The Challenges and Change Management Approaches, Considering Trial Designs and Timelines with Decentralisation Methods at the Forefront
While components of fully decentralised clinical trials and hybrid decentralised clinical trials existed prior to the COVID-19 pandemic, the ongoing public health crisis accelerated the demand for DCTbased approaches. During COVID-19, the pharmaceutical industry was focused on managing participant safety and ensuring data integrity for COVID-19 vaccine trials and other ongoing traditional trials, many of which were put on hold due to the inability of participants to travel to sites in the traditional trial model. Kamilla Posselt, Isaac Rodriguez-Chavez and E.B. McLindon at ICON plc. explain the challenges that need to be considered on trial designs and timelines with decentralisation methods at the forefront.
‘Operationalising Decentralised Clinical Trials (DCTs)’
The issue is that industry in many instances is still approaching trials in the same way as practiced for the past twenty years with the expectation that the new communication technologies, digital health technology tools, and operational processes will fit into the same mould and follow the same timelines as a traditional trial with in-person visits to traditional sites. For instance, some sponsors utilise certain remote participant assessment instruments supported by technology such as electronic Patient Reported Outcomes (ePROs) as an add-on instead of building it into the initial protocol design as part of the trial strategy and data architecture. DCT components, such as digital health technologies (i.e., wearable devices), communication technologies (i.e., telehealth visits via videoconference) and/ or inhome clinical services (i.e., home health nursing services), are not being added until the later stages of protocol development thereby creating challenges to operationalising the final protocol and impacting overall feasibility. By not having a cohesive DCT strategy that considers the wider perspective of trial endpoints, participant journey, data architecture that is fit-for-purpose, and regulatory requirements across multiple jurisdictions, trial inefficiencies will continue occurring such as trial delays due to enrolment and retention issues and inefficient use of DCT components. Persistent inefficiencies may be observed at the participant, research site staff and sponsor level unless changes occur to adopt DCT principles as customised solutions.
For our industry to transform to DCTs there is a need for new methodologies that incorporate protocol development, enable the customisation of individual trials and an acknowledgement that over time traditional trial activities, framework and roles will be changed or replaced.
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