two archetypes for hybrid trials: hybrid by site, in which “some participants participate at a traditional research site while others engage entirely via decentralized research methods,” and hybrid by visit, “where some visits in the protocol require the participant to be seen at a traditional research site, while other study visits can be conducted using decentralized research methods.”
The glossary is not static and may receive updates via an interactive feedback-gathering tool for modifying existing terms and adding new ones.
Access the glossary here: https://bit.ly/3qELZdS.