System for Clinical Trial Subject Compliance

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.

Having described the invention, what is claimed as new and protected by Letters Patent is: 
     
         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.