Top 10 Clinical Trial Trends in the US in 2025

Clinical trials in the US are undergoing rapid transformation in 2025.

Driven by advances in digital technology, regulatory updates and growing emphasis on patient-centric design, sponsors and research organizations are rethinking how studies are designed, conducted and analyzed.

From the rise of decentralized trial models and wearable technology to the integration of real-world evidence and AI-powered data management, these trends are reshaping timelines, accessibility and efficiency.

Let us take a closer look at the top 10 clinical trial trends in 2025 shaping the US landscape.

1. Decentralized and Hybrid Trial Models

One of the most dramatic shifts is the move away from traditional, centralized trials to decentralized and hybrid models. Telehealth options and remote monitoring reduce travel burdens and expand access. For example, the decentralized clinical trial (DCT) market is forecasted to grow at a 14.16% compound annual rate (CAGR) between 2020 and 2030.

In 2024, Thread and Cogstate partnered to enable researchers to gather high-quality cognitive data remotely, which is especially valuable in neurology and psychiatry studies.

2. Wearable Technology and Digital Endpoints

In 2025, wearable devices have become critical tools for capturing real-time physiological data — such as heart rate, activity levels and sleep patterns.

For example, DATAcc by DiMe’s launch of core digital measures for Alzheimer’s disease and related dementias enables continuous tracking of cognitive and physical changes. This integration helps researchers make quick, informed decisions while reducing clinic visits.

The wearable technology market is projected to reach $885.65 billion by 2033, indicating a CAGR of 16.84%.

3. AI and Machine Learning

AI and machine learning are transforming clinical trials by streamlining data analysis and protocol design.

For instance, Caris Life Sciences recently published a study employing advanced AI to identify clonal hematopoiesis variants in over 16,000 cancer patients, enhancing patient selection. In addition, Suvoda’s new AI assistant promises to automate data monitoring and regulatory tasks, reducing manual workload.

4. Real-World Evidence (RWE) Integration

Researchers are increasingly incorporating real-world evidence — data from electronic health records (EHRs), insurance claims and patient registries — into trial designs. The EHR market is projected to reach $38.8 billion by 2030.

Target RWE expanded its TARGET Gastro Registry to over 30,000 patients to drive deeper insights into inflammatory bowel disease, while Elsevier enhanced its flagship ClinicalKey AI solution to integrate real-world data with clinical decision support.

5. Adaptive and Innovative Trial Designs

Adaptive trial designs enable modifications during a study, using pre-planned changes based on interim results to improve efficiency and reduce costs.

Cytel’s recently launched East Horizon Platform enables real-time, data-driven decision-making that optimizes study protocols. Meanwhile, PhaseV’s new AI/ML-powered trial design and analysis capabilities aim to tackle key challenges and reduce development timelines in clinical trials.

6. Emphasis on Diversity and Inclusion

Diversity is central to modern clinical trial design. Between 2018 and 2022, minority participation in trials rose by 25%, signaling progress in addressing long-standing gaps. Yet, a 2020 FDA report showed that 75% of trial participants for new molecular entities were white, with only 11% Hispanic or Latino, 8% Black or African American and 6% Asian.

As a result, these disparities have led the WHO and industry leaders to urge sponsors to move beyond baseline requirements.

7. Enhanced Patient Engagement and Experience

Clinical trials are evolving to be more patient-centered, with the digital era bridging the gap between participants and study teams.

For example, the collaboration between Quest Diagnostics and Google Cloud leverages generative AI to streamline data and tailor patient experiences, boosting retention and satisfaction. Similarly, ICON and Mural Health plan to use the Mural Link AI assistant — that delivers real-time updates, appointment reminders and study summaries — to keep participants informed throughout the study.

8. Regulatory Modernization

US regulatory bodies are modernizing oversight to keep pace with rapid advancements in trial technologies. The FDA’s revised Good Clinical Practice guidelines, based on ICH E6 R3 standards, now emphasize risk-based monitoring and real-time adverse event reporting.

New FDA guidance on AI and machine learning have mandated stringent algorithm validation.

The FDA’s Oncology Center of Excellence (OCE) has updated its guidance to include standardized tissue specimen collection to support biomarker-driven trials. The revised guidance also incorporates the monitoring of chemotherapy-induced peripheral neuropathy, which improves safety and data consistency in oncology studies.

9. Focus on Oncology and Rare Diseases

Oncology and rare disease trials are evolving rapidly, partly due to the increasing adoption of DCT methodologies. DCT approaches have overcome geographical and logistical barriers, leading to better patient recruitment and efficient trials.

The global oncology clinical trials market is projected to grow at a 5.28% CAGR from 2025 to 2034, while the number of rare disease trials continues to expand due to increased investment in precision medicine.

10. Operational Efficiency Through Collaboration

Operational efficiency is rising through strategic partnerships that leverage AI-driven solutions.

For instance, Grove AI recently received the SCOPE Participant Engagement Award for its digital staff and integrated platform that automates participant communications and real-time data capture. Additionally, Intrinseque Health and Good AI have partnered to deliver AI-powered clinical supply chain solutions, employing predictive analytics to optimize inventory management and reduce operational disruptions in trials.

Global Clinical Trial Trends in 2025

While the US is spearheading many clinical trial trends, global uptake is also accelerating.

In Europe, the European Medicine Agency’s (EMA’s) unified trial portal and recent approval of AI tools for fatty liver disease studies are streamlining cross-border research.

Across Asia, rapid growth in early-phase trials in China is being driven by partnerships with Western pharmaceutical firms seeking faster development pathways. For example, Novotech collaborated with Kyungpook National University Hospital in South Korea to strengthen access to advanced trial infrastructure, offering site training and regulatory support, thereby enhancing regional study capabilities.

Meanwhile, emerging markets like India face pressure to update clinical trial regulations, hoping to spur investment in infrastructure and attract global sponsors.