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!
The digital shift in clinical trials has brought about the potential to improve both patient experience and clinical data quality significantly. Understanding the direct implications of decentralized approaches can positively impact research outcomes, allowing CROs to take the first step toward the future of clinical trials. DCTs have paved the way for the clinical trial industry to adapt quickly to meet consumer needs while mitigating risks and maintaining participant safety.
What is a decentralised clinical trial?
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. DCTs leverage remote monitoring and data capture technologies such as eConsent, eDairies, ePRO, Tele Consulting, Direct-to-Patient, Wearables, etc. to make participating in clinical trials easier.
The primary goal of DCT is to provide a hybrid, flexible system that can promote high patient engagement. By reducing drop-out rates, and increasing study effectiveness, DCTs ultimately reduce time-to-market for life-saving medicines – positively impacting millions of potential patients.
Traditional trials vs Decentralised trials
Here’s a stage-wise comparison between a conventional and decentralized clinical trial:
|Patient Selection||Site-centered advertising targeting local participants||Digital advertising, allowing CROs to reach a diverse patient population.|
|Participant consent||In-person consent, via physical signature||E-consent (digital consent signature) form patients located far away from the site|
|Screening||In-person physical tests||Tele-consultation and home visits by medical personnel and nursing staff|
|Enrollment||In-person recruitment||Virtual recruitment|
|Treatment and follow-up||On-site treatment and check up where patients have to visit the site||Home healthcare and teleconsultation. Remote monitoring by devices and self-care platforms|
|Patient retention||Low – due to scheduled in-person patient visits||High – as it allows remote trial participation for patients, via Telemedicine|
|Study conclusion||Delayed – Requires final in-person visits||Faster conclusion – Returning of study equipment signifies the end of the clinical study|
Why decentralised clinical trials are the way of the future?
With the growing need for accelerated drug development, traditional site-centric 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.
The decentralised model has several advantages over the traditional, centralised model of clinical trials.
- 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.
- Enables site staff to be more directly involved in the trial, which can improve retention and compliance.
High-quality clinical research outcomes can only be achieved when clinical excellence and technology are combined. Choosing Clinion eClinical platform is the key to opening the treasure box of tangible decentralised components that when incorporated into your study can enable you to reach out to a diverse patient base, increase patient access and streamline data collection. From ensuring compliant delivery and reducing the patient burden to increasing patient engagement, Clinion’s AI-enabled software can help you achieve successful DCT implementation via a seamless interplay of direct-to-patient services.
If you are looking to expand trial capabilities, upgrade data quality, and increase patient compliance rate, then choose the right eClinical platform to optimise regulatory strategy and new processes and leverage futuristic data-management models, today.
Clinion is a life sciences technology company offering innovative software solutions in
the pharmaceutical industry since 2010. Our first product, also called Clinion, is an
integrated eClinical trial platform for small and medium CROs, academic research
organisations and pharmaceutical companies.
Clinion is an AI-enabled eClinical Platform consisting of an Electronic Data Capture (EDC), Randomisation and Trial Supply Management (IWRS/RTSM), Patient Reported Outcomes (eCOA) and Clinical Trial Management Systems (CTMS).
We envisage Clinion to be the AI-enabled eClinical platform of choice for small and medium CROs, and academic and pharmaceutical organisations in the global market.