The landscape of clinical research is undergoing a seismic shift with the rapid evolution of decentralised clinical trials (DCTs). What started as an initiative to improve patient access to trials has now turned into a paradigm-shifting approach that enhances trial data quality, patient engagement, and inclusivity in clinical research.
The data from a survey indicated that decentralised approaches have been adopted by 94% of research sites and among these sites, 88% have implemented hybrid trials that combine remote technological elements with in-person site visits.
Express Pharma, in a recent post, highlights the evolution of DCTs. The article also underlines the key developments within the DCT sector, such as enhanced trial data quality, amplified patient engagement through remote visits and eConsent, and their broader application across a diverse range of diseases and conditions.
Underscoring the patient-centric approach of these trials, the article emphasises the role of DCT and hybrid trial models in eliminating geographical barriers and empowering patients to participate in trials from the comfort of their homes.
The article attributes the recent increasing adoption of DCTs to a convergence of factors driving fundamental shifts in the clinical research landscape. The integration of decentralised elements, such as mobiles, telemedicine, wearables, sensors, electronic health records (EHRs), etc, has democratised remote patient monitoring (RPM) and remote data acquisition within DCTs. Mobile devices, sensors, and wearables allow participants to transmit real-time health data and symptoms to the trial researchers from the comfort of their homes. In addition, telemedicine platforms facilitate virtual consultations, eliminating the need for in-person appointments. Electronic health records (EHRs) securely share patient information between healthcare providers and trial sponsors, contributing to seamless data collection.
Additionally, addressing challenges often faced by traditional clinical trials, DCTs provide a tangible solution to patient enrolment and retention. Recent findings from a survey conducted by the Center for Information and Study on Clinical Research Participation (CISCRP) unveiled a startling statistic: approximately 14% of participants fail to complete an entire clinical trial. The repercussions of this high loss-to-follow-up rate are far-reaching. They jeopardise the integrity and validity of clinical trial outcomes.
By offering improved accessibility and reducing the logistical complexities associated with in-person visits, DCT platforms that include eConsent, eCRFs, and ePro, such as ObvioHealth, widen the participant pool and enhance diversity in clinical trials. The article highlights how DCTs contribute to improved patient retention by offering a patient-centric experience that alleviates burdens and facilitates patient engagement.
The article also sheds light on the plethora of benefits DCT and hybrid study models offer compared to traditional on-site trials. Enhanced patient access and convenience, augmented patient retention, cost-savings, time efficiency, real-time data collection, and analysis, refined data quality and analysis, and greater flexibility have been highlighted among the advantages that DCTs bring to the table.
As the article delves into the future of DCTs, it anticipates several trends that will shape the landscape of clinical research. Hybrid trial designs that combine traditional and decentralised approaches are anticipated to cater to the unique requirements of each study. Virtual Health Assistants (VHAs) are set to play a vital role, providing personalised guidance, remote monitoring, and support to trial participants. Wearable and remote monitoring tools, blockchain technology, and generative AI are expected to further augment the capabilities of DCTs. The article highlights the importance of regulatory advancements in driving the adoption and approval of DCTs, stressing the collaborative efforts of regulatory agencies in developing DCT frameworks and guidelines.
As the landscape of clinical research continues to evolve, decentralised clinical trials stand at the forefront of innovation, promising to reshape the way medical research is conducted and bring about transformative benefits for patients, researchers, and the entire healthcare ecosystem.
Sohela is an electrical engineer and a self-professed writer with a keen interest in all things tech. When she’s not writing killer content pieces, you’ll find her enjoying tempting foods in her favourite restaurants.