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Minerva Med ; 93(1): 7-12, 2002 Feb.
Article in English, Italian | MEDLINE | ID: mdl-11850610

ABSTRACT

BACKGROUND: A high compliance is an important scientific objective for a multicenter clinical trial and also an ethical responsibility. Some of non-compliance causes can be prevented during the enrollment phase by an accurate selection of subjects (quality of recruitment), other can be controlled after the recruitment, by a good organization of follow-up tests and visits (quality of organization). METHODS: The policy adopted in the Operative Center of the Delegazione Alto Lario della Lega Italiana per la Lotta contro i Tumori di Gravedona (Como) for obtaining a high compliance of women recruited in the Italian Tamoxifen Prevention Study are illustrated. RESULTS: The non-compliance rate of this center is low: 5.6 vs 23.3% of the whole Italian trial. CONCLUSIONS: The low non-compliance demonstrates the efficacy of the policy adopted.


Subject(s)
Multicenter Studies as Topic/standards , Patient Compliance/statistics & numerical data , Randomized Controlled Trials as Topic/standards , Adult , Aged , Antineoplastic Agents, Hormonal/administration & dosage , Breast Neoplasms/prevention & control , Double-Blind Method , Estrogen Receptor Modulators/administration & dosage , Female , Humans , Italy , Middle Aged , Research Design , Tamoxifen/administration & dosage
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