Immerse software-as-a-service patient empowerment platform for clinical trial participants

Abstract

Disclosed are a system and a computer implemented method for use in the course of a clinical trial and/or precision medicine, wherein patient metrics are acquired and the system comprises selected core modules, methods and/or automated services and selected empowerment apps.

1 . A system for use in a clinical trial and/or precision medicine, said system comprising
 a software platform configured to allow users can to create a user profile and to communicate with each other,   a storage unit configured to store application data and user data,   empowerment applications (apps) configured to build on platform services and/or functions of the software platform,   two or more core modules selected from the group consisting of personal health record module, messaging module, newsletter module, search module, blogging and discussion forums module, calendar module, notes module, application store and ecosystem module, location-based services module, rating module, payment services module, data exploration and analytics module,   a processor configured to analyze the application data and/or user data and to form a longitudinal database from the application data and/or user data,
 wherein the processor causes the system to at least: 
 acquire metrics, 
 document the acquired metrics as data points in the longitudinal database accessible by the users, and 
 provide two or more automated services, selected from the group consisting of retention service, rewards and incentive service, patient education service, reminder service, medication adherence and compliance service, self-reported outcomes, surveys and questionnaires service, community and social network service, reimbursement service, campaign service, A/B testing and combinations thereof. 
   
     
     
         2 . The system according to  claim 1 , wherein the users interacting with the platform are selected from the group consisting of patients, patient advocacy group members, investigators, physicians, sponsors and/or their representatives, preferred Clinical Research Associates (CRAs), researchers and combinations thereof. 
     
     
         3 . The system according to  claim 1  comprising the personal health record module, wherein the personal health record module comprises a central database for individual healthcare data, wherein data entries comprise a timestamp and a set of attributes and values prior to being stored. 
     
     
         4 . The system according to  claim 1 , wherein the processor is configured to allow the users can to filter and order data results accordingly to a specified location and/or their current location with the location-based services module. 
     
     
         5 . The system according to  claim 1  comprising the data exploration and analytics module, wherein the data exploration and analytics module is configured for: real-time exploration and analysis of data stored on the platform and/or flexible selection and filtering of specific subsets of data to meet user requirements and a combination across a variety of available data sources. 
     
     
         6 . The system according to  claim 1 , wherein the empowerment apps are selected from the group consisting of opt-in app, data return app, data sharing app, data donation app, personal message inbox app, tasks app, medication history app, pharmaceuticals and medication alerts app, investigators and doctors app, community and social network app, disease and treatment knowledge base app, personal performance dashboard app and combinations thereof. 
     
     
         7 . The system according to  claim 1 , further comprising a data return app, wherein the data return process comprises the sponsor being able to provide a Case Report Form (CRF) data, a Clinical Study Report (CSR), a lay summary, patient-specific summary, user-specific trial data, and to inform the patient and the investigator on its availability via the system being able to view and download the returned data via the system. 
     
     
         8 . The system according to  claim 1 , further comprising an opt-in app, wherein an opt-in process involves the patients, investigators and clinical research associates, and wherein the opt-in app is configured to allow:
 the patients to provide their consent, refer to terms of use or of participation in a clinical trial,   the investigators to explain their service and to support the patient, and   the clinical research associates to act as representative of a sponsor.   
     
     
         9 . The system according to  claim 1 , further comprising a data sharing app wherein the processor, via the data sharing app, is configured to allow the users to share their personal healthcare data with selected users or user groups with the data sharing app comprising
 creating a set of data items,   bundling the data items to a data set,   creation of a unique identifier, adapted to be accessible by the users or user groups with appropriate privileges only while access privileges granted.   
     
     
         10 . The system according to  claim 1 , further comprising an application with game playing elements and activities to trial-related activities. 
     
     
         11 . The system according to  claim 1 , wherein the platform forms a further longitudinal database of self-reported outcomes, preferred medication intakes and/or possible side effects-by and is adapted to combine data relating to latest information about user's current medication, user's medication history, related information, documented side effects and/or intake plans with surveys and/or documentation of self-reported outcomes provided by the patients on a regular basis. 
     
     
         12 . The system according to  claim 1 , wherein patient empowerment metrics are used for measurement and/or evaluation of patient's empowerment on the platform, during patient's participation in clinical programs, trials, and/or activities. 
     
     
         13 . The system according to  claim 1 , wherein patient empowerment metrics are selected from the group consisting of personal performance, quality of life, social interactions, disease, program knowledge, customer experience, medication adherence and medication compliance. 
     
     
         14 . The system according to  claim 1 , wherein at least one of the users is a patient participating in a clinical trial and the processor causes the system to de-identify the patient resulting in a de-identified patient and wherein a bi-directional communication between industry and the at least one de-identified patient is enabled during and after the clinical trial and the at least one de-identified patient remains de-identified during the bi-directional communication. 
     
     
         15 . The system according to  claim 1 , wherein the platform is configured to implement access rights management using Rule- (RuBAC) and Role-Based Access Control (RBAC) and
 Single-Sign On (SSO) functionality and   techniques for authentication.   
     
     
         16 . The system according to  claim 1 , wherein entities are selected from the group consisting of resources, permissions, roles, organizations, user groups, user and combinations thereof and/or profiles are defined in the platform's security roles concept. 
     
     
         17 . A computer implemented method for use in course of a clinical trial and/or precision medicine comprising:
 acquiring metrics   documenting the acquired metrics as data points in a longitudinal database accessible by users,   providing two or more core modules selected from the group consisting of personal health record module, messaging module, newsletter module, search module, blogging and discussion forums module, calendar module, notes module, application store and ecosystem module, location-based services module, rating module, payment services module, data exploration and analytics module, providing methods and/or automated services, selected from the group consisting of retention service, rewards and incentive service, patient education service, reminder service, medication adherence and compliance service, self-reported outcomes, surveys and questionnaires service, community and social network service, reimbursement service, campaign service, A/B testing and combinations thereof, and   building empowerment apps on platform services and/or functions.