Design considerations in an active medical product safety monitoring system.

  title={Design considerations in an active medical product safety monitoring system.},
  author={Joshua J Gagne and Bruce H Fireman and Patrick B. Ryan and Malcolm Maclure and Tobias Gerhard and Sengwee Toh and Jeremy A. Rassen and Jennifer C. Nelson and Sebastian Schneeweiss},
  journal={Pharmacoepidemiology and drug safety},
  volume={21 Suppl 1},
Active medical product monitoring systems, such as the Sentinel System, will utilize electronic healthcare data captured during routine health care. Safety signals that arise from these data may be spurious because of chance or bias, particularly confounding bias, given the observational nature of the data. Applying appropriate monitoring designs can filter out many false-positive and false-negative associations from the outset. Designs can be classified by whether they produce estimates based… CONTINUE READING

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