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  1. The qualification period.

    Article - En anglais

    For randomized trials that do not require prompt onset of therapy, a pre-admission preparation, called the qualification period, can deal with certain customary difficulties in design, analysis, and ethics.

    For the patients' baseline state, the qualification period can be used to « wash out » effects of previous treatment, to verify admission criteria, and to identify or stratify suitable prognostic indicators.

    For treatment, the qualification period can be used to test and adjust therapeutic dosages, to exclude placebo responders, and to confirm early responsiveness to long-term active therapy.

    Mots-clés Pascal : Essai clinique, Méthodologie, Admission hopital, Ethique, Consentement éclairé, Homme

    Mots-clés Pascal anglais : Clinical trial, Methodology, Hospital admission, Ethics, Informed consent, Human

    Logo du centre Notice produite par :
    Inist-CNRS - Institut de l'Information Scientifique et Technique

    Cote : 91-0438810

    Code Inist : 002B02A. Création : 199406.