System for Clinical Trial Subject Compliance

• US 20150178473A1
• Filed: 12/22/2014
• Published: 06/25/2015
• Est. Priority Date: 04/02/2001
• Status: Abandoned Application

• Current Assignee: E Research Technology, Inc.
• Original Assignee: eResearchTechnology, Inc. (Explorer Holdings, Inc.)
• Inventors: Hufford, Michael, Peterson, David, Paty, Jean, Shiffman, Saul
• Application Number:
  US14/579,574
• Publication Number:
  US 20150178473A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: G06Q 10/0639 Performance analysis of employees; Performance analysis of enterprise or organisation operations
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

The present invention is designed to develop research protocols for clinical trials. The invention also can track and enhance subject compliance with a research protocol. The invention further provides evaluability data related to subject performance in the clinical trial. According to an alternative embodiment of the invention, a portable electronic device is used to query and collect data from the subject.

Claims

1-53. -53. (canceled)

54. A method of improving subject compliance during a clinical trial by determining and responding to subject non-compliance, the method comprising:

receiving data associated with a subject of the clinical trial, the data comprising;

clinical trial data provided by the subject in the clinical trial via a portable electronic device; and

evaluability data associated with the clinical trial data, the evaluability data indicating the suitability of the clinical trial data for use in the clinical trial;

applying, by a computer processor, a decision rule to the evaluability data;

determining, by the computer processor based at least on the application of the decision rule to the evaluability data, that the subject has not complied with a clinical trial protocol associated with the clinical trial; and

taking an action in response to the determination that the subject has not complied with the clinical trial protocol.

55. The method of claim 54, wherein the clinical trial data comprises data received by the portable electronic device from a physiological measurement device.

56. The method of claim 55, further comprising receiving, by the portable electronic device, the clinical trial data from the physiological measurement device.

57. The method of claim 54, wherein the clinical trial data comprises one or more of the following data:

a response to a question presented to the subject via a portable electronic device;

a report associated with administration of a medication to the subject;

a report associated with pain reduction;

a report associated with a bowel movement;

a report associated with an asthmatic episode; and

a cognitive measurement.

58. The method of claim 54, wherein taking the action comprises communicating an alert to one or more of the following recipients:

the subject; and

a researcher conducting the clinical trial.

59. The method of claim 58, wherein the alert comprises one or more of the following alerts:

an email message;

a text message; and

an automated call.

60. The method of claim 54, further comprising receiving the data associated with the subject of the clinical trial over a network from the portable electronic device;

wherein taking the action comprises communicating, by a server comprising the computer processor, an alert over the network.

61. The method of claim 54, wherein:

the portable electronic device comprises the computer processor; and

taking the action comprises displaying a visual alert on the portable electronic device.

62. The method of claim 54, further comprising assessing the subject'"'"'s response to the action.

63. The method of claim 54, wherein taking the action comprises determining that the clinical trial data should not be included in a result of the clinical trial.

64. The method of claim 54, wherein taking the action comprises determining that data associated with the subject should not be included in a result of the clinical trial.

65. The method of claim 54, wherein the evaluability data comprises data indicating timeliness of the clinical trial data.

66. The method of claim 54, further comprising selecting the clinical trial protocol from a plurality of clinical trial protocols based at least on one or more characteristics of the clinical trial.

67. The method of claim 54, wherein:

the decision rule comprises a compliance threshold; and

applying the decision rule to the evaluability data comprises determining whether the subject has met the compliance threshold.

68. The method of claim 54, wherein the decision rule is based at least on historical data obtained during a previous clinical trial.

69. The method of claim 68, wherein the decision rule is based at least on quantitative analysis of the historical data.

70. The method of claim 54, further comprising generating the decision rule based at least on one or more requirements specified by a sponsor of the clinical trial.

71. A non-transient computer-readable medium comprising instructions operable, when executed by one or more computer processors of a computer system, to cause the computer system to:

receive data associated with a subject of a clinical trial, the data comprising;

clinical trial data provided by the subject in the clinical trial via a portable electronic device; and

evaluability data associated with the clinical trial data, the evaluability data indicating the suitability of the clinical trial data for use in the clinical trial;

apply a decision rule to the evaluability data;

determine, based at least on the application of the decision rule to the evaluability data, that the subject has not complied with a clinical trial protocol associated with the clinical trial; and

take an action in response to the determination that the subject has not complied with the clinical trial protocol.

72. The medium of claim 71, wherein the clinical trial data comprises data received by the portable electronic device from a physiological measurement device.

73. The medium of claim 71, wherein the clinical trial data comprises one or more of the following data:

a response to a question presented to the subject via a portable electronic device;

a report associated with administration of a medication to the subject;

a report associated with pain reduction;

a report associated with a bowel movement;

a report associated with an asthmatic episode; and

a cognitive measurement.

74. The medium of claim 71, wherein taking the action comprises communicating an alert to one or more of the following recipients:

the subject; and

a researcher conducting the clinical trial.

75. The medium of claim 74, wherein the alert comprises one or more of the following alerts:

an email message;

a text message; and

an automated call.

76. The medium of claim 71, wherein:

the data is received by the computer system over a network from the portable electronic device; and

taking the action comprises communicating an alert over the network.

77. The medium of claim 71, wherein:

the computer system comprises the portable electronic device; and

taking the action comprises displaying a visual alert on the portable electronic device.

78. The medium of claim 71, wherein the instructions are further operable to cause the computer system to assess the subject'"'"'s response to the action.

79. The medium of claim 71, wherein taking the action comprises determining that the clinical trial data should not be included in a result of the clinical trial.

80. The medium of claim 71, wherein taking the action comprises determining that data associated with the subject should not be included in a result of the clinical trial.

81. The medium of claim 71, wherein the evaluability data comprises data indicating timeliness of the clinical trial data.

82. The medium of claim 71, wherein the instructions are further operable to cause the computer system to select the clinical trial protocol from a plurality of clinical trial protocols based at least on one or more characteristics of the clinical trial.

83. The medium of claim 71, wherein:

the decision rule comprises a compliance threshold; and

applying the decision rule to the evaluability data comprises determining whether the subject has met the compliance threshold.

84. The medium of claim 71, wherein the decision rule is based at least on historical data obtained during a previous clinical trial.

85. The medium of claim 84, wherein the decision rule is based at least quantitative analysis of the historical data.

86. The medium of claim 71, wherein the instructions are further operable to cause the computer system to generate the decision rule based at least on one or more requirements specified by a sponsor of the clinical trial.

87. The medium of claim 71, wherein the instructions are further operable to cause the computer system to:

generate a report comprising one or more portions of the data;

communicate the report over the network to one or more of the following recipients;

a researcher conducting the clinical trial; and

a sponsor of the clinical trial.

88. A system for determining and responding to subject non-compliance during a clinical trial, the system comprising:

one or more computer processors; and

a non-transient computer-readable medium comprising instructions operable, when executed by the one or more processors, to cause the system to;

receive data associated with a subject of a clinical trial, the data comprising;

clinical trial data provided by the subject in the clinical trial via a portable electronic device; and

evaluability data associated with the clinical trial data, the evaluability data indicating the suitability of the clinical trial data for use in the clinical trial;

apply a decision rule to the evaluability data;

determine, based at least on the application of the decision rule to the evaluability data, that the subject has not complied with a clinical trial protocol associated with the clinical trial; and

take an action in response to the determination that the subject has not complied with the clinical trial protocol.

89. The system of claim 88, wherein the clinical trial data comprises data received by the portable electronic device from a physiological measurement device.

90. The system of claim 88, wherein the clinical trial data comprises one or more of the following data:

a response to a question presented to the subject via a portable electronic device;

a report associated with administration of a medication to the subject;

a report associated with pain reduction;

a report associated with a bowel movement;

a report associated with an asthmatic episode; and

a cognitive measurement.

91. The system of claim 88, wherein taking the action comprises communicating an alert to one or more of the following recipients:

the subject; and

a researcher conducting the clinical trial.

92. The system of claim 91, wherein the alert comprises one or more of the following alerts:

an email message;

a text message; and

an automated call.

93. The system of claim 88, wherein:

the data is received by the computer system over a network from the portable electronic device; and

taking the action comprises communicating an alert over the network.

94. The system of claim 88, wherein:

the computer system comprises the portable electronic device; and

taking the action comprises displaying a visual alert on the portable electronic device.

95. The system of claim 88, wherein the instructions are further operable to cause the system to assess the subject'"'"'s response to the action.

96. The system of claim 88, wherein taking the action comprises determining that the clinical trial data should not be included in a result of the clinical trial.

97. The system of claim 88, wherein taking the action comprises determining that data associated with the subject should not be included in a result of the clinical trial.

98. The system of claim 88, wherein the evaluability data comprises data indicating timeliness of the clinical trial data.

99. The system of claim 88, wherein the instructions are further operable to cause the system to select the clinical trial protocol from a plurality of clinical trial protocols based at least on one or more characteristics of the clinical trial.

100. The system of claim 88, wherein:

the decision rule comprises a compliance threshold; and

applying the decision rule to the evaluability data comprises determining whether the subject has met the compliance threshold.

101. The system of claim 88, wherein the decision rule is based at least on historical data obtained during a previous clinical trial.

102. The system of claim 101, wherein the decision rule is based at least quantitative analysis of the historical data.

103. The system of claim 88, wherein the instructions are further operable to cause the system to generate the decision rule based at least on one or more requirements specified by a sponsor of the clinical trial.

104. The system of claim 88, wherein the instructions are further operable to cause the system to:

generate a report comprising one or more portions of the data;

communicate the report over the network to one or more of the following recipients;

a researcher conducting the clinical trial; and

a sponsor of the clinical trial.