What universal alignment of industry terminology means for decentralized research
In late August of this year, the Decentralized Trial & Research Alliance (DTRA) announced the release of a glossary of industry terms and definitions. The DTRA is composed of many notable organizations, prominent DCT thought leaders, and stakeholders dedicated to “accelerating the adoption of patient-focused, decentralized clinical trials and research within life sciences and healthcare through education and research.” This glossary encompasses over 80 commonly-used terms in the decentralized clinical trial (DCT) space. Over the last several years, many DCT stakeholders have attempted to release terminology guides as it relates to their own dealings, however, there had never been a wide range of universalized DCT terms until now.
Why is it important to have universalized terminology?
Decentralized clinical trials are simply a model by which trials are run. This model can be applied to trials across various therapeutic areas and segments - from oncology to CNS to pharmaceutical to diagnostics. This means that there is a substantial amount of stakeholders that exist in the DCT space. These stakeholders include sponsors for all therapeutic areas mentioned above and much more, all DCT vendors and partners and services, clinicians, care providers, site staff who participate in these DCTs, operations teams that help design and execute trials, patients, and many more. All of these stakeholders exist within the DCT industry. Therefore, the alignment of terminology is essential for proper and effective communication and collaboration.
In order to run a clinical trial as effectively and safely as possible, it is vital to ensure all stakeholders are well aligned and well-informed. Misalignment in the understanding of a commonly used DCT term can result in significant trial setbacks and even patient safety concerns.
How does this glossary affect the industry?
The largest impact of the glossary will likely be seen on those who have used differing definitions and use cases for the terms included by the DTRA and how these terms will be used in the future. Those who have differing definitions for the terms which have been identified by DTRA will likely feel encouraged to readjust their usage to better align with the industry. When a prominent presence within the industry puts forth a glossary such as this, it is for the industry’s benefit and to conform will likely lead to fewer misunderstandings and difficulties in communications in research. It can be expected that many will adjust their usage and meaning to align with the DTRA glossary.
Furthermore, future research and decentralized clinical trials will likely implement the proper usage of the glossary’s terms. It is not unnecessary to expect that the terminology in the DTRA glossary will become widely used and accepted as the correct meaning. This can be attributed to some of the more grey areas in the FDA definitions when it comes to DCTs. Because this is the most clarity that has ever been offered to the DCT industry by a trusted industry representative, there may be very little pushback.
What are the terms included in the DTRA glossary?
Of these 80+ terms included in the glossary, many are well-known yet commonly ill-understood. This glossary includes a variety of terms that span from widely used to more niche and case-specific. Familiar terms such as clinical research study, clinical investigator, decentralized research, and caregiver were included. These more commonly agreed upon terms though, still remain important to include to ensure that there is a solidity to what the industry believes it already knows. By acknowledging the well-accepted terms the DTRA is confirming the usage within the industry and reinforcing that which may already be understood.
Common clinical research terms like informed consent, eCOA, remote site manager, and data clarification form were also part of the glossary's list. What is important to note about these terms is that they are likely used similarly in a non-decentralized space with the removal of additional words such as electronic, virtual, and remote. In this case, DTRA is helping DCT stakeholders to be able to make key differentiations between well-understood trial terms as it applies to DCTs. This can be extremely useful for clarification on clinical terms as many similar terms are identified by the FDA and other renowned research institutions but have yet to be done so as it relates to an electronic, virtual or remote setting.
Other more widely used terms were included as well such as telemedicine, interoperability, endpoint, and data management. These types of terms could arguably be some of the most important to include in the glossary because they are so commonly used outside of the DCT or clinical trials space. Because of this, simply searching the definitions of these terms can lead to a multitude of results all with various interpretations and existing in different industries. Not only does this glossary identify a unified definition for these terms but it also helps to differentiate how these terms fit into the DCT industry specifically and can help stakeholders understand the key differences between industry and non-industry uses.
How does this glossary impact Curebase and its customers?
Curebase is well-aligned with the DTRA glossary and will continue to take note of the unified terminology for future proceedings. Most importantly, Curebase is well-aligned with the glossary specifically as it relates to decentralized definitions. This is very important for Curebase because it validates the company’s innovative product and thought leadership pieces. To already be aligned with some of the most fundamental definitions for the decentralization of trials not only emphasizes Curebase's accuracy and dedication to growing the DCT industry but also sets an example for how many of these terms can be applied. Some of the glossary words this includes are listed below:
DCT Service/Solution Providers: “Companies that provide technology or service solutions for different aspects of DCTs including but not limited to: Trial Technology (e.g., ePRO, eCOA, telemedicine, eICF, Randomized Trial Supply Management, Clinical Supply Depot, EDC) Home Health Services Couriers Labs, Local Imaging Remote or Centralized Monitoring.”
Decentralized Clinical Trial (DCT): “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.”
Decentralized Research Methods: “Decentralized research methods include technologies (telehealth, wearables, remote clinical assessments), as well as processes (home health, local labs, local imaging, delivery of investigational drug product), used to create the opportunity to reduce or eliminate the need for participants to physically visit a traditional research site”
Hybrid Trial: “Hybrid clinical trials describe 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 Archetypes of Hybrid trials include (but are not limited to) the following: - Hybrid By Site: Trials where some participants participate at a traditional research site while others engage entirely via decentralized research methods - Hybrid By Visit: Trials 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”
To learn more about how these terms have been applied by Curebase in a way that aligns with the DTRA glossary, check out these pieces: Why "Decentralized" Doesn't Mean "Virtual" In Clinical Trials