Clinical trials are entering 2026 with a clear shift toward adaptive design, digital data capture and more globally distributed research footprints.
HopeAI showed recently that AI-generated synthetic patient data can validate surrogate oncology endpoints in weeks instead of years, suggesting a faster pathway for regulatory-grade evidence.
So where are we headed?
ClinicalTrials.gov now lists over 558,000 registered studies, with interventional trials representing about 76% of all registrations. Roughly 56% of these studies take place outside the US, compared with 29% that are US-only.
In 2025 alone, 37,597 new studies were added.
In this blog, let’s take a deeper dive into the trends shaping how studies were run in 2025, and how they will be designed in 2026.
FDA and Regulatory Evolution: Mechanism-Driven Evidence and Remote Data Acceptance
Regulatory actions across 2025 showed the FDA’s openness to smaller, biologically anchored data sets and validated remote assessment methods.
2025 example:
FDA’s new “plausible mechanism” pathway outlined how highly personalized therapies for severe genetic diseases may be evaluated through small studies supported by strong biological rationale and natural history comparators. Several rare disease developers have already begun redesigning Phase I/II protocols to align with this model, leaning more heavily on biomarkers, functional assessments and mechanistic linkage rather than large sample sizes alone.
Hybrid and Decentralized Trial Models Becoming Mainstream
Hybrid models shifted from optional to expected in 2025, especially where mobility, geography or time constraints limit participation.
2025 example:
Curavit Clinical Research acted as the virtual clinical site for the APPROVE trial, a decentralized study evaluating Amara Therapeutics’ RiSolve digital therapeutic for overactive bladder in women. Using its STRATUS virtual site platform to manage screening, e-consent and follow-ups, Curavit demonstrated how specialist DCT partners can streamline operations and expand access beyond traditional brick-and-mortar sites.
AI, Automation and Robotics Embedded Across Trial Workflows
AI adoption widened across feasibility modeling, data cleaning and endpoint review. Robotics has also advanced how device trials are assessed.
2025 example:
Cleveland Clinic expanded its use of Dyania Health’s Synapsis AI after pilots in cardiology, oncology and neurology showed the platform could scan unstructured clinician notes and flag eligible patients faster than manual pre-screening. The rollout could speed recruitment, improve protocol matching and reduce site workload by converting free-text records into structured insights for trial teams.
Digital Biomarkers and Continuous Monitoring Gaining Ground
Sensor-based data continued moving into early- and mid-phase trials, particularly in neurology, pulmonary disease, cardiology and metabolic research.
2025 example:
Empatica’s EmbraceMini, a compact, USB-sized actigraphy wearable, launched in June 2025. Designed for long-term comfort, it collects over 200 measures related to sleep, movement, gait and light exposure, transmitting data to Empatica’s FDA-cleared platform. Its size and week-long battery life are intended to support continuous monitoring across diverse therapeutic areas.
Adaptive, Bayesian and Seamless Designs Accelerating Evidence Generation
Innovative statistical designs continued to expand as sponsors sought to reduce amendments and accelerate decision-making.
2025 example:
Cook MyoSite partnered with Veristat on a complex Phase III adaptive study of an investigational cell therapy for a women’s health indication. The design allows adjustments based on interim data, giving the team flexibility to refine dosing and sample size while maintaining statistical rigor. This is an approach aimed at speeding evidence generation in an area with limited treatment options.
Real-World Data (RWD) and Real-World Evidence (RWE) Integrated Into Trial Planning
Sponsors increasingly paired RWD with traditional trial data to strengthen external validity and reduce participant burden. Regulators signaled a similar direction.
2025 update:
In June 2025, the NIH and FDA jointly published a glossary of terms related to innovative clinical trial designs, including methods that use real-world data to generate real-world evidence. The glossary defines 40 terms covering pragmatic trials, observational approaches and RWD-driven methodologies to align terminology across sponsors, investigators and regulators.
Site Enablement and Workforce Technology to Reduce Operational Friction
Staffing shortages, rising documentation needs and protocol complexity continued to strain sites. Technology adoption shifted from “nice to have” to essential.
2025 example — YPrime (eCOA localization):
In 2025, YPrime reported that its AI-enabled eCOA localization workflow reduced migration errors by 74%, decreased error-containing screen reports by 60% and shortened review cycles by 67% across 15 studies in 11 languages.
2025 example — ProofPilot × Lokavant (predictive analytics):
In September 2025, ProofPilot acquired Lokavant to integrate predictive analytics into its trial-execution platform. The combined system offers forecasting, feasibility modeling and early detection of operational risks, helping teams anticipate issues before they affect timelines.
Protocol Simplification and Participant Burden Reduction
Sites and sponsors continued to streamline logistics as dropout rates remained a major barrier to timely completion.
2025 example:
In October 2025, Suvoda launched a unified patient mobile app that brings visit scheduling, questionnaires, travel information and reimbursement tracking into a single interface. The design aims to reduce the logistical burden that often leads to dropout, aligning with CISCRP’s 2025 findings that 63% of participants find smartphone apps for study tasks very helpful.
Across 2026, clinical research will continue moving toward flexible trial design, digital data capture, site-level automation and globally distributed enrollment.
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