System and method for continuous data analysis of an ongoing clinical trial
First Claim
1. A computer readable storage medium comprising computer executable instructions for continuously analyzing trial data of an ongoing clinical trial that, when executed by a processor, cause the processer to:
- access a trial database comprising trial data of subjects in a blinded ongoing clinical trial comprising a multi-arm study while maintaining blindness of said blinded ongoing clinical trial;
access a blinding database comprising subject identifiers and associated study group identifiers, wherein a subject'"'"'s study group being identifiable by a study group identifier;
generate a grouped database from said trial database and said blinding database for statistical analysis, said grouped database grouping said trial data of said subjects based on their study group;
perform near real-time statistical analysis on said trial data to determine a parameter of statistical term of interest without suspending and while maintaining the blindness of said blinded ongoing clinical trial;
determine whether said parameter of statistical term of interest exceeds a threshold value and a difference in said parameter of statistical term of interest among said multi-arm study;
andrepeat the computer executable instructions for accessing said trial database, performing and determining during said blinded ongoing clinical trial and while maintaining the blindness of said blinded ongoing clinical trial until it is determined that said parameter of statistical term of interest exceeds said threshold value.
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0 Petitions
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
41 Claims
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1. A computer readable storage medium comprising computer executable instructions for continuously analyzing trial data of an ongoing clinical trial that, when executed by a processor, cause the processer to:
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access a trial database comprising trial data of subjects in a blinded ongoing clinical trial comprising a multi-arm study while maintaining blindness of said blinded ongoing clinical trial; access a blinding database comprising subject identifiers and associated study group identifiers, wherein a subject'"'"'s study group being identifiable by a study group identifier; generate a grouped database from said trial database and said blinding database for statistical analysis, said grouped database grouping said trial data of said subjects based on their study group; perform near real-time statistical analysis on said trial data to determine a parameter of statistical term of interest without suspending and while maintaining the blindness of said blinded ongoing clinical trial; determine whether said parameter of statistical term of interest exceeds a threshold value and a difference in said parameter of statistical term of interest among said multi-arm study; and repeat the computer executable instructions for accessing said trial database, performing and determining during said blinded ongoing clinical trial and while maintaining the blindness of said blinded ongoing clinical trial until it is determined that said parameter of statistical term of interest exceeds said threshold value. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 40)
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20. A system for continuously analyzing trial data of an ongoing clinical trial, comprising:
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a trial database comprising trial data of subjects in said ongoing clinical trial comprising a multi-arm study; a blinding database comprising subject identifiers and associated study group identifiers, wherein a subject'"'"'s study group being identifiable by a study group identifier; and a processor for; accessing said trial database to retrieve said trial data while maintaining blindness of said blinded ongoing clinical trial; accessing said blinded database to retrieve said subject identifiers and associated study group identifiers; generating a grouped database from said trial database and said blinded database for statistical analysis, said grouped database grouping said trial data of said subjects based on their study group; performing near real-time statistical analysis on said trial data to determine a parameter of statistical term of interest without suspending said ongoing clinical trial; and determining whether the result of said statistical analysis exceeds a threshold value; wherein said processor is operable to repeatedly access, perform and determine during said ongoing clinical trial until it is determined that the result of said statistical analysis exceeds said threshold value. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 41)
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Specification