Clinical trials in psychiatry: should protocol deviation censor patient data?

@article{Lavori1992ClinicalTI,
  title={Clinical trials in psychiatry: should protocol deviation censor patient data?},
  author={Philip W. Lavori},
  journal={Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology},
  year={1992},
  volume={6 1},
  pages={39-48; discussion 49-63}
}
  • Philip W. Lavori
  • Published 1992 in
    Neuropsychopharmacology : official publication of…
Clinical trials methodologists recommend counting all events regardless of adherence to protocol and comparing originally randomized groups. This strict "intent-to-treat" policy implies availability and use of outcome measures taken regardless of adherence to treatment protocol. However, outcome measurement in psychiatry requires the cooperation of the patient, and usually occurs in the context of treatment management. Consequently, the patient's or clinician's decision not to adhere to the… CONTINUE READING

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