New 2026 Trends
Reducing Avoidable Protocol Amendments by Anticipating Operational Pitfalls Hidden in Clinical Trial Design
Our investigation into our operational dataset of more than 30,000 studies and 70,000 amendments revealed where amendments occurred the most, what drove each amendment, and distinct patterns for amendments across therapeutic areas.
Across six distinct areas of research, we identified major amendment drivers that can help you predict and avoid unnecessary amendments.
Study Design, powered by AI and data from Advarra’s IRB and clinical trial systems
AI-driven study design can identify avoidable amendments before a clinical trial begins.
In a Phase III, oncology trial, 55% of amendments were identified as partially avoidable, driven by complexity in endpoints, eligibility criteria, and schedule of assessments.
In a Phase II, Alzheimer’s trial, 60% of amendments were identified as preventable, driven by higher-than-average inclusion and exclusion criteria.
In a Phase II, ALS trial, 63% of amendments were identified as avoidable, driven by cumulative eligibility complexity and elevated assessment intensity.
Start a discussion with our study design experts to leverage IRB operational insights to mitigate downstream hurdles before your study starts.
Advarra’s Study Design Solution Named “Best Clinical Study Design Solution” in 2026 MedTech Breakthrough Awards Program
MedTech Breakthrough awarded Advarra’s Study Design solution for unlocking previously trapped insights from stagnant documents and demonstrating the real-world impact of more intelligent, resilient trial design.
Simplify trial designs to improve operational efficiency in clinical trials
Clinical trial protocol optimization processes are often done with incomplete data, using in-house studies or public datasets. This leaves researchers without robust comparative intelligence to improve trial designs and downstream operational efficiency.
Advarra’s Study Design solution provides insights on design factors that drive operational feasibility, such as the impact of eligibility criteria, site and participant burden from the schedule of assessments, and reasons for amendments. These insights enable sponsors to better anticipate downstream operational challenges, make informed decisions on how to simplify trial designs, and accelerate protocol development timelines.
Process improvement
Accelerate the study design process with fewer and smoother iterations.
Simpler designs
Minimize study operational complexity to accelerate trial timelines.
Competitive edge
Ground protocol design decisions in unmatched operational intelligence for a competitive edge.
Study Design is powered by Braid™, Advarra’s data and AI engine
Braid includes a uniquely rich and comprehensive set of operational data drawn from Advarra’s institutional review board (IRB) and clinical trial systems, encompassing over 170,000 protocol-related documents and operations data from 30,000 studies across over 3,500 sponsors.
Braid transforms unstructured data into actionable intelligence—enabling smarter trial design, faster decisions, and streamlined execution across the clinical trial lifecycle.
Discover the power of trial operations data
Featured content
Press release
Advarra Launches AI- and Data-Backed Study Design Solution to Improve Operational Efficiency in Clinical Trials
Read the full announcement to learn more about the launch of Advarra’s Study Design solution.
Video clip
Weaving Intelligence into Clinical Trials
Explore how data, AI, and simulation can transform the way trials are designed—reducing amendments, improving efficiency, and aligning study planning with operational realities.
Blog
Advarra’s Perspective on FDA’s Draft AI Guidance: Advancing Responsible Innovation
Advarra’s Laura Russell, SVP and head of data and AI product development, shares Advarra’s perspective on the FDA’s recent AI guidance—grounded in scientific rigor and implementation experience—highlighting five key areas for potential evolution.
On-demand Webinar
Embedding AI and Critical IRB Operations Data to Drive Intelligent Study Design
This presentation offers a clear roadmap for navigating the evolving complexities of the industry. Modern clinical trial design is being transformed by a rich array of data sources, from digitized protocols and literature to real-world insights.