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Minerva Medica 2002 February;93(1):7-12

Copyright © 2002 EDIZIONI MINERVA MEDICA

language: English, Italian

How to decrease the non-compliance in a clinical trial

Baratelli G. M., Allio W., Lanzani A., Valsecchi P., Rotmensz N.


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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.

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