Global Coalition Develops Consistent Terminology To Support Decentralized Trials
Executive Summary
As regulatory agencies around the globe work on initiatives to support decentralized clinical trials, the Decentralized Trials & Research Alliance says a shared language is needed to facilitate the global adoption of such trials.
A global multistakeholder group that is working to promote the adoption of decentralized clinical trials (DCTs) has developed a glossary of common terms to improve the international adoption of decentralized research.
The glossary is expected to solve two major challenges relating to the uptake of DCTs, said the Decentralized Trials & Research Alliance (DTRA), the non-profit organization that published the online glossary on 29 August. These challenges relate to the lack of consistent terminology for use within and between organizations, and a lack of a lexicon to describe different archetypes of decentralized research.
Decentralized trials have drawn huge interest since restrictions related to the COVID-19 pandemic started making in-person clinical research visits difficult, if not impossible. Regulatory authorities around the globe are keen to support DCTs as they can make research faster and more efficient by allowing all or most trial activities to be conducted remotely, in or near a patient’s home.
Regulators Are Taking Step To Support DCTs
-
Plans Press On To Harmonize Decentralized Clinical Trial Requirements In EU
-
Clinical Research Needs To Move ‘Out Of The Ivory Tower,’ FDA’s Woodcock Urges
-
Switzerland Supports ‘Increasingly Important’ Decentralized Clinical Trials
-
Canada Seeks To Make Decentralized Trials More Practical For Sponsors
Regulators in the EU, the US, Switzerland and Canada have announced initiatives to this end. (See sidebar)
Against this backdrop, the DTRA emphasized the need for a “shared language” to facilitate the global adoption of DCTs. Craig Lipset, co-founder and co-chairman of the alliance, said it was “impossible to make progress when there is a Tower of Babel and we are not able to understand one another.”
The glossary addresses the issue by establishing common definitions of key terms used in the context of decentralized research. For example, it clarifies that “home health care” can encompass a “wide range of health care services that are given to a patient in their home” for which a variety of providers may be involved, including but not limited to home health nurses, phlebotomists, doctors, among others.
The glossary, which can be accessed via www.dtra.org/1a-glossary, “marks an important milestone in enabling understanding and uptake of methodologies that will improve access to research for patients,” said DTRA co-chairman and co-founder Amir Kalali. It includes an interactive feedback collection tool to receive updates on existing terms while also identifying potential new terms.
Developing a glossary was among 12 initiatives that DTRA announced last year, when it outlined its priorities. Other initiatives in the pipeline are centered around identifying and promoting best practices in decentralized research, building a knowledge repository and mechanisms for information sharing, and identifying barriers to decentralized research implementation and establishing roadmaps for their resolution. (Also see "Global CRO Body Addresses Data Integrity In Decentralized Trials" - Pink Sheet, 30 Jul, 2021.)
The DTRA, which was established in December 2020, comprises 125 members, including the US Food and Drug Administration, drug companies, several contract research organizations, patient advocacy groups and other members of the research community. Its aim is to make research participation accessible to everyone, enabled by the consistent, widespread adoption of appropriate decentralized research methods. (Also see "New Global Alliance To Drive Momentum On Decentralized Trials" - Pink Sheet, 11 Dec, 2020.)