SYSTEM AND METHOD FOR CONTINUOUS DATA ANALYSIS OF AN ONGOING CLINICAL TRIAL
First Claim
1. A computer readable storage medium comprising computer executable instructions that, when executed by a processor, cause the processer to:
- calculate, during at least one time interval of an ongoing clinical trial, a statistical term of interest associated with a parameter in trial data of at least one arm of the ongoing clinical trial; and
determine, in near-real time, whether the calculated statistical term of interest at the at least one time interval indicates the occurrence of a statistically significant event in the ongoing clinical trial.
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Accused Products
Abstract
System and method of continuously analyzing trial data of an ongoing clinical trial is provided. A statistical analysis is performed on a trial database containing subject trial data without suspending the ongoing clinical trial. If the result of the statistical analysis does not exceed a predetermined threshold value, then the statistical analysis is repeated while the clinical trial is ongoing. In a blinded clinical trial, a grouped database is generated from the trial database and a blinding database prior to performing the statistical analysis. The grouped database groups the subject trial data according to the study groups. The ability to continuously monitor and analyze the trial data for statistical significance in tandem with data collection while the trial is ongoing provides many benefits to the researchers because the trial database no longer becomes the bottleneck in obtaining useful results and statistical analysis can be conducted on a near real-time basis without having to wait until completion of the trial.
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Citations
30 Claims
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1. A computer readable storage medium comprising computer executable instructions that, when executed by a processor, cause the processer to:
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calculate, during at least one time interval of an ongoing clinical trial, a statistical term of interest associated with a parameter in trial data of at least one arm of the ongoing clinical trial; and determine, in near-real time, whether the calculated statistical term of interest at the at least one time interval indicates the occurrence of a statistically significant event in the ongoing clinical trial. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A system to analyze trial data of a multi-arm study in an ongoing clinical trial, comprising:
a processing device configured to; calculate, during at least one time interval of the ongoing clinical trial, a statistical term of interest associated with a parameter in trial data of at least one arm of the ongoing clinical trial; and determine, in near-real time, whether the calculated statistical term of interest at the at least one time interval indicates the occurrence of a statistically significant event in the ongoing clinical trial. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18, 19, 20)
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21. A method comprising:
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calculating in a computing device, during at least one time interval of the ongoing clinical trial, a statistical term of interest associated with a parameter in trial data of at least one arm of the ongoing clinical trial; and determining in the computing device, in near-real time, whether the calculated statistical term of interest during the at least one time interval indicates the occurrence of a statistically significant event in the ongoing clinical trial. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28, 29, 30)
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Specification