System and method for continuous data analysis of an ongoing clinical trial

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.

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.   
     
     
         2 . The computer readable storage medium of  claim 1 , further comprising instructions that, when executed by the processor cause the processor to iteratively calculate and determine based on whether the statistically significant event has occurred. 
     
     
         3 . The computer readable storage medium of  claim 1 , further comprising instructions that, when executed by the processor, cause the processor to retrieve the trial data for an ongoing clinical trial from a plurality of records maintained in at least one data storage device. 
     
     
         4 . The computer readable storage medium of  claim 3 , further comprising instructions that, when executed by the processor cause the processor to retrieve the plurality of records having a predetermined level of cleanliness that satisfies a user defined cleanliness criteria. 
     
     
         5 . The computer readable storage medium of  claim 3 , wherein the plurality of records include at least two of a subject identifier, an arm identifier, a value associated with said parameter, and a cleanliness value. 
     
     
         6 . The computer readable storage medium of  claim 3 , further comprising computer executable instructions that, when executed by a processor, cause the processer to
 unblind the retrieved trial data; and   group the retrieved trial data into a plurality of arms.   
     
     
         7 . The computer readable storage medium of  claim 6 , wherein said determined statistical term of interest is determined by comparing a first parameter of a first arm to a second parameter of a second arm of the ongoing clinical trial. 
     
     
         8 . The computer readable storage medium of  claim 1 , wherein said statistically significant event represents one of efficacy of the ongoing clinical trial, safety of the ongoing clinical trial, and level of participation in said at least one arm of the ongoing clinical trial. 
     
     
         9 . The computer readable storage medium of  claim 1 , wherein instructions to determine further cause the processor to determine a rate of change in said determined statistical term of interest between at least two time intervals during the ongoing clinical trial. 
     
     
         10 . The computer readable storage medium of  claim 1 , further comprising instructions that, when executed by the processor cause the processor to generate an alert based on the determination that said statistically significant event has occurred during the ongoing clinical trial. 
     
     
         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. 
   
     
     
         12 . The system of  claim 11 , wherein the system is further configured to iteratively calculate and determine based on whether the statistically significant event has occurred. 
     
     
         13 . The system of  claim 11 , wherein the processor is further configured to retrieve the trial data for an ongoing clinical trial from a plurality of records maintained in at least one storage device. 
     
     
         14 . The system of  claim 13 , wherein the processor is further configured to retrieve the plurality of records having a predetermined level of cleanliness that satisfies a user defined cleanliness criteria. 
     
     
         15 . The system of  claim 13 , wherein the plurality of records include at least two of a subject identifier, an arm identifier, a value associated with said parameter, and a cleanliness value. 
     
     
         16 . The system of  claim 13 , wherein the processer is further configured to
 unblind the retrieved trial data; and   group the retrieved trial data into a plurality of arms.   
     
     
         17 . The system of  claim 16 , wherein said determined statistical term of interest is determined by comparing a first parameter of a first arm to a second parameter of a second arm of the ongoing clinical trial. 
     
     
         18 . The system of  claim 11 , wherein said statistically significant event represents one of efficacy of the ongoing clinical trial, safety of the ongoing clinical trial, and level of participation in said at least one arm of the ongoing clinical trial. 
     
     
         19 . The system of  claim 11 , wherein the processor is further configured to determine a rate of change in said determined statistical term of interest between at least two time intervals during the ongoing clinical trial. 
     
     
         20 . The system of  claim 11 , wherein further the processor is further configured to generate an alert based on the determination that said statistically significant event has occurred during the ongoing clinical trial. 
     
     
         21 . A method comprising:
 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.   
     
     
         22 . The method of  claim 21 , further comprising iteratively calculating and determining based on whether the statistically significant event has occurred. 
     
     
         23 . The method of  claim 21 , further comprising retrieving the trial data of the ongoing clinical trial from trial records maintained in at least one data storage device. 
     
     
         24 . The method of  claim 23 , wherein retrieving the trial data includes retrieving a portion of the trial records having a level of cleanliness that satisfies a predetermined criterion. 
     
     
         25 . The method of  claim 23 , wherein a trial record includes at least two of a subject identifier, an arm identifier, a parameter value, and a cleanliness value. 
     
     
         26 . The method of  claim 21 , further comprising:
 unblinding the trial data; and   grouping the unblinded trial data into a plurality of arms.   
     
     
         27 . The method of  claim 26 , wherein said determining the statically term of interest includes comparing a first parameter of a first arm to a second parameter of a second arm of the ongoing clinical trial. 
     
     
         28 . The method of  claim 21 , wherein said statistically significant event represents one of efficacy of the ongoing clinical trial, safety of the ongoing clinical trial, and level of participation in said at least one arm of the ongoing clinical trial. 
     
     
         29 . The method of  claim 21 , further comprising determining a rate of change in said determined statistical term of interest between at least two time intervals during the ongoing clinical trial. 
     
     
         30 . The method of  claim 21 , further comprising generating an alert based on the determination that said statistically significant event has occurred during the ongoing clinical trial.