DDM

DDM is a patented platform designed to enhance the management and success of clinical trials. It provides a 'trial radar' screen that displays the cumulative treatment effect, allowing for the prediction of a trial's success or failure.

Dynamically Monitor and Optimize Your Clinical Trial

DDM enables the Independent Data Monitoring Committee (IDMC) to visualize trial status and make informed recommendations on trial optimization, sample size re-estimation, early termination, and drug safety alerts. It can be integrated with any Electronic Data Capture (EDC) system or used independently for trial diagnosis. This capability can significantly increase the likelihood of a trial's success and save resources by identifying unpromising studies early.

Track Your Trial Progress Through the Radar Screen

The system creates a trial 'radar screen' divided into four regions: favorable, hopeful, unfavorable, and futile. As the trial progresses, it computes the cumulative treatment effect for selected endpoints, such as safety or efficacy, and displays this over the information time, which is the proportion of subjects that have reached the endpoint. This visualization allows the IDMC to predict potential success or failure through trend analysis or simulation.

DDM Leading to Clinical Trial Success

DDM supports trials using Adaptive Sequential Design, allowing for continuous monitoring and adaptation. For example, a trial with an initial sample size of 100 per arm, with interim looks at 30% and 75% of patient accrual, can have its sample size re-estimated to 227 per arm at 75% accrual. This approach helps in crossing updated boundaries effectively, as demonstrated in a trial that became successful with continuous monitoring.

Key Benefits

• Run Your Clinical Trial with Efficiency: DDM offers effective monitoring capabilities.
• Real-time Insights: It updates key metrics automatically as new data accumulates, providing real-time visualization and trend analysis.
• Predict the Outcome of Your Trial: DDM provides foresight into trial trends, helping decide whether to continue or terminate a trial.
• Population Enrichment: Identifies beneficial subpopulations to optimize recruitment strategies.
• Trial Diagnosis: Reconstructs unsuccessful trials to understand failures and prepare for future studies.
• RWE Monitoring: Monitors drug safety and treatment evidence in real-world settings.
• Hypotheses Checking and Model Diagnosis: Checks design hypotheses and model assumptions.

DDM offers trusted insights into trial data, enabling confident decision-making backed by its Dynamic Data Monitoring technology.