Integrated data collection and analysis for clinical study
OwnerJohn St. Ores, Sarah Audet +4inventors
InventorsJohn St. Ores, Sarah Audet, James Carney, Janell Gottesman, Adrianus Donders, Michael Ujhelyi
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Abstract
A data collection system includes remote, implantable sensors for monitoring one or more patient parameters, collecting and processing data from those sensors and utilizing that data in the performance of a clinical study of a drug or other pharmacological agent. The system assists with preparation of a protocol for a clinical trial; presentation of that protocol; assuring compliance with the protocol; and generating useful results from data collected via the system and externally for presentation to an approval forum.
Claims20
A method of conducting a clinical trial for a drug comprising:
- generating a protocol for conducting the clinical trial for the drug and providing the protocol to a host data collection system;
- implanting an implantable sensor into a plurality of patients enrolled in the clinical trial, where the implantable sensor provides data to the host data collection system;
- collecting data from the implantable sensor at the host data collection system during the clinical trial;
- analyzing the data collected at the host data collection system;
- and
- submitting a conclusion of the clinical study based upon the analyzed data to a reviewing authority.
The method of clam 3, further comprising receiving mandated modifications from the investigational review board at the host data collection system, wherein the host data collection system generates a revised protocol for presentation to a sponsor of the study based upon the mandated modifications.
An electronic system for conducting a clinical trial for a drug, the system comprising:
- a server, the server including:
- a protocol module for maintaining a protocol for the clinical trial;
- a communication interface for facilitating electronic communication remote from the server;
- and
- a database including a patient record for each of the patients enrolled in the clinical trial for the drug and associated with the electronic system;
- a sponsor interface for providing electronic communication between the server and a sponsor of the clinical trial for the drug;
- and
- a plurality of implantable sensors for implantation into a plurality of the patients enrolled in the clinical trial for the drug, wherein the plurality of implantable sensors sense a parameter relevant to an evaluation of the drug in the clinical trial and the parameter is communicated from a given implantable sensor to the server and associated with the patient record in the database corresponding to the given implantable sensor.
Dependencies are inferred from the claim text.