CIMS Global CEO Dr. Tai Xie presented the concept of DDM – Dynamic Data Monitoring – at the JSM conference in Denver, Colorado on July 27, 2019.
DDM is an innovative design that combines Dynamic Adaptive Design (DAD) with a data-guided analysis for timing the SSR. The DDM process covers:
- Continuously monitoring on-going data
- Data-guided adaptation
- Using the trend analysis to detect whether the trial is “promising” or “hopeless”
- Controlling the Type I error rate
- Furnishing inference for final analysis
DDM Use Cases
CIMS Global has developed a Dynamic Adaptive Design and DDM ecosystem that has the potential to dramatically change the way that clinical trials are conducted.
DDM improves upon both Group Sequential Design (GSD) and Adaptive Sequential Design (ASD) because it is more efficient than ASD and has broader applications:
- Sample size re-estimation
- Trial optimization
- Early termination of “hopeless” trials
- Projection of “promising” trials
- Drug safety signal detection
- Dose/therapy selection
- Population selection and enrichment
- Real World Evidence studies
Here is an example of applying DDM to a real study that was successful. This was a multi-center, randomized, double-blind, placebo-control phase II study with an oral drug treating older patients with nocturia.
Here is an example of applying DDM to a real study that failed. This was a randomized, double-blind, placebo-controlled, exploratory phase IIa study to assess the safety and efficacy of oral drug in NAFLD patients. N=96 and the study took 2 years to finish.
JSM DDM Presentation Deck
Here is Dr. Xie’s presentation deck for download.
About CIMS Global
CIMS is pioneering the DTD and DDM categories with a vision of reshaping the future of clinical trials. With our proprietary closed system, we’re empowering pharmaceutical and biotech companies to bring drugs to market sooner, saving millions of dollars on clinical trials and bringing much-needed therapies to patients faster.
Contact CIMS Global to learn more.