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.

What is claimed as new and protected by Letters Patent is: 
     
         1 . A method of protocol development for a clinical trial, comprising the steps of:
 a) selecting a clinical trial target reflecting a goal of the clinical trial;   b) determining desired evaluability data categories to be gathered pertaining to one or more participants in the clinical trial;   c) entering evaluability data about the one or more participants, of at least one of the evaluability data categories, on an electronic device; and   d) determining whether to retain the one or more participants in the clinical trial or to incorporate the one or more participants in at least one result of the clinical trial based on the evaluability data about the one or more participants entered on the electronic device.   
     
     
         2 . (canceled) 
     
     
         3 . The method of  claim 1 , further comprising e) generating at least one compliance enhancing feature. 
     
     
         4 .- 36 . (canceled) 
     
     
         37 . A compliance monitoring device for use in clinical trials, comprising:
 a portable electronic device capable of displaying information and receiving and storing input from a user,   wherein the user is provided feedback based on the determination of whether the user has followed a predetermined protocol for providing the input to the portable electronic device.   
     
     
         38 . The compliance monitoring device of  claim 37 , wherein the portable electronic device determines whether the user has followed a predetermined protocol for providing the input to the portable electronic device more closely as a function of having received the feedback. 
     
     
         39 .- 53 . (canceled) 
     
     
         54 . The method of  claim 3 , wherein the at least one compliance enhancing feature includes a question to be posed to a subject to determine a reason for non-compliance. 
     
     
         55 . The method of  claim 3 , wherein the at least one compliance enhancing feature is active during execution of the clinical trial. 
     
     
         56 . The method of  claim 3 , wherein the at least one compliance enhancing feature is provided to a subject by a portable electronic device. 
     
     
         57 . The method of  claim 56 , wherein the portable electronic device guides a subject through the protocol. 
     
     
         58 . The method of  claim 56 , wherein the compliance enhancing feature comprises an alarm tone. 
     
     
         59 . A method of protocol development for a clinical trial comprising
 designing a compliance feature, wherein the designing comprises incorporating standard features, trial specific features, and evaluability needs; and   incorporating the compliance feature into the protocol.   
     
     
         60 . The method of  claim 59 , wherein the standard features comprise review of historic data from previous research. 
     
     
         61 . The method of  claim 59 , wherein the trial specific features comprise compliance targets based on a disease state being studied. 
     
     
         62 . The method of  claim 59 , wherein the evaluability needs comprise tailoring compliance features in order to maximize evaluability data. 
     
     
         63 . The method of  claim 59 , further comprising compliance tracking. 
     
     
         64 . The method of  claim 63 , wherein the compliance tracking comprises analyzing subject behavior data and comparing it to the protocol. 
     
     
         65 . The method of  claim 59 , further comprising providing compliance feedback to a subject, clinical staff, research site, or sponsor. 
     
     
         66 . The method of  claim 63 , further comprising forwarding compliance tracking data to an evaluability database. 
     
     
         67 . The method of  claim 66 , further comprising incorporating evaluability data in compliance tracking decisions during the course of a clinical trial. 
     
     
         68 . A non-transitory medium suitable for use in an electronic device and having instructions for execution on the electronic device the method of  claim 1 . 
     
     
         69 . A non-transitory medium suitable for use in an electronic device and having instructions for execution on the electronic device of the method of  claim 59 .