System and method for continuous data analysis of an ongoing clinical trial
First Claim
1. A method of continuously analyzing trial data of an ongoing clinical trial, the method comprising:
- accessing a trial database containing trial data of subjects in a clinical trial;
performing a statistical analysis on the accessed trial database;
determining whether the result of the statistical analysis exceeds a predetermined threshold value; and
if it is determined that the result of the statistical analysis does not exceed the predetermined threshold value, then repeating the steps of accessing, performing and determining while the clinical trial is ongoing.
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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. 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.
83 Citations
24 Claims
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1. A method of continuously analyzing trial data of an ongoing clinical trial, the method comprising:
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accessing a trial database containing trial data of subjects in a clinical trial;
performing a statistical analysis on the accessed trial database;
determining whether the result of the statistical analysis exceeds a predetermined threshold value; and
if it is determined that the result of the statistical analysis does not exceed the predetermined threshold value, then repeating the steps of accessing, performing and determining while the clinical trial is ongoing. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A method of continuously analyzing trial data of an ongoing blinded clinical trial, the method comprising:
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accessing a trial database containing blinded trial data of subjects in an ongoing blinded clinical trial;
accessing a blinding database containing subject identifiers and associated study group identifiers, each study group identifier identifying to which study group an associated subject belongs;
producing a grouped database from the trial database and the blinding database, the grouped database grouping the trial data according to the study group;
performing a statistical analysis on the produced grouped database;
determining whether the result of the statistical analysis exceeds a predetermined threshold value; and
if it is determined that the result of the statistical analysis does not exceed the predetermined threshold value, then repeating the above steps of;
accessing a trial database, producing a grouped database, performing a statistical analysis, and determining while the clinical trial is ongoing. - View Dependent Claims (13, 14, 15, 16, 17)
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18. A system for continuously analyzing an ongoing clinical trial comprising:
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a storage device operable to store a trial database containing trial data of subjects in an ongoing clinical trial;
a processor coupled to the storage device; and
an analysis program executable by the processor and operable to;
perform a statistical analysis on the trial database;
determine whether the output result of the statistical analysis exceeds a predetermined threshold value; and
repeat the statistical analysis while the clinical trial is ongoing if it is determined that the result of the statistical analysis does not exceed the predetermined threshold value. - View Dependent Claims (19, 20, 21, 22, 23, 24)
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Specification