Menu
Back to Journals » Open Access Journal of Clinical Trials » Volume 3
Data retention after a patient withdraws consent in clinical trials
Published 18 April 2011 Volume 2011:3 Pages 15—19
DOI https://doi.org/10.2147/OAJCT.S13960
Review by Single anonymous peer review
Peer reviewer comments 2
André P Gabriel, Charles P Mercado
Department of Medicine, Columbia University Medical Center, New York, NY, USA
Abstract: 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 This paper aims to present current guidance on data retention for patients who have withdrawn consent from clinical trials.
Keywords: withdrawal of consent, patient follow-up, guidance
© 2011 The Author(s). This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.
By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.