The Use of Decentralized Clinical Trials (DCTs)
November 26, 2025
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Modality Diversity, Target Selection, and Portfolio Strategy Creating a Perfect Storm of Complexity
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For biopharma leaders, clinical operations teams, and research organizations seeking data-driven insights into the current state, challenges, and strategic opportunities of decentralized clinical trials (DCTs).
This white paper summarizes the current decentralized trial (DCT) landscape informed by the results of a survey of 20+ top biopharma companies & contract research organizations (by revenue in 2024: 1 less than $1B, 7 between $1B to $10B, and 15 greater than $10B). Facilitated through a partnership between PACT (Partnership for Advancing Clinical Trials) and Scimitar, Inc., this survey is aimed at capturing the level of advancement in DCT adoption and experience across the pharmaceutical industry.
PACT is an organization founded in 2023 and facilitated by the Tufts University School of Medicine with the objective of establishing definitions and metrics for benchmarking DCT use and impact, gathering hard data on actual DCT use cases, and developing evidenced-based insights to inform DCT deployment strategies.
Scimitar, Inc., established in 2007, is a life sciences-focused management consulting firm that provides strategic industry insights and high-return solutions to clients ranging from healthcare service providers to top biopharma and medical device innovators.
DCTs are increasingly seen as a major strategic priority in clinical research, driven by the potential to improve patient participation, satisfaction, and diversity. Over the next five years, the use of DCTs is expected to expand significantly, as 75% of companies are considering hybrid DCT use a strategic objective and 100% anticipate the incorporation of DCT elements in more than 40% of trials (Figure 1). However, despite this growth, there are significant challenges that hinder the widespread adoption and optimal deployment of key DCT elements.
This white paper explores the strategic importance of DCTs, their expected patient benefits, the practical challenges involved, and the current state of implementation.
DCTs represent a significant shift in how clinical trials are conducted. The integration of decentralized elements, such as remote patient monitoring, telemedicine, and mobile visits, promises substantial improvements in patient engagement and access to trials. Over 75% of stakeholders in the industry view hybrid DCTs (a mix of in-person and decentralized methods) as a strategic objective, anticipating growth over the next several years. More than 90% of stakeholders acknowledge the expected benefits to patients, including enhanced participation, greater satisfaction, improved diversity, and broader access to trials. This aligns with the increasing demand for patient-centric trials, which are crucial to meeting the diverse needs of a global patient population. Despite this enthusiasm, it is apparent that there is room for growth — ~80% of companies self-categorized as being basic or ad-hoc in DCT maturity (Figure 2) — and stakeholders face practical challenges in fully utilizing DCT elements.
As companies transition toward hybrid models, they often encounter obstacles such as lack of consensus on DCT definitions, difficulties with technology implementation, regulatory uncertainties, and insufficient infrastructure to support remote trial elements. This has led to underutilization of key DCT features, preventing optimal patient experience and slowing progress toward more widespread adoption.
Although DCT adoption is growing — data indicates a focus on Phase II and III trials and shows good diversity across therapeutic areas — empirical data on its effectiveness and implementation remains sparse. Scholarly articles have provided limited insights into decentralized trials, largely due to the lower levels of adoption, highly customized implementations, and poor data collection practices in early trials. This lack of empirical evidence, coupled with the absence of standardized definitions and measurements for DCTs, has contributed to the slow pace of adoption and suboptimal deployment in practice.
Over 65% of companies do not deploy crucial elements of DCTs, such as online recruitment, patient portals, and remote consent, which are critical for the efficient operation of decentralized trials. Most report infrequent use of telemedicine, mobile visits, and wearable devices, which are essential for fully realizing the benefits of decentralization and enabling real-time monitoring and engagement. Furthermore, actual experiences with DCTs have been less than optimal. Nearly 69% of companies report DCT experiences as fair or poor, with only 31% rating their experiences as good. No companies reported experiences as excellent or very good, indicating a gap between expectations and outcomes (Figure 3).
The primary anticipated benefits of DCTs revolve around enhancing patient participation, satisfaction, and access to clinical trials. Over 90% of stakeholders agree that DCTs can improve these aspects, providing patients with greater convenience and reducing geographical barriers to participation. By allowing study visits and procedures to be conducted remotely, DCTs can also help shorten recruitment timelines and increase trial enrollment, particularly in underrepresented populations.
However, several practical challenges hinder the full realization of these benefits. Key barriers include:
Inability to Monitor ROI: Many organizations struggle to measure the return on investment (ROI) for DCTs, which complicates decision-making around resource allocation and justifying investment.
Costs: Despite the potential for cost savings in patient recruitment and trial management, upfront costs for technology infrastructure and training remain a concern for many stakeholders.
Technology Implementation: The deployment of new technologies, such as telemedicine, mobile visits, and wearables, has proven challenging. Issues such as technology integration, patient adoption, and data security remain significant hurdles.
Interestingly, while DCT usage is expected to result in longer cycle times due to remote study visits, actual data shows that cycle times are generally shorter — approximately 100 days shorter from protocol approval to database lock (DBL). This indicates that, when implemented successfully, DCTs can streamline trial timelines and reduce delays.
The adoption of decentralized clinical trials represents a major opportunity for improving patient access to clinical research, enhancing diversity, and reducing trial costs. However, the current experience with DCTs has been less than optimal, with underutilization of key components and several practical challenges impeding their growth. While the strategic priority for DCTs is clear, further investment in technology, process optimization, and standardized data collection practices is essential to overcome these obstacles. Only through addressing these challenges can the industry unlock the full potential of DCTs and drive greater innovation in clinical trial design.
In the coming years, it is expected that more companies will embrace hybrid models and fully decentralize trials, but success will depend on their ability to integrate these elements effectively and measure the associated benefits. As DCT adoption grows, it is essential for stakeholders to invest in the necessary infrastructure, training, and patient engagement strategies to ensure that trials remain efficient, patient-centered, and inclusive.
Zeid Barakat is a Partner at Scimitar Inc. with over 15 years of experience as a biopharma consultant and entrepreneur. He has experience leading initiatives across the critical value chain, including digital strategy, clinical operations enhancement, technical operations manufacturing and network strategy, CDMO and CRO partnerships, new product commercialization, and M&A / PE transactions. His work focuses on driving strategic, end-to-end transformation to accelerate performance and enable sustainable growth for clients.
T: +1 917-363-3438
zeid.barakat@scimitar.com
Michael Giroux is an Engagement Manager at Scimitar Inc. with over 7 years of experience as a life sciences strategy consultant. He has experience leading initiatives in process improvement, remediation, M&A lifecycle support, cross-functional analytics, and program management. His work focuses on regulatory, quality, and R&D transformation spanning the Pharmaceutical, MedTech, Biotech, and Medical Device industries.
T: +1 301-461-9320
michael.giroux@scimitar.com
Modality Diversity, Target Selection, and Portfolio Strategy Creating a Perfect Storm of Complexity
Modality Diversity, Target Selection, and Portfolio Strategy Creating a Perfect Storm of Complexity
Modality Diversity, Target Selection, and Portfolio Strategy Creating a Perfect Storm of Complexity
Modality Diversity, Target Selection, and Portfolio Strategy Creating a Perfect Storm of Complexity
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