THE FUTURE OF CLINICAL TRIALS DECENTRALISATION


With the emergence of COVID-19, Decentralisation of Clinical Trials became necessary to comply with social distancing requirements while carrying out clinical research. Over the past few years, the clinical trial landscape has shifted its focus to patient-centric practices to promote patient engagement. But now as the pandemic is long gone, it is time to reflect on how DCT studies are genuinely addressing long-standing issues in research and development for sponsors, study teams, and of course, the patients!
CROs to take the first step toward the future of clinical trials
Decentralised clinical trials involve a combination of innovative technologies with a patient-centric study design to communicate with study participants and collect data for conducting clinical studies using a hybrid approach
The primary goal of DCT is to provide a hybrid, flexible system that can promote high patient engagemen
Site-centred advertising targeting local participants
In-person consent, via physical signature
In-person physical tests
In-person recruitment
On-site treatment and check up where patients have to visit the site Low – due to scheduled in-person patient visits
Delayed – Requires final inperson visits
Digital advertising, allowing CROs to reach a diverse patient population. E-consent (digital consent signature) form patients located far away from the site Tele-consultation and home visits by medical personnel and nursing staff
Virtual recruitment Home healthcare and teleconsultation. Remote monitoring by devices and selfcare platforms
With the growing need for accelerated drug development, traditional sitecentric clinical trial models have evolved to handle consumer requirements during unforeseen events. According to recent data published by the Globaldata Pharma Intelligence Center, decentralised or remote clinical trials have successfully brought research closer to the patients, with an overall increase of 1.3% of all trials in 2011 to 2.5% in 2020.
Allows for a greater geographical reach, which is important for enrolling a diverse group of participants.
Eliminates the need for travel, which can be a barrier to participation.