Vignet, Inc.

Other

Dave Klein

Praduman Jain

Josh Schilling

Yue Cao

Neeta Jain

Mark James Begale

Addisu Alemu

Aditya Krishnamurthy Naik

Kent John Lockhart

Bakare Swapnil Shamsundar

Methods, systems, and apparatus, including computer programs encoded on computer storage media, for managing and adapting monitoring programs. In some implementations, a system communicates with a set of remote devices involved in a monitoring program that involves collection of data from the remote devices over a communication network. The system determines a set of attributes associated with an outcome or condition that has occurred for multiple of the remote devices. The system generates parameters to adapt the monitoring program, and the system selects a second group of remote devices to involve in the adapted monitoring program based on profiles or sets of attributes of users associated with the remote devices. The system configures the remote devices in the selected second group to perform monitoring for the adapted monitoring program, including acquiring data for the adapted monitoring program and providing the acquired data to a server over the communication network.

Adapting data collection in clinical research and digital therapeutics

In some implementations, a system dynamically adjusts an electronic form of an application based on user data and form data specified for the electronic form. Form data that specifies characteristics of the electronic form is initially received by a computing device. The form data specifies one or more rules configured to vary the content of the electronic form that is presented for different users. User data indicating characteristics of a user is then obtained by the computing device. An interactive element is then selected from among a set of multiple interactive elements based on the received user data and the rules in the received form data. A view of the electronic form is customized for the user by including, in the customized view, the interactive element. The view of the customized electronic form is then displayed by the computing device.

Real-world evidence using patient-generated, multi-modal data for clinical research

Methods, systems, and apparatus, including computer programs encoded on a computer storage medium, for customizing monitoring programs involving remote devices. In some implementations, at least one of subject attribute data describing characteristics of subjects or subject outcome data including results from monitoring programs that involved the subjects are extracted from a subject database. The subjects are grouped into different groups according to levels of similarity among attributes of the subjects or monitored outcomes for the subjects. A profile is constructed for a group which includes defining inclusion criteria for the group based on aggregate data for the subjects in the group. Data sets are used in the subject database to characterize, for each profile, differing effects of elements of monitoring programs on program compliance outcomes for subjects that satisfy the criteria of the profile. The characterization data is used to create or adjust a monitoring program that involves communicating with a selected set of remote devices over the communication network.

Digital Health Systems to increase diversity and data quality in clinical trials

In some implementations, a system stores a repository of application features available for a software application. The system provides a program adjustment interface for administrators to create and edit programs accessed through the software application by remote client devices. The system receives input through the program adjustment interface that alters a particular program, and in response, the system updates stored program data for the particular program to change the combination of application features from the repository that are provided in the particular program. The system sends configuration data to one or more client devices over a computer network, wherein the configuration data is configured to change a set of application features for the software application that are stored at the one or more client devices and are used to provide interaction of the particular program with users of the one or more client devices.

Increasing engagement in clinical trials by adjusting applications based on patient usage data

Methods, systems, and apparatus, including computer-readable media encoded with computer program instructions, for a decentralized application ecosystem and data sharing platform. In some implementations, a system stores data for different individuals in different logical data storage areas. The system stores data indicating a set of predetermined data classifications, and for at least some of the data storage areas, the system determines and stores data classifications for data stored in an encrypted form in the data storage area. The system provides an application programming interface (API) that enables multiple different applications to access the data storage areas over a communication network. The system is configured to (i) provide access through the API to the data of data storage areas, conditioned on applications providing authorization tokens, and (ii) provide access through the API to the data classifications in the metadata that is not conditioned on providing authorization tokens.

Finding participants for decentralized clinical trials

Methods, systems, and apparatus, including computer programs encoded on a computer storage medium, for adapting digital trial to increase protocol compliance and retention. In some implementations, a system accesses (i) study data indicating a type of data to be collected in a research study and (ii) attribute data indicating attributes of participants in a cohort for the research study. The system identifies a set of technology items that are each capable of collecting the type of data indicated by the study data. The system determines a predicted level of compliance for each of the technology items in the set. The system selects a technology item for participants in the cohort to use in the research study based on the predicted levels of compliance. The system updates records for the research study to specify the selected technology item.

Improving compliance of patient data collection in clinical trials with predictive analysis

Methods, systems, and apparatus, including computer-readable media, for a hierarchical multi-tenant data access platforms. In some implementations, the a server system stores data collected through a multi-tenant data access platform configured to collect data for each of multiple tenant organizations and to selectively make the collected data available according to policies associated with the respective tenant organizations. The server system receives a request associated with a user, and the server system generates and provides a response according to the organization hierarchy data and policy data for the unit of the organization that has data that would be used in generating the response to the request.

Providing access to clinical trial data to research study teams

In some implementations, a system collects data from remote devices over a communication network, including first monitoring data for a first monitoring program and second monitoring data for a second monitoring program. The system evaluates the second monitoring data obtained for the second monitoring program. Based on the evaluation, the system determines that the monitoring data indicates that one or more criteria for adjusting the first monitoring program based on the second monitoring program are satisfied. The system selects one or more elements of the second monitoring program that are different from elements of the first monitoring program. The system alters the first monitoring program to include the selected one or more elements of the second monitoring program.

Accelerated clinical trials using patient-centered, adaptive digital health tools

In some implementations, after a first monitoring program has begun, a system receives input from a user corresponding to a second monitoring program that is related to the first monitoring program. The system provides data indicating one or more candidate items that can be monitored in the second monitoring program. The system receives user input indicating a selection from among the candidate items that specifies a set of physiological and behavioral attributes to be monitored in the second monitoring program. The system generates software or configuration data configured to implement monitoring for the second monitoring program for a subset of the first group of devices for the first monitoring program. The system provides the generated software or configuration data to the subset of the first group of devices to change data collection performed by the devices in the subset of the first group of devices.

Digital systems for managing health data collection in decentralized clinical trials

Methods, systems, and apparatus, including computer programs encoded on a computer storage medium, for configuring devices and software for data collection in clinical research. In some implementations, a database includes information describing characteristics of different technology items and configuration elements corresponding to the different technology items, the configuration elements enabling use of different functions of the technology items. The system identifies a particular technology item selected to be used by participants in a research study. The system retrieves a configuration element from the database that corresponds to the particular technology item and is adapted to enable capture or transmission of data using the particular technology item. The system provides the retrieved configuration element to one or more devices associated with the research study to facilitate implementation of data collection using the particular technology item.

Increasing data quality of patient-generated information in clinical research by configuring devices and software

Methods, systems, and apparatus, including computer programs encoded on a computer storage medium, for monitoring technology usage and data quality in decentralized pharmaceutical trials. In some implementations, a system receives data collected using one or more technology items for participants in a clinical trial that involves use of a pharmaceutical by the participants. The system evaluates usage of the one or more technology items by the participants in the clinical trial at multiple times during the clinical trial to determine whether the participants use the one or more technology items according to a protocol for the clinical trial or whether the collected data provides a level of data quality needed. The system determines, based on the evaluation, that one or more requirements for the clinical trial are not satisfied. In response, the system provides a notification to one or more devices of a researcher associated with the clinical trial.

Monitoring technology usage and data quality in decentralized pharmaceutical trials

Methods, systems, and apparatus, including computer programs encoded on computer-storage media, for automated contact tracing using multiple data sources. In some implementations, a system uses location data generated based on one or more types of signals, such as GPS signals, WI-FI signals, signals from cellular base stations, signals from short-range wireless technology, and so on. The system also prompts users for information regarding their locations and the conditions present at the locations, either at the time a user is present or later. With this information, the system compares the tracked locations for different individuals to identify instances of contacts in which criteria for disease transmission potential are met, e.g., when two individuals have certain levels of proximity and timing. Detected instances of contacts can be used to inform individuals.

Increasing diversity and engagement in clinical trails through digital tools for health data collection

In some implementations, a system enables an administrator to customize a set of rules to dynamically adjust the configuration and output of an application provided to users. A configuration interface for setting rules that dynamically adjust output of an application is provided. Data indicating one or more rules are received through the configuration interface. Activity data indicating user interaction with the application or sensor data for at least some of a plurality of users of the application are then received from multiple client devices. A determination relating to the activity data satisfying at least one condition or trigger is then made. Instructions to adjust output of the application according to one or more system actions of the one or more rules are then communicated to client devices associated with the users in the first subset of the plurality of users.

Automating interactions for health data collection and patient engagement

Methods, systems, and apparatus, including computer programs encoded on computer storage media, for conditional monitoring using different groups of remote devices. In some implementations, a system accesses data indicating characteristics for a monitoring program that involves data collection from a plurality of remote devices over a communication network. The system identifies a group of candidates for the monitoring program and, based on outcomes of other monitoring programs, the system generates a prediction for a level of compliance of the group with the requirements of the monitoring program. The system generates one or more scores indicative of whether the monitoring program will satisfy one or more predetermined conditions needed for successful completion of the monitoring program. Based on the generated one or more scores, the system provides a notification over the communication network that is indicative of whether the monitoring program will satisfy one or more predetermined conditions.

Machine learning to predict patient engagement and retention in clinical trials and increase compliance with study aims

Methods, systems, and apparatus, including computer programs encoded on computer-storage media, for providing interfaces for altering operation of remote devices. In some implementations, a system stores monitoring parameter values for a monitoring program, where the monitoring parameter values specify data collection to perform using remote devices. The system collects monitoring data from remote devices over a communication network according to the monitoring parameter values for the monitoring program. The system provides user interface data for a user interface that presents or describes at least a portion of the monitoring data collected for the monitoring program. In response to user interaction with a displayed element in the user interface, the system can present (i) a monitoring parameter value used to collect data represented by the displayed element and (ii) an interactive user interface element configured to adjust collection of the type of data represented by the display element.

Growing community of inventors

Oakton, VA, United States of America

Dave Klein