June 11, 2024, 8:47 AM EDT
New solution supports trial feasibility prediction, optimization, and control throughout the trial
NEW YORK – June 11, 2024 – Lokavant, the clinical trial intelligence platform company, today announced Spectrum™, the first AI clinical trial feasibility software solution for trial optimization across the entire clinical development value chain. Spectrum allows study teams to predict, optimize, and control trial timelines and costs in real-time, enabling iterative feasibility analysis and mid-study course correction – critical to success in today’s hyper-complex trial environment.
Modern clinical trials are complex. More than 3.5 million data points are collected per late-phase study, triple the number from a decade ago. These datasets include a growing number of primary and secondary endpoints – now averaging 26 for late-phase trials – as well as specific biomarkers. An evolving regulatory landscape adds more challenges. All of this complexity contributes to longer trial timelines: it takes an average of eighteen months to recruit patients for a phase III trial, a 39% jump from 2008 to 2019. Additionally, clinical trials must absorb mid-study protocol amendments – which, per trial, have increased from 2.1 to 3.3 since 2015 (a 60% rise), according to a 2022 study by Tufts Center for the Study of Drug Development.
Lokavant’s Spectrum solution enables study teams to conduct more accurate strategic and operational feasibility analysis at the start of a clinical trial, as well as mid-study assessments, powering a continual cycle of analysis, re-forecasting, and optimization. The solution also automatically incorporates ongoing financial forecasting without time-consuming manual intervention to accurately model budgets. With Spectrum, timeline changes dynamically drive commensurate changes in budgets – providing more granular modeling using real data, not just assumptions.
One contract research organization (CRO) used Spectrum to rapidly respond and plan for sponsor bid defense, evaluating multiple scenarios and providing several recommendations to the sponsor that optimized time, cost, and country mix.
Spectrum can also incorporate “causal AI,” a prescriptive form of artificial intelligence that offers recommendations in real-time so study teams can take proactive remedial action before a trial veers off course. These recommendations also provide reliable, data-driven guidance to junior study staff, a key advantage, especially amidst current industry-wide staffing challenges.
Key Spectrum functionality includes the following:
Comprehensive site startup sequencing and modeling – Utilizing AI/ML algorithms and leveraging regulatory approval, startup, and enrollment data, Spectrum enables clinical trial teams to map out the most efficient order and timing for activating trial sites, minimize delays, and enhance overall trial efficiency.
- High throughput scenario planning and optimization – By rapidly generating and evaluating hundreds of scenarios for potential impacts on timelines, costs, and resources, Spectrum evaluates all scenarios for an optimal trial outcome.
- Accurate study enrollment projections – Spectrum’s models incorporate site fatigue and other granular factors to offer best-in-class enrollment forecasting.
- Reliable financial and budget forecasting – With Spectrum's powerful financial and budget forecasting tools, study teams can project costs accurately, plan budgets effectively, and manage financial resources throughout the trial lifecycle, ensuring fiscal responsibility and transparency.
- Data-driven recommendations – Spectrum provides clear, data-driven recommendations for the next best course of action at every stage of the trial. Click to forecast the impact of proposed recommendations on trial timelines and costs.
- Easy, automated reporting and exports – Spectrum offers extensive reporting and export capabilities, allowing study teams to generate detailed reports and export data in various formats. These features support effective communication with stakeholders and facilitate thorough analysis and documentation of trial progress.
“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, PhD, senior vice president of AI and data science at Lokavant. “Spectrum’s capabilities for trial planning optimization leave no stone unturned to provide accurate insights in half the time.”
Lokavant’s Clinical Intelligence Platform and predictive analytics applications are built with proprietary historical trial data from more than 2,000 studies involving more than 14,000 investigators, 12,000 healthcare institutions, real-world data (RWD) sources, and more than 400,000 third-party trials. The platform enables sponsors and CROs to accurately see real-time trial performance and feasibility assessments to optimize decision-making. It has already proven a 70x improvement in enrollment forecast accuracy, over $1 million in cost savings from patient retention, and six months' time savings from 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,” 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.”
Learn more about Lokavant’s new Spectrum feasibility solution at the Drug Information Association’s 60th Annual Meeting ( June 16-20 ) in San Diego, where Lokavant will be presenting its solution on June 18 at 9:15 am in Innovation Theater #3.