Decentralised Clinical Trials
Transforming the future of patient-centric research
Aarti Chitale, Principal, Healthcare & Lifesciences, Frost & Sullivan
Decentralised clinical trials (DCTs) are revolutionising clinical research by aiding patient recruitment through remote modalities. A greater application of digital health technologies in the form of e-clinical solutions and AI/ML platforms are seamlessly identifying the right patient groups, whilst reducing logistical burdens and expediting study timelines. Additionally, hybrid models combining traditional and decentralised approaches are increasingly popular, offering flexibility and efficiency. Recent guidelines from the USFDA and EMA endorse DCTs, emphasising patient-centric designs and data integrity. Innovations like telemedicine, wearable devices, and electronic consent are pivotal in this transformation, ensuring robust data collection and improved patient engagement.
With patient centricity at their core and supported by a conducive regulatory landscape, decentralised clinical trials (DCTs) are fast emerging as a transformative force in modern clinical trials. From reshaping patient recruitment and site selection to enabling real-time data capture and global participation, DCTs are unlocking new possibilities through advanced technologies and regulatory innovation- creating a completely new model of Patient Consumerism.
Why now? The urgent need for a new clinical trial paradigm
Can the industry afford to keep relying on legacy models in an age of hyperconnectivity and AI?
The traditional model of clinical trials—heavily reliant on physical sites, manual data collection, and geographically limited recruitment—has long suffered from inefficiencies. Patient dropout rates, logistical delays, and mounting costs have pushed stakeholders to seek more inclusive and adaptive solutions.
Enter DCTs, a model built on patient centricity, digital enablement, and regulatory momentum. By minimising the need for physical site visits and leveraging mobile health tools, DCTs are revolutionising the way clinical trials are conducted.
Back to the beginning: How DCTs took root
Having found their footing in the early 2000s, DCT have created significant opportunities to streamline clinical trial processes and timelines for pharma sponsors and Contract research organisations (CROs) alike. The first fully decentralised clinical trial was conducted by Pfizer in 2011, enrolling 600 patients across 10 US states, laying the foundation for future advancements. When the COVID-19 pandemic disrupted clinical research in 2020, monthly trial startups dropped by 50 per cent, forcing the industry to rethink traditional models. As an outcome, direct-to-patient drug and supply delivery, along with mobile devicebased data capture, gained popularity, further augmenting DCT adoption.
Peeking into the present: Where do we stand?
The DCT model is swiftly gaining popularity, with industry surveys suggesting that 50 per cent-70 per cent of industry stakeholders are integrating at least one DCT element into their Phase 3 trials. Electronic clinical-outcomes assessment (eCOA), electronic patient reported outcomes (ePRO), remote and central site monitoring, remote site pre-activation, patient pre-identification are amongst the most sought-after services within the DCT model.
Patient recruitment continues to be one of the most formidable challenges in clinical trials. Common impediments include insufficient awareness, geographical limitations, and rigorous eligibility criteria. Globally, approximately 50 per cent of the clinical trials are terminated owing to inadequate recruitment, with Phase III and IV trials achieving an average enrollment success rate of less than 50 per cent. Industry reports cite that 80 per cent of clinical trials fail to meet their enrollment timelines, critically impacting overall trial schedules.
By minimising the necessity for physical site visits, DCTs enhance patient participation in remote or underserved regions through the utilization of mobile devices. Whilst empowering Pharmasponsors, DCT models also rely on data analytics solutions and platforms to aid strategic site selection — targeting areas with higher patient density and better infrastructure-thereby enabling trial sites and investigators. In this context, the adoption of sophisticated platforms such as eClinical solutions, artificial intelligence (AI) and machine learning (ML) tools, predictive analytics, and cloud based data systems is accelerating globally. Complementing dedicated DCT providers like Medable, THREAD, and Science 37, technology leaders including Unlearn, Owkin, Medidata, Veeva Systems, and Oracle Cerner are instrumental in driving broader implementation and scalability of the DCT model.
Tech-Enabled Trials: AI igniting the next frontier in DCTs
As emerging technologies like AI/ML become integral to clinical research, the imperative to address data security and privacy concerns has never been greater. Despite these challenges, organisations are increasingly implementing advanced safeguards such as end- to-end encryption, granular access controls, and secure data governance frameworks—to ensure the integrity and confidentiality of sensitive information. Beyond compliance, these technologies are creating transformative opportunities for pharmaceutical companies and contract research organisations (CROs) to streamline clinical trial processes. Through the deployment of intuitive, interoperable platforms, AI and ML are enabling smarter, faster, and more patient-centric research, reshaping the future of clinical development.
Precision recruitment: How can AI turn recruitment from a guessing game into precision science?
AI is revolutionising patient recruitment by turning digital footprints into actionable insights. Advanced platforms seamlessly aggregate patient data from electronic health records, online support communities, social media conversations, and advocacy networks—creating a realtime pulse on patient intent and eligibility. Innovators such as TrialWire, Unlearn, Deep 6 AI, and Deep Lens are deploying sophisticated predictive and prognostic enrichment algorithms to match patient profiles at both genotypic and phenotypic levels. These precision tools not only accelerate recruitment timelines but also ensure that enrolled cohorts are optimally aligned with study criteria, driving both efficiency and scientific rigor.
AI-driven site intelligence for smarter trials
Strategic site selection has become increasingly data-centric, with AI models harnessing region-specific epidemiological trends, real-world data (RWD), and historical trial performance to identify optimal research hubs. These intelligent systems synthesize multi-source data— ranging from investigator track records to population health indicators—to prioritise high-performing sites and investigators that align with protocol requirements. Platforms developed by leaders such as Medidata, Inato, and Deep 6 AI centralise site intelligence, providing sponsors, investigators, and CROs with real-time access to harmonised datasets. This not only enhances transparency and coordination but also enables dynamic site activation and more agile trial execution.
Global Regulatory tailwinds: Enabling DCT at scale
Are regulators evolving quickly enough to match the pace of digital innovation?
The regulatory landscape surrounding DCTs has undergone a significant transformation in recent years, marked by a series of strategic initiatives across major global markets. In the United States, the Food and Drug Administration (FDA) began formalising its commitment to DCTs in 2018 by establishing dedicated working groups responsible for drafting guidance on decentralized models. A major milestone followed with the December 2020 launch of the Decentralised Trials and Research Alliance (DTRA), uniting over 50 international stakeholders—including the FDA and patient advocacy groups—to accelerate the adoption of DCT methodologies. In tandem, the FDA also established the Digital Health Center of Excellence to advance digital health technologies (DHTs), such as mobile health tools, Software as a Medical Device (SaMD), and medical-grade wearables.
By 2024, the FDA issued comprehensive final guidance that consolidated and updated prior recommendations on both DCTs and DHTs. These guidelines clarified expectations around hybrid trial designs, balancing telehealth and in-person visits based on investigational product characteristics, participant conditions, and data collection modalities.
Internationally, regulatory agencies have demonstrated similar momentum. In July 2020, China's National Medical Products Administration (NMPA) released guidelines addressing DCT components such as remote monitoring, electronic informed consent, and direct-to-patient drug delivery. By 2022, China’s Center for Drug Evaluation (CDE) issued draft guidelines focused on patient-centricity, clinical outcomes assessments, and DCT protocols—aligned with the country’s broader data protection regulations under the Cybersecurity Law, Data Security Law, and Personal Information Protection Law.
In Europe, the European Commission updated its COVID-19 trial management guidance in 2021 and, by 2023, launched processes to facilitate largescale, multinational DCTs. Notably, the Danish Medicines Agency issued guidance promoting DCTs, supporting the integration of AI, eClinical technologies (eConsent, ePRO), and digital platforms— fostering greater efficiency, data integrity, and participant- centric trial designs across the continent.
Investment trends: Who’s fueling the DCT ecosystem?
As DCTs continue to gain momentum, the industry is witnessing a strategic shift in investment patterns aimed at enhancing operational efficiency, expanding patient access, and building long-term capabilities. Stakeholders across the clinical research value chain are adopting a multi-pronged approach, anchored in collaboration, internal capability building, and knowledge-driven partnerships.
• In-house capability enhancements for end-to-end delivery: Organisations are investing in the vertical expansion of their in-house capabilities to reduce dependency on external vendors and ensure seamless trial orchestration. ObvioHealth, a digital clinical trials company, unveiled
• ObvioGo® 2.0, a next-generation platform and mobile application designed to support adaptive, site-specific study configurations, aligned with evolving sponsor requirements.
Strategic Alliances for Capability Expansion and patient reach:
1. To bridge infrastructure gaps and improve trial accessibility, leading DCT players are forming cross-functional alliances. A recent example is the launch of the Medable Partner Network—a comprehensive ecosystem initiative in collaboration with PPD (Thermo Fisher), CVS Health, Cognizant, and Advanced Clinical. This network integrates technology, site operations, data solutions, and direct-to-patient services to streamline DCT delivery and scale execution globally.
2. Beyond operational gains, partnerships are increasingly viewed as vehicles for knowledge exchange and innovation acceleration. In 2024, Fortrea, a global contract research organisation, launched its AI Innovation Studio, offering customised artificial intelligence solutions for patient identification, trial enrollment optimisation, and real-time data capture, underscoring the industry's growing focus on intelligent automation and patientcentric design.
The road ahead: The age of agile, inclusive, and intelligent trials
DCTs have created a paradigm-shift, revolutionising clinical research through patient-centric design, robust regulatory frameworks, and avant-garde technologies. By harnessing the power of artificial intelligence (AI), predictive analytics, and digital platforms, DCTs are overcoming critical obstacles and democratizing trial access, enhancing patient engagement whilst optimising trial efficiency with inclusive trial outcomes. Strategic investments and cross-sector alliances are propelling innovation and scalability across the clinical trial ecosystem. The future of clinical trials is not only decentralised—it is data-driven, adaptive, and fundamentally patient-first.
Author Bio
Aarti Chitale a Principal with Frost & Sullivan's Healthcare and Life Sciences Practice, holds about 15 Years of experiences in the industry across disease intelligence and environmental scan, regulatory and legislative assessment, competitive intelligence and benchmarking.
She is particularly focused on services sector of the Pharma industry which includes Pharma Contract Services, Pharma Commercial IT solutions as well as Technology Enabled Drug Discovery and Development landscape. Aarti is responsible for identifying and analyzing key market opportunities, competitive benchmarking of key stakeholders and helps build thought leaderships across various vendors services across the Pharmaceutical Industry.
