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Integrated data collection and analysis for clinical study

  • US 7,594,889 B2
  • Filed: 03/31/2005
  • Issued: 09/29/2009
  • Est. Priority Date: 03/31/2005
  • Status: Active Grant
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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