Activities & Operations
What approaches can we use to move trial activities towards participants’ homes?
What approaches can we use to move trial activities towards participants’ homes?
Several approaches have been used in DCTs to move trial activities towards participants’ homes. A selection of these, which were used in RADIAL, are shown in the figure below. Others include postal or telephone contact…
Remote recruitment and (pre-)screening
Participant diversity and representativeness
Economic insights when introducing decentralized trial elements
Economic insights when introducing decentralized trial elements
Setting up and conducting clinical trials is costly, and concerns have been raised that expenditures are expected to increase. DCTs have the potential to achieve cost-savings, if they can accelerate patient recruitment and improve retention…
Patient Considerations & Involvement
What motivates people to participate in a clinical trial (from home)
What motivates people to participate in a clinical trial (from home)
DCTs are expected to be less burdensome for participants than conventional trials, as travel to the site is reduced or eliminated and trial visits can be carried out from the participant’s home or immediate vicinity by applying digital technologies.
Assessment & Approval
The EU Regulatory landscape regarding DCT
The EU Regulatory landscape regarding DCT
Prior to the implementation of the Clinical Trials Regulation (EU No. 536/2014), clinical trials in the EU were governed by EU directives (2001/20/EC, 2005/28/EC) and national laws, with variability across Member States (MS). In 2022, the Clinical Trials Regulation (CTR) became mandatory in all MS…
Overarching ethical considerations for DCTs
Overarching ethical considerations for DCTs
All clinical trials require ethical review, including DCTs. However, the regulatory and ethical review system was designed for conventional (site-based) trials. To fully realise the promises of DCT approaches, the ethical context needs to be aligned with the practice of DCTs to safeguard responsible conduct.
Health Technology Assessment awareness regarding DCTs
Oversight & Clinical Management
DCT readiness and training of clinical study staff
DCT readiness and training of clinical study staff
In conventional trials, sites traditionally serve as central locations for patient recruitment, monitoring and data collection, and regulatory compliance. In a DCT these traditional roles change, shifting some trial activities away from sites to remote settings.
Privacy & data protection
Privacy & data protection
The successful and sustainable adoption of DCTs hinges on robust data privacy and protection measures. Moving trial activities outside traditional research sites significantly increases the complexity of data flows and amplifies privacy and data protection challenges, such as participant personal data being shared to third party service providers.
PI responsibilities, oversight and safety reporting
PI responsibilities, oversight and safety reporting
PI responsibilities are the same in DCT approaches as they are in any trial. And requirements for oversight and safety reporting need to be neither higher nor lower than in conventional clinical trials. However, different tools may be used to guarantee oversight when participants come to site less or not at all.
Technology & Support
Technology Components
Technology Components
Digital tools in DCTs can improve real-world data collection, reduce participant travel, and offer more flexible engagement. However, there are challenges that come from integrating technology into trials: (1) reliance on cutting-edge yet immature technologies, (2) increased trial complexity, and (3) potential overload for clinical sites and participants.
DCT technical support system for sites and trial participants
DCT technical support system for sites and trial participants
Decentralized clinical trials (DCTs) involve a range of digital tools provided to ….. Often these tools are provided by different, specialised vendors, which can complicate support and coordination. To address this, the RADIAL trial implemented a centralized technical support system for study teams, site staff, and clinical research associates (CRAs).