Posted: 9 June 2023
ARCS Australia has released a white paper to define common terms used in decentralised clinical trials providing a common and consistent language for the sector. The paper was released on day two of the 2023 ARCS Annual Conference currently underway in Sydney.
During COVID the ability to access clinical trials, including in rural and remote settings and by vulnerable patient cohorts, became increasingly challenging due to the state and jurisdictional hospital requirements. The sector responded rapidly to the challenge to ensure clinical trial visits were conducted and participants’ safety and wellbeing was maintained. This led to parts of traditional clinical trials converting to a decentralised approach. Post COVID there was no turning back the clock and participants wanting to continue and expand on decentralised trial design. Decentralised clinical trials have been enabled by innovative trial designs and the increasing availability of digital technologies to support their conduct.
However, the rapid implementation of decentralised trials soon led to a lack of a clear understanding and defined terminology in relation to different clinical trial designs and what that meant to the different stakeholders. This is a potential barrier to their conduct and may lead to potential delays in participants accessing clinical trials.
ARCS took the initiative and brought together key stakeholders and experts from various disciplines and held a summit in Melbourne to discuss decentralised trials in Australia. Resoundingly the key outcome of the summit was to have an agreed terms and definitions which were applicable to the Australian regulatory framework. A working group defined essential terms and established agreed common terminology. The white paper on Common Terminology for Decentralised Trials is a result of this consultative approach.
The terms and definitions are consistent with international terminology and align with the Australian regulatory framework for clinical trials.
The white paper has been developed to provide guidance for those involved in the design, conduct or oversight of clinical trials to ensure all stakeholders have a clear understanding on how the trial is to be conducted and to support effective communication with agreed understanding of terminology.
The white paper provides a consistent and standardised approach to decentralised trials, positioning Australia as a global leader in this field.
A copy of the white paper is available here.
