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.
Baratelli
G M
GM
Delegazione Alto Lario della Lega Italiana per la Lotta contro i Tumori, Gravedona, Como, Italy. gm.bar@usa.net
Allio
W
W
Lanzani
A
A
Valsecchi
P
P
Rotmensz
N
N
D000328:Adult; D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage; D001943:Breast Neoplasms / Q000517:prevention & control; D004311:Double-Blind Method; D020847:Estrogen Receptor Modulators / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007558:Italy; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000592:standards*; D010349:Patient Compliance / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012107:Research Design; D013629:Tamoxifen / Q000008:administration & dosage
D018931:Antineoplastic Agents, Hormonal; D020847:Estrogen Receptor Modulators; D013629:Tamoxifen