More than half of 381,000 clinical trials showed execution risk, SASI analysis finds

Cognitive Code said TrialSite News published SASI findings from an analysis of 381,187 interventional clinical trials that found 53.2% showed execution-risk exposure. The results highlight disclosure gaps, trial delays and therapeutic-area differences that could affect development costs, patient access and regulatory oversight.

Why it matters: - The analysis suggests clinical-trial risk is broader than trial termination alone. - More than half of the 381,187 interventional trials reviewed showed some form of execution-risk exposure. - The findings point to disclosure discipline and operational execution as a system-level issue in clinical research. - Delays and missed reporting can raise development costs, extend site and CRO commitments, delay patient access and reduce the value of patented therapies.

What happened: - Cognitive Code said findings from the SASI initiative, powered by the SILVIA deterministic AI platform, were published by TrialSite News. - The benchmark reviewed 381,187 interventional clinical trials from publicly available ClinicalTrials.gov, AACT and FDA datasets. - TrialSite News published the analysis on June 23, 2026. - The publication gives the SASI methodology independent editorial validation in a clinical research media outlet.

The details: - SASI identified 53.2% of analyzed trials as having execution-risk exposure. - Hard-failure events included 43,757 studies that were terminated, suspended or withdrawn. - Disclosure-risk events included 159,215 completed studies that did not post results within SASI's FDAAA-801-based reporting framework. - Disclosure-risk events were more than three times the rate of outright trial failure. - Among 187,483 completed interventional studies, the median time from submission to primary completion was 20 months. - Among 65,022 commercial studies, 58% exceeded their originally registered completion targets. - Execution-risk exposure varied by therapeutic area. - Cardiovascular studies showed the highest exposure rate at 48.2%. - CNS and neurological disorder studies followed at 41.6%. - Oncology studies recorded 40.5% exposure. - Immunology and rare-disease programs showed comparatively lower exposure. - The benchmark was designed to be fully reproducible and auditable, with all metrics derived from source records. - SILVIA uses deterministic architecture rather than probabilistic AI, producing consistent and traceable outputs. - Cognitive Code described SILVIA as a platform built for regulated industries that need accountability, traceability and confidence in how conclusions are reached.

Between the lines: - The headline risk may not be trial failure itself, but the large volume of studies that finish without public results disclosure. - That pattern suggests sponsors, sites and regulators may be dealing with a reporting gap that is less visible than termination rates but potentially just as important. - The therapeutic-area spread hints that operational risk is uneven across development categories, which could affect portfolio planning and oversight priorities. - Daniel O'Connor, founder of TrialSite Inc. and a SASI board member, said execution can now be measured objectively, transparently and at scale.

What's next: - Cognitive Code is positioning SILVIA and SASI as tools for sponsors and stakeholders seeking risk intelligence across the clinical-trial ecosystem. - TrialSite News is hosting the full benchmark analysis at the full SASI benchmark analysis. - SASI says the goal is to improve trial planning, execution and oversight through measurable operational intelligence. - TrialSite Inc. says its broader mission is to increase transparency, awareness and engagement across global clinical development.

The bottom line: - The SASI benchmark reframes clinical-trial performance as an execution problem as much as a science problem, with disclosure failures emerging as the biggest exposure in the dataset.