How to decrease the non-compliance in a clinical trial.
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.