Data retention after a patient withdraws consent in clinical trials

作     者：Gabriel, Andre P. Mercado, Charles P. 

作者机构：Columbia Univ Med Ctr Dept Med New York NY 10032 USA 

出 版 物：《OPEN ACCESS JOURNAL OF CLINICAL TRIALS》 (临床试验杂志)

年 卷 期：2011年第3卷

页      面：15-19页

学科分类：100208[医学-临床检验诊断学] 1002[医学-临床医学] 1001[医学-基础医学(可授医学、理学学位)] 10[医学] 

基　　金：NINDS NIH HHS [U01 NS043975] Funding Source: Medline 

主　　题：withdrawal of consent patient follow-up guidance 

摘      要：Patient retention is critically important in the conduct of a successful clinical trial. The power in numbers in multicenter trials is dependent on the completion of follow-up for every patient randomized. If at the end of a clinical trial, a significant number of randomized patients are missing outcome data, there will not be enough pool for data analyses to conclude a study based on its primary and secondary objectives. When patients who are either lost to follow-up or who withdraw consent during the clinical trial are eliminated from the data pool, they subsequently affect the power and the validity of conclusions derived from the clinical study. This paper aims to present current guidance on data retention for patients who have withdrawn consent from clinical trials.