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 increasing subject compliance during a clinical trial by improving oversight, the method comprising:
receiving, over a network from a first portable electronic device, first data associated with a first subject of the clinical trial, the first data comprising:
first clinical trial data provided by the first subject; and
first evaluability data associated with first clinical trial data, the first evaluability data indicating the suitability of the first clinical trial data for use in the clinical trial;
receiving, over the network from the first portable electronic device, second data associated with the first subject, the second data comprising:
second clinical trial data provided by the first subject after the provision of the first clinical trial data; and
second evaluability data associated with the second clinical trial data, the second evaluability data indicating the suitability of the second clinical trial data for use in the clinical trial;
generating, by a computer processor, a report providing a graphical display of the first and second evaluability data;
communicating 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.
55 . The method of claim 54 , further comprising receiving, over the network from a second portable electronic device, third data associated with a second subject of the clinical trial, the third data comprising:
third clinical trial data provided by the second subject; and
third evaluability data associated with third clinical trial data, the third evaluability data indicating the suitability of the third clinical trial data for use in the clinical trial;
wherein the report further provides a graphical display of the third evaluability data.
56 . The method of claim 54 , further comprising storing the first data in a database associated with a server comprising the computer processor.
57 . The method of claim 54 , wherein the first evaluability data comprises data indicating timeliness of the first clinical trial data.
58 . The method of claim 54 , wherein the first clinical trial data comprises one or more of the following data:
a response to a question presented to the first subject via a portable electronic device;
a report associated with administration of a medication to the first 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.
59 . The method of claim 54 , wherein the first clinical trial data comprises data received by the portable electronic device from a physiological measurement device.
60 . The method of claim 54 , further comprising administering a reward to the first subject based at least on the first evaluability data.
61 . 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, over a network from a first portable electronic device, first data associated with a first subject of the clinical trial, the first data comprising:
first clinical trial data provided by the first subject; and
first evaluability data associated with first clinical trial data, the first evaluability data indicating the suitability of the first clinical trial data for use in the clinical trial;
receive, over the network from the first portable electronic device, second data associated with the first subject, the second data comprising:
second clinical trial data provided by the first subject after the provision of the first clinical trial data; and
second evaluability data associated with the second clinical trial data, the second evaluability data indicating the suitability of the second clinical trial data for use in the clinical trial;
generate a report providing a graphical display of the first and second evaluability 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.
62 . The medium of claim 61 , wherein the instructions are further operable to cause the computer system to receive, over the network from a second portable electronic device, third data associated with a second subject of the clinical trial, the third data comprising:
third clinical trial data provided by the second subject; and
third evaluability data associated with third clinical trial data, the third evaluability data indicating the suitability of the third clinical trial data for use in the clinical trial;
wherein the report further provides a graphical display of the third evaluability data.
63 . The medium of claim 61 , wherein the instructions are further operable to cause the computer system to store the first data in a database associated with a server comprising the one or more computer processors.
64 . The medium of claim 61 , wherein the first evaluability data comprises data indicating timeliness of the first clinical trial data.
65 . The medium of claim 61 , wherein the first clinical trial data comprises one or more of the following data:
a response to a question presented to the first subject via a portable electronic device;
a report associated with administration of a medication to the first 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.
66 . The medium of claim 61 , wherein the first clinical trial data comprises data received by the portable electronic device from a physiological measurement device.
67 . The medium of claim 61 , wherein the instructions are further operable to cause the computer system to administer a reward to the first subject based at least on the first evaluability data.
68 . A system for reporting data related to 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 computer processors, to cause the system to:
receive, over a network from a first portable electronic device, first data associated with a first subject of the clinical trial, the first data comprising:
first clinical trial data provided by the first subject; and
first evaluability data associated with first clinical trial data, the first evaluability data indicating the suitability of the first clinical trial data for use in the clinical trial;
receive, over the network from the first portable electronic device, second data associated with the first subject, the second data comprising:
second clinical trial data provided by the first subject after the provision of the first clinical trial data; and
second evaluability data associated with the second clinical trial data, the second evaluability data indicating the suitability of the second clinical trial data for use in the clinical trial;
generate a report providing a graphical display of the first and second evaluability 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.
69 . The system of claim 68 , wherein the instructions are further operable to cause the system to receive, over the network from a second portable electronic device, third data associated with a second subject of the clinical trial, the third data comprising:
third clinical trial data provided by the second subject; and
third evaluability data associated with third clinical trial data, the third evaluability data indicating the suitability of the third clinical trial data for use in the clinical trial;
wherein the report further provides a graphical display of the third evaluability data.
70 . The system of claim 68 , wherein the instructions are further operable to cause the system to store the first data in a database associated with a server comprising the one or more computer processors.
71 . The system of claim 68 , wherein the first evaluability data comprises data indicating timeliness of the first clinical trial data.
72 . The system of claim 68 , wherein the first clinical trial data comprises one or more of the following data:
a response to a question presented to the first subject via a portable electronic device;
a report associated with administration of a medication to the first 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.
73 . The system of claim 68 , wherein the first clinical trial data comprises data received by the portable electronic device from a physiological measurement device.
74 . The system of claim 68 , wherein the instructions are further operable to cause the system to administer a reward to the first subject based at least on the first evaluability data.