System for Clinical Trial Subject Compliance
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.
1 .- 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.