Lokavant Introduces AI Solution for Comprehensive Clinical Trial Optimization

Lokavant has unveiled Spectrum, an AI software solution designed to enhance clinical trial feasibility and optimization throughout the entire clinical development process. This platform enables study teams to predict, manage, and adjust trial timelines and budgets in real-time, providing iterative feasibility analysis and mid-study course corrections essential for today’s intricate trial environments.

Modern clinical trials are increasingly complex, accumulating over 3.5 million data points in late-phase studies—three times more than a decade ago. These studies now average 26 endpoints and include various biomarkers. Regulatory changes add further complications, extending patient recruitment for phase III trials by 39% from 2008 to 2019, with recruitment taking an average of eighteen months. Furthermore, mid-study protocol amendments have risen by 60% since 2015, increasing from 2.1 to 3.3 amendments per trial, as reported by the Tufts Center for the Study of Drug Development in 2022.

Anticipated enrollment; Image credit: Lokavant

Key Features and Functionality of Spectrum

Lokavant’s Spectrum provides several key functionalities to address these challenges:

• Comprehensive Site Startup Sequencing and Modeling: Utilizing AI and machine learning algorithms, Spectrum maps out the optimal order and timing for trial site activation, leveraging regulatory approval, startup, and enrollment data to minimize delays and enhance efficiency.

• High Throughput Scenario Planning and Optimization: The platform generates and evaluates hundreds of scenarios, assessing potential impacts on timelines, costs, and resources to determine the optimal trial outcome.

• Accurate Study Enrollment Projections: Spectrum incorporates factors such as site fatigue to deliver precise enrollment forecasts.

• Reliable Financial and Budget Forecasting: The solution dynamically integrates financial forecasting, aligning budget models with real data to accurately project costs and manage financial resources throughout the trial lifecycle.

• Data-Driven Recommendations: Spectrum provides actionable, data-driven guidance for each stage of the trial, allowing study teams to forecast the impact of proposed actions on trial timelines and costs.

• Automated Reporting and Exports: The platform supports extensive reporting and export capabilities, facilitating effective communication with stakeholders and thorough analysis of trial progress.

Spectrum’s ability to run thousands of simulations in minutes enables real-time recommendations and continuous remediation, as noted by Aaron Mackey, PhD, Lokavant’s senior vice president of AI and data science. This ensures comprehensive trial optimization and precise insights.

See also: Better Data Management is Key for Clinical Trials: Interview with Raj Indupuri, CEO, eClinical Solutions

Impact and Industry Significance

Lokavant’s Clinical Intelligence Platform, built on data from over 2,000 studies, 14,000 investigators, 12,000 healthcare institutions, real-world data sources, and more than 400,000 third-party trials, offers sponsors and CROs a detailed view of trial performance. The platform has demonstrated significant improvements, including a 70-fold increase in enrollment forecast accuracy, over $1 million in cost savings from patient retention, and six months’ savings by detecting site noncompliance issues.

“The industry needs novel approaches to clinical trial operations that match the innovation in clinical sciences, especially as trials grow increasingly complex, personalized, and specialized. […] Spectrum empowers teams to optimize research and manage costs, facilitating the swift delivery of the right therapies to the right patients,” said Rohit Nambisan, CEO and co-founder of Lokavant.