DDM

DDM™ (Dynamic Data Monitoring) is a patented breakthrough platform developed by CIMS Global for the dynamic monitoring and optimization of clinical trials. Designed for use by Independent Data Monitoring Committees (IDMCs) and clinical trial teams, DDM displays the cumulative treatment effect on a "trial radar" screen and predicts a clinical trial's chance of success or failure in real time.

DDM can be integrated with any Electronic Data Capture (EDC) system to monitor ongoing trials, deployed as a standalone tool, or used retrospectively for trial "diagnosis." By enabling continuous monitoring and adaptive decision-making, DDM can greatly improve the chance of success for promising trials and save organizations millions of dollars through early detection of futile studies.

Core Platform Capabilities

• Generates a trial "radar screen" divided into four regions — favorable, hopeful, unfavorable, and futile — based on study design parameters
• Automatically computes cumulative treatment effect for chosen safety or efficacy endpoints as the trial progresses
• Displays treatment effect over information time (the proportion of subjects who have reached the endpoint) on the radar screen
• Enables the IDMC to visualize trial status and make evidence-based recommendations on trial optimization
• Supports sample size re-estimation, early termination decisions, and drug safety alerts
• Allows prediction of trial success or failure through trend analysis or simulation

Key Benefits

• Real-Time Insights: DDM automatically updates key metrics as new data accumulates, providing real-time visualization and trend analysis of the trial
• Outcome Prediction: Provides foresight into whether a trial is trending toward success or failure, enabling informed decisions about continuation or early termination of a hopeless trial
• Population Enrichment: Identifies the most beneficial subpopulation within a study to optimize recruitment strategy
• Trial Diagnosis: Reconstructs unsuccessful trials to understand what went wrong and extract lessons for future studies
• Real-World Evidence (RWE) Monitoring: Monitors drug safety and treatment evidence in real-world settings
• Hypotheses Checking and Model Diagnosis: Validates design hypotheses such as assumed treatment effect and the validity of model assumptions

Adaptive Sequential Design in Practice

• Supports Adaptive Sequential Design workflows, including interim looks at defined points of patient accrual (e.g., 30% and 75%)
• Enables sample size re-estimation at interim analysis points based on accumulating data
• Allows trial boundaries to be updated dynamically, supporting adaptive decision-making throughout the trial lifecycle
• Demonstrates how continuous monitoring and adaptation can lead to trial success even when initial parameters require adjustment

DDM is built to integrate seamlessly with existing EDC systems, making it suitable for a wide range of clinical trial environments. Its novel Dynamic Data Monitoring technology empowers sponsors, CROs, and IDMCs to make confident, data-backed decisions at every stage of a clinical trial.