Pharmacogenomics-based clinical trial design recommendation and management system and method
First Claim
1. A pharmacogenomic system for clinical trials, the system comprising:
- a genotype database (GDB), the GDB comprising genetic information for a plurality of patients;
a clinical database (CDB), the CDB comprising clinical phenotypic information for a plurality of patients;
a clinical trial requirement database (CRDB), the CRDB comprising information on clinical trial requirements for at least one phase of a clinical trial;
association modules that are connected to GDB, and CDB and are adopted to determine an association between the genetic information and the clinical phenotypic information for a plurality of patients; and
recommendation modules that are connected to GDB, CDB, and CRDB and adopted to provide clinical trial recommendations utilizing the genetic information, the clinical phenotypic information, the clinical trial requirement information and the determined association between the clinical information and the genetic information.
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Abstract
The present invention relates to computer systems and methods for clinical trials for linking biological information including genomic and proteomic information to the conduct and success of the clinical trial process for therapeutic agents. In particular, the present invention relates to computer systems and methods of analyzing genotypes, clinical phenotypes, and clinical trial requirements for providing recommendations for conduct of various phases of clinical trial process. The system may include a genotype database, a clinical database, clinical trial requirements database, an analytical computer, a recommended trial database, a blood bank, and sequencing machines.
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Citations
26 Claims
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1. A pharmacogenomic system for clinical trials, the system comprising:
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a genotype database (GDB), the GDB comprising genetic information for a plurality of patients;
a clinical database (CDB), the CDB comprising clinical phenotypic information for a plurality of patients;
a clinical trial requirement database (CRDB), the CRDB comprising information on clinical trial requirements for at least one phase of a clinical trial;
association modules that are connected to GDB, and CDB and are adopted to determine an association between the genetic information and the clinical phenotypic information for a plurality of patients; and
recommendation modules that are connected to GDB, CDB, and CRDB and adopted to provide clinical trial recommendations utilizing the genetic information, the clinical phenotypic information, the clinical trial requirement information and the determined association between the clinical information and the genetic information. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A pharmacogenomic system for clinical trials, the system comprising:
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a genotype database (GDB), the GDB comprising genetic information for a plurality of patients;
a clinical database (CDB), the CDB comprising clinical phenotypic information for a plurality of patients;
a clinical trial requirement database (CRDB), the CRDB comprising information on clinical trial requirements for at least one phase of a clinical trial;
association means that are connected to GDB, and CDB and are adopted to determine an association between the genetic information and the clinical phenotypic information for a plurality of patients; and
recommendation means that are connected to GDB, CDB, and CRDB and adopted to provide clinical trial recommendations utilizing the genetic information, the clinical phenotypic information, the clinical trial requirement information and the determined association between the clinical information and the genetic information. - View Dependent Claims (10, 11, 12, 13, 14, 15, 16)
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17. A pharmacogenomic method for clinical trials, the method comprising the steps of:
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enabling a user to access a genotype database (GDB), the GDB comprising genetic information for a plurality of patients;
enabling a user to access a clinical database (CDB), the CDB comprising clinical phenotypic information for a plurality of patients;
enabling a user to access a clinical trial requirement database (CRDB), the CRDB comprising information on clinical trial requirements for at least one phase of a clinical trial;
enabling a user to determine an association between the genetic information and the clinical phenotypic information for a plurality of patients; and
enabling a user to cause the system to provide clinical trial recommendations utilizing the genetic information, the clinical phenotypic information, the clinical trial requirement information and the determined association between the clinical information and the genetic information. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24)
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25. A processor readable pharmacogenomic medium for clinical trials, said processor readable medium comprising:
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a first processor readable program code for enabling a user to access a genotype database (GDB), the GDB comprising genetic information for a plurality of patients;
a second processor readable program code for enabling a user to access a clinical database (CDB), the CDB comprising clinical phenotypic information for a plurality of patients;
a third processor readable program code for enabling a user to access a clinical trial requirement database (CRDB), the CRDB comprising information on clinical trial requirements for at least one phase of a clinical trial;
a fourth processor readable program code for enabling a user to determine an association between the genetic information and the clinical phenotypic information for a plurality of patients; and
a fifth processor readable program code for enabling a user to cause the system to provide clinical trial recommendations utilizing the genetic information, the clinical phenotypic information, the clinical trial requirement information and the determined association between the clinical information and the genetic information.
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26. A pharmacogenomic system for clinical trials, the system comprising:
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means for providing genetic information for a plurality of patients;
means for providing clinical phenotypic information for a plurality of patients;
means for providing information on clinical trial requirements for at least one phase of a clinical trial;
association modules that determine an association between the genetic information and the clinical phenotypic information for a plurality of patients; and
recommendation modules that provide clinical trial recommendations utilizing the genetic information, the clinical phenotypic information, the clinical trial requirement information and the determined association between the clinical information and the genetic information.
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Specification