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How to decrease the non-compliance in a clinical trial
G M Baratelli1, W Allio, A Lanzani
1Delegazione Alto Lario della Lega Italiana per la Lotta contro i Tumori, Gravedona, Como, Italy. gm.bar@usa.net
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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