Invention Grant
US07752057B2 System and method for continuous data analysis of an ongoing clinical trial
有权
正在进行的临床试验的连续数据分析的系统和方法
- Patent Title: System and method for continuous data analysis of an ongoing clinical trial
- Patent Title (中): 正在进行的临床试验的连续数据分析的系统和方法
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Application No.: US11810483Application Date: 2007-06-06
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Publication No.: US07752057B2Publication Date: 2010-07-06
- Inventor: Edward F. Ikeguchi , Glen M. Devries , Tarek A. Sherif , Edwin Goodman
- Applicant: Edward F. Ikeguchi , Glen M. Devries , Tarek A. Sherif , Edwin Goodman
- Applicant Address: US NY New York
- Assignee: Medidata Solutions, Inc.
- Current Assignee: Medidata Solutions, Inc.
- Current Assignee Address: US NY New York
- Agency: Hoffman & Baron, LLP
- Main IPC: G06Q10/00
- IPC: G06Q10/00

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.
Public/Granted literature
- US20080046469A1 System and method for continuous data analysis of an ongoing clinical trial Public/Granted day:2008-02-21
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