Clinical Trial Optimization for Hidradenitis Suppurativa
Clinical trial design increasingly depends on the ability to extract actionable insights from historical data, especially in complex inflammatory diseases such as hidradenitis suppurativa (HS).This case study explores how a global pharmaceutical company used AI to identify predictive patient characteristics and optimize enrollment criteria for future dermatology trials.
Nextigent AI implemented a Trial Optimization Intelligence Platform to analyze historical HS trial data and generate predictive enrollment recommendations.
Predictive trial success probability increased by 40%+
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Trial planning time reduced from months to weeks
Project Scope
The project covered data aggregation, AI model training, predictive analysis, and deployment of interactive planning dashboards.The platform was designed to support continuous scenario modeling for future studies and integrate with the client’s existing trial planning infrastructure.
Tech Stack
Python
Scikit-learn
Vertex AI
Spotfire
Data sources
ClinicalTrials.gov
Pharmaproject
PubMed
Internal Trial Data
The Client
The client is a global pharmaceutical company managing multiple dermatology clinical programs.Their goal was to improve the design and success rate of hidradenitis suppurativa trials by identifying baseline patient variables most strongly associated with positive outcomes.
Business Requirements
Improve probability of clinical trial success
Reduce time required for trial planning and enrollment design
Identify predictive baseline variables using historical trial data
Enable data-driven inclusion and exclusion criteria selection
Support scalable use across future immunology and dermatology studies
The Problem
Clinical outcomes across HS studies showed significant variability.Research teams lacked a structured way to determine which patient characteristics correlated with treatment efficacy, making trial design heavily dependent on manual review and expert interpretation.
The Challenges
Aggregating heterogeneous clinical and research datasets
Identifying subtle correlations within complex patient variables
Building interpretable predictive models for clinical teams
Ensuring secure handling of sensitive sponsor trial data
Problems Revealed
During implementation, it became clear that valuable predictive signals existed across historical datasets but were not systematically analyzed.Traditional statistical review methods were unable to efficiently evaluate multidimensional interactions between patient characteristics and outcomes.
The Solution
Nextigent AI deployed the Trial Optimization Intelligence Platform to analyze baseline and outcome data from previous HS studies.Machine learning models were used for feature selection, predictive scoring, and scenario simulation. The system identified which patient variables most strongly correlated with successful endpoints and generated recommendations for inclusion and exclusion criteria.Interactive dashboards enabled researchers to visualize correlations, compare trial scenarios, and model future study outcomes in real time.The platform was deployed within a secure cloud environment integrated with the client’s clinical planning tools.
Achievements
Identified 4 key baseline variables associated with positive outcomes
Increased predictive trial success probability by over 40%
Reduced trial planning time from months to weeks
Improved confidence in enrollment strategy decisions
The platform transformed trial planning into a structured, AI-assisted process driven by predictive analytics rather than manual, retrospective review.
Future Plans
The client plans to expand the platform into additional inflammatory and immunology indications.Future enhancements include adaptive trial simulations and integration with real-world evidence datasets.