Regulatory perspectives on data monitoring.

  title={Regulatory perspectives on data monitoring.},
  author={Robert O'Neill},
  journal={Statistics in medicine},
  volume={21 19},
Data monitoring is a critical component of the conduct of clinical trials that provide the evidence of efficacy and safety of investigational drugs. These trials may be conducted either by a pharmaceutical sponsor or by the government, especially those large trials that assess the impact of therapies on serious morbidity and/or mortality. While not extensive, I will review a regulatory history of FDA's evolving concerns and positions on data monitoring. I will review the key aspects of data… CONTINUE READING

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