Endpoint development process

Abstract

A system for developing and producing clinical endpoints based on patient reported outcome data utilizing algorithms to generate decision rules to evaluate patient reported outcome type questionnaire is provided. The questionnaires can include health-related quality of life questionnaires and can predict the reliability of endpoints in supporting one or more medical labeling claims.

1 - 35 . (canceled) 
     
     
         36 . A method for configuring a prompting method of electronic devices in a clinical trial, said method comprising:
 a. prompting, by a first electronic device using a first prompting method of said electronic device, a first subject in a trial to input a response;   b. automatically recording said first subject's response to said first prompting method and storing first metadata indicating an amount of time elapsed between said first prompting and said response to said first prompting method, wherein said recording and storing occurs on said electronic device;   c. prompting, by a second electronic device using a second prompting method of said second electronic device, a second subject to input a response, wherein said first prompting method and said second prompting method are different;   d. automatically recording said second subject's response to said second prompting method and storing second metadata indicating an amount of time elapsed between said second prompting and said response to said second prompting method;   e. analyzing, by one or more electronic devices, said first metadata and said second metadata to evaluate effectiveness of said first prompting method and said second prompting method; and   f. selecting said first prompting method or said second prompting method for use during a subsequent clinical trial based on said analyzing said first metadata and said second metadata.   
     
     
         37 . The method of  claim 36 , wherein said first prompting method or said second prompting method is a random prompting method. 
     
     
         38 . The method of  claim 36 , wherein said first prompting method or said second prompting method is a scheduled prompting method. 
     
     
         39 . The method of  claim 36 , wherein said first prompting method or said second prompting method comprises beeping, a voice, music, or a vibration. 
     
     
         40 . The method of  claim 36 , wherein said trial is a pilot trial. 
     
     
         41 . A method for modifying operation of a portable electronic device in a clinical trial based on characteristics of a subject, said method comprising:
 a. prompting, by a first portable electronic device using a prompting method of said first portable electronic device, a subject in a trial to input a response,   b. automatically recording said subject's response to said prompting method and storing metadata comprising data related to said response to said prompting method, wherein said recording and storing occurs on said first portable electronic device;   c. analyzing said metadata; and   d. customizing a second portable electronic device for use in a clinical trial based on said analyzing, wherein said customizing comprises disabling or augmenting one or more physical features of said second portable electronic device based on said characteristics of said subject.   
     
     
         42 . The method of  claim 41 , wherein said prompting method is a scheduled prompting method. 
     
     
         43 . The method of  claim 41 , wherein said prompting method is a random prompting method. 
     
     
         44 . The method of  claim 41 , wherein said prompting method comprises beeping, a voice, music, or a vibration. 
     
     
         45 . The method of  claim 41 , wherein said metadata comprises information about patient-reported outcome (PRO) data. 
     
     
         46 . The method of  claim 41 , wherein said physical features comprises a keyboard, display, communications ability or security measures. 
     
     
         47 . The method of  claim 41 , wherein said characteristics comprises literacy, cognitive responsiveness or age. 
     
     
         48 . The method of  claim 41 , wherein said trial is a pilot trial.