Are Decentralised Trials Really the Future of Clinical Research?
Decentralised clinical trials (DCTs) have become one of the most discussed innovations in the world of clinical research. As pressures mount to improve participant access, increase diversity, and streamline study timelines, decentralisation is often seen as a natural solution. Leveraging technology to bring trials closer to participants, rather than requiring them to visit centralised sites, DCTs promise a more participant-centric approach, reducing the burden for participants.
In fact, recent data shows that an estimated 1,300 clinical trials in 2023 incorporated virtual or decentralised elements, marking a 28% increase from 2022 (1). Whether through hybrid designs or fully remote models, this trend highlights the rapid adoption of decentralised clinical trials.
Yet, the rise of decentralised trials is not without its complications. Can these trials really deliver on their promise, or do they introduce new challenges that could slow their widespread adoption? More importantly, are they the future of clinical research, or just another tool in an evolving landscape?
The Promise of DCTs
At the heart of decentralised trials lies the potential to transform how clinical research is conducted. Traditionally, participants are required to travel - sometimes long distances - to centralised research sites for assessments, treatments, and monitoring.
For many, this travel poses a significant barrier, particularly for those living in rural areas, those with rare diseases, or individuals with limited mobility. By allowing participants to engage from their homes or local healthcare settings, decentralised trials aim to remove these barriers entirely.
This accessibility doesn’t just benefit participants - it also allows researchers to reach more diverse populations. By eliminating geographical constraints, decentralised trials open the door to recruitment in underserved communities, ensuring that trial outcomes are more representative of the broader population. For years, diversity in clinical research has been a critical shortfall, with studies often skewed towards more affluent, urban, and predominantly white participants. DCTs offer a way to address this imbalance.
The potential for cost savings is also a powerful incentive for sponsors. Removing the need for large, centralised infrastructure and reducing participant reimbursements for travel and lodging could make trials more economical. Alongside this, investigators have found that the typical Phase II deployment of decentralised trials results in a one to three-month time savings, yielding a net benefit up to five times greater than the upfront investment. In Phase III studies, similar time savings yield a net benefit up to 14 times greater than the initial investment compared to traditional site-based models (2).
Coupled with advancements in remote monitoring technologies, such as wearable devices and mobile health platforms, decentralisation promises efficiency gains that extend beyond finances, including shorter timelines and real-time access to high-quality data.
These technologies do more than reduce costs - they redefine data collection. Wearable sensors, electronic participant-reported outcomes (ePROs), and advanced telemedicine platforms can capture data continuously, often in real-world settings. This provides researchers with dynamic insights into participants’ everyday lives, offering a depth of information that site-based trials often lack.
Navigating the Challenges
Despite these benefits, decentralised trials face considerable hurdles, particularly when it comes to implementation. One of the most pressing challenges lies in the regulatory landscape. While agencies such as the FDA and EMA have issued guidance supporting decentralised elements, there is no global consensus on how these trials should be conducted. Telemedicine regulations, data privacy requirements, and the validation of digital tools vary widely between regions.
For sponsors, navigating this fragmented environment adds complexity, cost, and risk. A recent LinkedIn poll conducted by MAC found that 45% of respondents identified regulatory complexity as the biggest challenge for their teams, underscoring the pressing need for streamlined guidance and international alignment (3).
Beyond regulatory hurdles, decentralisation also raises questions about control and consistency. Traditional site-based trials operate in controlled environments, ensuring uniformity in data collection. In decentralised trials, participants often collect data themselves - using wearable devices or completing self-assessments - introducing variability that can impact the reliability of results. Even small differences in how devices are used at home, or inconsistencies in reporting, can create challenges for researchers tasked with drawing conclusions from the data.
Access to technology further complicates matters. While DCTs are designed to improve accessibility, they can inadvertently exclude individuals who lack internet access, smartphones, or familiarity with digital tools (4). Potential participants are excluded from decentralised trials due to these barriers, creating a digital divide that disproportionately affects older adults and lower-income populations. This so-called “digital divide” creates new disparities even as others are reduced.
Much of the promise - and risk - of decentralised trials hinges on technology. Innovations such as artificial intelligence (AI), blockchain, and advanced telehealth platforms are shaping the way trials are designed and managed. AI, for instance, enables real-time analysis of participant data, identifying trends or anomalies that may require further investigation. Blockchain offers secure, transparent systems for managing participant data, ensuring privacy and reducing the risk of tampering. Telehealth platforms, meanwhile, allow for virtual consultations, bringing participants and investigators closer together despite physical distance.
Yet, these technologies come with limitations. Implementing AI systems or blockchain protocols requires significant investment and expertise. These tools must also undergo rigorous validation to ensure compliance with regulatory standards - an often lengthy and expensive process.
Perhaps the most significant challenge, however, is ensuring participant safety. Without immediate access to onsite medical teams, decentralised trials may struggle to respond promptly to adverse events or unexpected complications. This is especially concerning for trials involving investigational drugs with known risks, where close monitoring is essential.
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Decentralised vs. Traditional Trials
Decentralised trials have sparked significant debate about whether they will replace traditional models. In reality, the answer is more nuanced. Traditional site-based trials offer control and consistency that decentralised models cannot match. They are particularly well-suited for studies requiring complex procedures, specialised imaging, or immediate medical intervention. The infrastructure and oversight provided by centralised sites ensure participant safety and minimise variability in data collection.
Decentralised trials, on the other hand, excel in improving access and convenience. They are ideal for studies where remote monitoring and self-reporting are sufficient to meet protocol requirements. Rather than viewing these models as competing approaches, the research industry is increasingly recognising how they can complement each other. In many cases, hybrid models -combining decentralised and traditional elements - offer the best of both worlds, adapting to the needs of specific studies and participant populations.
Bridging the Gap: The Hybrid Model
Hybrid clinical trials present a balanced approach to modernising clinical research, offering a mix of site-based oversight and decentralised convenience. By blending traditional site visits with remote trial capabilities, this model addresses the logistical and engagement challenges often associated with fully decentralised trials. Hybrid trials enable participants to complete many trial activities from the comfort of their homes while still benefiting from the thoroughness and safety of site-based assessments.
Claire Horsgood, VP of Operations and Growth at MAC Clinical Research (MAC), underscores the importance of flexibility and participant-centric solutions:
This approach ensures flexibility for participants, reduces burdens such as frequent travel, and enhances access for diverse populations, ultimately leading to improved recruitment and retention rates. Furthermore, hybrid models leverage technology and tailored outreach strategies to ensure inclusivity, mitigate geographical and financial barriers, and optimise participant experiences while maintaining robust data quality.
MAC is ideally positioned as a CRO that also owns a network of investigator sites to deliver the advantages of a hybrid trial model with a personalised, participant-centric focus. Our MHRA-accredited Phase I centre in Manchester, combined with an expansive UK-wide research site network, provides the infrastructure to support seamless integration of remote and site-based activities. We are also uniquely placed to apply our extensive knowledge of challenges faced by investigator sites to support non-MAC sites with whom we contract.
Through MAC Remote Trial, we offer solutions that reduce the number of site visits for participants, lessen their burden, and maintain trial integrity. With advanced digital tools, culturally sensitive outreach campaigns, and a database of over 250,000 opted-in participants, we ensure no individual is excluded due to barriers like geography, financial constraints, or digital literacy.
Our comprehensive services, from pharmacy support to logistics and IMP administration, are designed to ensure trial success. Whether it’s preparing and delivering IMPs from our GMP-accredited facilities or conducting at-home reconstitution by clinical teams, our integrated approach facilitates efficient recruitment, reliable data collection, and a positive participant experience across all demographics.
A Fad or the Future?
So, are decentralised trials really the future of clinical research? The answer lies somewhere in between. For now at least, decentralisation is not a replacement for traditional methods but an evolution of them. For studies where accessibility, diversity, and convenience are paramount, decentralised trials offer a transformative approach. However, their limitations - particularly in terms of control, safety, and technology access - mean that they are unlikely to become the sole standard.
Instead, the future of clinical research will likely be defined by flexibility. Hybrid models that blend decentralised and site-based elements offer a balanced solution, allowing researchers to tailor their approach to the needs of each study. As the industry continues to innovate, decentralised trials will play an increasingly important role - not as a singular answer, but as part of a broader, more adaptable toolkit.
Decentralised trials represent an exciting shift in clinical research, breaking down traditional barriers and embracing new technologies. They offer the potential to reach more participants, collect richer data, and accelerate the development of new therapies. Yet, their challenges - regulatory, logistical, and technological - cannot be ignored.
For now, decentralised trials are a valuable tool, but not the definitive future of clinical research. By combining the best elements of decentralised and traditional methods, the research industry can move toward a more inclusive and efficient future. As innovation continues, the focus must remain on delivering high-quality, participant-centred trials that meet the needs of all stakeholders.
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Creative Writer at WHEELER CREATIVES. Retired clinical psychologist.
2wGreetings Richard. This was an interesting article. The issue of accessing a more divergent, and representative population is crucial for the ongoing validity of research. In psychology we have been blessed and cursed by the stage one undergraduate student population. The question being do such outcomes truly represent the population? I doubt it. Regards Richard No2.
General Manager at pps Ltd
2wI don't think that Decentralised trials will be the future but I can see were the Hybrid version could work in certain trials . over time I've done approx 50 trails of which a few could have been done from home