DDM is a patented breakthrough platform which displays the cumulative treatment effect on a “trial radar” screen and predicts a clinical trial’s chance of success or failure.

With DDM, the IDMC can visualize trial status and make recommendations on trial optimization, sample size re-estimation, early termination, and drug safety alerts. DDM can be integrated with any EDC system to monitor ongoing trials, used as a standalone tool, or used for trial “diagnosis”. DDM can greatly improve the chance of success for a promising trial and save companies millions of dollars with early detection of a hopeless study.

Based on study design parameters, the DDM system can create a trial “radar screen” that will be divided into four regions: favorable, hopeful, unfavorable, and futile. As the trial progresses, the system automatically computes the cumulative treatment effect for chosen endpoints (safety or efficacy) and displays it over the information time (proportion of subjects that have reached the endpoint) on the radar screen. This effect can be viewed by the IDM and its potential success or failure can be predicted by trend analysis or simulation.

The video displays a trial based on Adaptive Sequential Design with an initial sample size of 100 per arm and the interim looks at 30% and 75% of patient accrual. Sample size re-estimation was performed at 75% patient accrual to have 227 per arm. The trial crossed the updated boundary at 180 patients. This trial eventually becomes successful with “continuous” monitoring and adaptation.

With DDM, you can effectively monitor your trials.

DDM automatically updates key metrics as new data accumulates, providing real-time visualization and trend the trial. 

DDM gives you foresight into whether your trial is trending toward success or failure, allowing you to decide whether to continue with your progress or terminate a hopeless trial.

DDM can be used to identify the most beneficial subpopulation in your study so you can optimize the recruitment strategy.

DDM can be used to re-construct an unsuccessful trial to understand what went wrong and learn lessons in preparation for future studies.

DDM can be used to monitor drug safety and treatment evidence in real-world setting.

DDM can be used to check the design hypotheses such as assumed treatment effect or the validity of a model assumption.   

Gain trusted insight into your data and confidently make decisions backed by our novel Dynamic Data Monitoring technology.

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