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

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.

journal_name

Minerva Med

journal_title

Minerva medica

authors

Baratelli GM,Allio W,Lanzani A,Valsecchi P,Rotmensz N

keywords:

subject

Has Abstract

pub_date

2002-02-01 00:00:00

pages

7-12

issue

1

eissn

0026-4806

issn

1827-1669

journal_volume

93

pub_type

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