Decentralized Trials & Research Alliance (DTRA) launched its first initiative to combat the lack of mutual understanding in the decentralised clinical trial (DCT) community. The DTRA Glossary aims to develop a common lexicon, making it widely available and fully transparent, says Craig Lipset, co-founder and co-chairman of DTRA. “If we don’t understand each other, it makes it harder for us to make progress and define key performance indicators,” he adds.
In Clinical Trials Arena we have commented previously on the risks of an ambiguous terminology not allowing the characterisation of DCT archetypes across the trial decentralisation continuum.
The glossary consists of nearly 100 terms and definitions, such as different roles in clinical trials, tools, outcomes, and documents. Still, this is a starting point, and the glossary will continue to grow and evolve over time, Lipset says.
He explains that the clinical trial community can share feedback with DTRA if any of the terms need further explanation or some definitions haven’t been added. “The suggestions will be reviewed on an ongoing basis to keep this glossary living and fresh,” he notes.
DCTs still in infancy
Indeed, DCTs are still in relatively early days and different stakeholders are progressing at slightly different levels. While decentralisation doesn’t have one clear and well-defined path, there is a common denominator that organisations use to align around in terms of a suite of different decentralised research methods. However, each stakeholder will have different needs based on the therapeutic area, geographies, and patient populations, Lipset explains.
Even the term DCT is a very inclusive term, representing a lot of different architypes, such as fully or partially decentralised trials. Sponsors should carefully engage with the study teams to avoid confusion of what the decentralisation actually means in that trial.
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“If their mind immediately gravitates to a very difficult archetype of a fully decentralised trial in their indication, that is going to put them off, set them defensive and make them very cautious,” he adds, noting that rallying around a common language will hopefully make it easier to work together.
New roles and sites to be defined
Yet, there is still ambiguous terminology, especially regarding sites and roles. Lipset shares that later in the year, DTRA will hold an annual meeting, and one session will discuss what a research site is in 2023. “We will bring out the voices that are looking into implementing mobile sites, retail pharmacies or visits taking place in local doctor’s offices,” he says.
Each of these new site models create new and different types of roles that haven’t been defined before. For example, there isn’t yet a term defining a provider in the community who is hosting a study visit but isn’t the traditional trial investigator.
Many of the research methods that are being deployed in DCTs, such as patient self-reporting or nurse home visits, have been available for some time. But now they are being used in a more purpose-driven way and bundling more than one together can add complexity to the protocol, Lipset says. Clinical Trials Arena has previously reported on most notable DCT trends and top therapy areas using a decentralisation approach.
More DTRA initiatives to come
With the first initiative launching last week, DTRA is just starting its work. When DTRA convened nearly two years ago, the members defined four priorities: definitions, best practices, education, and removing barriers. To delve deeper, 12 initiatives were identified as a blueprint of improving DCT implementation.
Some of them will map out global regulatory insights, deploy an educational curriculum for common baseline training of decentralised methods, and improve understanding of evidence generation. The latter is a growing and maturing field that the DCT community is still to become confident in, Lipset says.
He encourages the community to share and communicate their experiences to understand what is working and what’s not. As for the glossary, it has already received “vibrant discussions” around some terms on social media. Lipset says that it’s good and healthy for diverse stakeholders to share their feedback on the definitions only to grow more robust. “It’s really only meaningful if we’re embracing that language and starting to use those terms in a consistent way,” he notes.