Abstract: This invention relates to a method and process which dynamically monitors data from an on-going randomized clinical trial associated with a drug, device, or treatment. In one embodiment, the present invention automatically and continuously unblinds the study data without human involvement. In one embodiment, a complete trace of statistical parameters such as treatment effect, trend ratio, maximum trend ratio, mean trend ratio, minimum sample size ratio, confidence interval and conditional power are calculated continuously at all points along the information time. In one embodiment, the invention discloses a graphical user interface-based method and system to early conclude a decision, i.e., futile, promising, sample size re-estimate, for an on-going clinical trial. In one embodiment, exact type I error rate control, median unbiased estimate of treatment effect, and exact two-sided confidence interval can be continuously calculated.

Abstract: The present invention constructs a “radar” system for dynamically monitoring and guiding ongoing clinical trials. In one embodiment, the system partitions the data space into 3 primary regions comprising “favorable”, “hopeful” and “undesirable” to reflect the trial status. In one embodiment, the undesirable region comprises a futility region, and the favorable region comprises a successful region. In one embodiment, the boundaries defining these regions are subject to adjustment as the clinical trial proceeds. In one embodiment, the accumulative treatment effect, data trends, stopping boundaries, trajectory and other information are graphically displayed on the “radar” screen. In one embodiment, the system takes learning from the observed and accumulated data and performs simulations to intelligently guide the trials. In one embodiment, the system is used in re-analysis or diagnosis of clinical trials already completed and provides guidance for clinical trial design or amendment.

Abstract: This invention relates to a method and process which dynamically monitors data from an on-going randomized clinical trial associated with a drug, device, or treatment. In one embodiment, the present invention automatically and continuously unblinds the study data without human involvement. In one embodiment, a complete trace of statistical parameters such as treatment effect, trend ratio, maximum trend ratio, mean trend ratio, minimum sample size ratio, confidence interval and conditional power are calculated continuously at all points along the information time. In one embodiment, the invention discloses a graphical user interface-based method and system to early conclude a decision, i.e., futile, promising, sample size re-estimate, for an on-going clinical trial. In one embodiment, exact type I error rate control, median unbiased estimate of treatment effect, and exact two-sided confidence interval can be continuously calculated.