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 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.