System and method for clinical trials

A method for monitoring patient compliance during a clinical trial through a user computational device accessed by a patient enrolled in a clinical trial;

• one or more wearable devices in communication with said user computational device, said wearable devices comprising sensors for continuously monitoring patient behavior and physiological parameters;
• and a server in communication with said user computational device through a computer network;
• the method comprising:
• continuously collecting real-time data from said wearable devices indicating patient behavior and physiological parameters during said clinical trial;
• transmitting said real-time data from said user computational device to said server through said computer network;
• analyzing, by an AI engine on said server, said real-time data to determine patient compliance with clinical trial protocol requirements;
• detecting, by said AI engine, when patient behavior deviates from expected patterns based on clinical trial parameters stored in a database;
• automatically adjusting, by said AI engine, timing of alarms and prompts sent to said user computational device within permitted time windows based on analysis of individual patient behavior patterns;
• generating, by said AI engine, protocol adjustments in response to detected compliance issues or routine disruptions while maintaining scientific rigor of said clinical trial;
• and
• establishing a dynamic feedback loop between continuous patient monitoring through said wearable devices and adaptive protocol management, enabling real-time adjustment of patient-facing instructions based on actual patient behavior data collected between clinical visits.

A system for monitoring patient compliance during a clinical trial, comprising:

• a user computational device accessed by a patient enrolled in a clinical trial;
• one or more wearable devices in communication with said user computational device, said wearable devices comprising sensors for monitoring patient behavior and physiological parameters;
• a server in communication with said user computational device through a computer network, said server comprising:
• a database for storing clinical trial parameters;
• and
• an AI engine configured to automatically construct a patient-facing protocol from said clinical trial parameters, said patient-facing protocol comprising specific instructions that determine when and how said patient is expected to interact with said wearable devices, when to complete questionnaires, and when to take other prescribed actions during said clinical trial;
• wherein said AI engine is further configured to:
• monitor real-time data from said wearable devices to determine patient compliance with said patient-facing protocol instructions;
• detect when patient behavior deviates from expectations defined in said patient-facing protocol;
• automatically adjust timing of alarms and prompts sent to said user computational device within permitted time windows specified in said patient-facing protocol based on analysis of individual patient behavior patterns;
• and
• dynamically modify said patient-facing protocol instructions in response to detected compliance issues or routine disruptions while maintaining scientific rigor of said clinical trial;
• wherein said patient-facing protocol serves as the operational framework that governs all patient interactions with said wearable devices, questionnaire completion schedules, and other trial-related actions, and wherein said system establishes a dynamic feedback loop between patient behavior monitoring and adaptive modification of said patient-facing protocol instructions.

A method for monitoring patient compliance during a clinical trial through a user computational device accessed by a patient enrolled in a clinical trial;

• one or more wearable devices in communication with said user computational device, said wearable devices comprising sensors for monitoring patient behavior and physiological parameters;
• and a server in communication with said user computational device through a computer network;
• the method comprising:
• automatically constructing, by an AI engine on said server, a patient-facing protocol from clinical trial parameters stored in a database, said patient-facing protocol comprising specific instructions that determine when and how said patient is expected to interact with said wearable devices, when to complete questionnaires, and when to take other prescribed actions during said clinical trial;
• implementing said patient-facing protocol as an operational framework that governs all patient interactions with said wearable devices, questionnaire completion schedules, and other trial-related actions;
• monitoring, by said AI engine, real-time data from said wearable devices to determine patient compliance with said patient-facing protocol instructions;
• detecting, by said AI engine, when patient behavior deviates from expectations defined in said patient-facing protocol;
• automatically adjusting, by said AI engine, timing of alarms and prompts sent to said user computational device within permitted time windows specified in said patient-facing protocol based on analysis of individual patient behavior patterns;
• dynamically modifying, by said AI engine, said patient-facing protocol instructions in response to detected compliance issues or routine disruptions while maintaining scientific rigor of said clinical trial;
• and
• establishing a dynamic feedback loop between patient behavior monitoring and adaptive modification of said patient-facing protocol instructions.