Integrated data collection and analysis for clinical study
First Claim
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1. A system comprising:
- means for receiving a protocol for conducting a clinical study of a drug;
an implantable sensor for collecting study data from a plurality of patients enrolled in the study;
means for receiving the study data remotely from each of the plurality of patients enrolled in the study;
means for processing the received data according to the protocol to generate a conclusory output indicating a result of a current phase of the clinical study;
means for evaluating a response to an intake of the clinical trial drug of each of the plurality of patients based on the processed data;
means for developing a trend of a disease state for each of the plurality of patients based on the response;
means for predicating the occurrence of an adverse effect based on the developed trend;
means for evaluating patient safety based on the prediction of the occurrence of an adverse effect;
means for evaluating the risks to patient safety;
means for providing feedback to the patient based on the evaluation of the risk patient safety; and
means for determining the mode of the feedback to the patient based on the evaluation of the risk to patient safety.
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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.
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20 Claims
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1. A system comprising:
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means for receiving a protocol for conducting a clinical study of a drug; an implantable sensor for collecting study data from a plurality of patients enrolled in the study; means for receiving the study data remotely from each of the plurality of patients enrolled in the study; means for processing the received data according to the protocol to generate a conclusory output indicating a result of a current phase of the clinical study; means for evaluating a response to an intake of the clinical trial drug of each of the plurality of patients based on the processed data; means for developing a trend of a disease state for each of the plurality of patients based on the response; means for predicating the occurrence of an adverse effect based on the developed trend; means for evaluating patient safety based on the prediction of the occurrence of an adverse effect; means for evaluating the risks to patient safety; means for providing feedback to the patient based on the evaluation of the risk patient safety; and means for determining the mode of the feedback to the patient based on the evaluation of the risk to patient safety. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification