New AI-powered tool streamlines trial feasibility and re-forecasting from start to finish
Spectrum supports study teams by providing real-time predictions and control over trial timelines and costs, ensuring successful trials in today's complex landscape.
Clinical trials today are more intricate than ever. Late-phase studies now collect over 3.5 million data points, triple the amount from a decade ago, and must juggle an average of 26 endpoints, including specific biomarkers. These challenges contribute to longer trial timelines, with patient recruitment for phase 3 trials averaging 18 months—a 39% increase from 2008 to 2019. Moreover, trials often undergo mid-study protocol amendments, which have risen by 60% since 2015, according to a Tufts Center study.
Spectrum can empower study teams with robust strategic and operational feasibility analysis from the start of a trial and allows for mid-study adjustments. It integrates ongoing financial forecasting, dynamically adjusting budgets in real-time based on actual data rather than assumptions.
AI clinical trial feasibility
One contract research organization (CRO) used Spectrum to swiftly plan a sponsor bid defense, offering multiple scenarios and recommendations that optimized time, cost, and country mix.
Spectrum also leverages causal AI (a form of artificial intelligence designed to identify and understand the cause and effect of relationships across data) to provide real-time recommendations, enabling proactive intervention to keep trials on track. This feature is especially beneficial given current staffing challenges in the industry, offering reliable, data-driven guidance to junior staff.
Key features of Spectrum include an easy-to-understand site startup sequencing and modeling, AI/ML algorithms help map the most efficient order and timing for site activations, and reducing delays and enhancing trial efficiency.
Trial optimization
It includes high throughput scenario planning and optimization and can rapidly evaluate hundreds of scenarios to determine optimal trial outcomes.
Another feature includes accurate study enrollment projections incorporating factors like site fatigue for superior enrollment forecasting. Lokavant says it can produce financial and budget forecasting and has powerful tools for accurate cost projections, budget planning, and financial management throughout the trial lifecycle.
By offering data-driven recommendations the company says the software offers clear, actionable guidance at every stage of the trial with real-time impact forecasting. It also has the ability to generate detailed reports and export data in various formats for effective stakeholder communication and thorough trial analysis.
Real-time predictions
“In minutes, Spectrum can run thousands of simulations to uncover the best recommendations based on customer priorities – and all in real-time for continuous remediation,” explained Aaron Mackey, senior vice president of AI and data science at Lokavant.
“Spectrum’s capabilities for trial planning optimization leaves no stone unturned to provide accurate insights in half the time.”
Lokavant’s platform, enriched with data from over 2,000 studies and more than 400,000 third-party trials, provides sponsors and CROs with precise real-time trial performance and feasibility assessments, optimizing decision-making. The platform has already demonstrated a 70x improvement in enrollment forecast accuracy, over $1 million in cost savings from patient retention, and six months saved from detecting site noncompliance issues.
Scenario planning and optimization
“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,” said Rohit Nambisan, CEO, and co-founder of Lokavant. “Spectrum empowers teams to optimize research and manage costs, facilitating the swift delivery of the right therapies to the right patients.”
Lokavant’s new Spectrum feasibility solution will be at the Drug Information Association (DIA)’s 60th annual meeting from June 16-20 in San Diego. Lokavant will present it on June 18 at 9:15 am in Innovation Theater number 217.
