Abstract
Subject retention is as important as subject recruitment. Losing subjects is actually worse for study results than not having randomized the subject at all. There are multiple methods to impute missing data, but none are as good as having retained the subject in follow-up. The site can use many methods to maintain subject retention, including providing a stipend for visits, providing transportation or travel assistance, and having great staff. Having regular visits, albeit not too frequent, has been shown to be helpful. Letters can be sent to the primary care physicians, to the subjects regarding study milestones, and to the subjects once the randomization unblinding occurs. There are multiple steps that can be used if a subject wishes to withdraw consent that allow the critical information, like vital status, to be maintained.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Little RJ, D'agostino R, Cohen ML, et al. The prevention and treatment of missing data in clinical trials. N Engl J Med. 2012;367:1355–60.
Food & Drug Administration. Guidance for sponsors, clinical investigators, and IRB’s: data retention when subjects withdraw from FDA-regulated clinical trials. 2008. https://www.research.usf.edu/dric/quality-improvement/docs/Data-Retention-When-Subjects-Withdraw.pdf.
Dziura JD, Post LA, Zhao Q, et al. Strategies for dealing with missing data in clinical trials: from design to analysis. Yale J Biol Med. 2013;86:343–58.
Kearney A, Daykin A, Shaw ARG, et al. Identifying research priorities for effective retention strategies in clinical trials. Trials. 2017;18:406.
Brown MT, Bussell JK. Medication adherence: WHO cares? Mayo Clin Proc. 2011;86:304–14.
Author information
Authors and Affiliations
Rights and permissions
Copyright information
© 2018 Springer International Publishing AG, part of Springer Nature
About this chapter
Cite this chapter
East, C. (2018). Maintaining Subject Retention and Avoiding Study Fatigue. In: Developing a Successful Clinical Research Program. Springer, Cham. https://doi.org/10.1007/978-3-319-54693-3_14
Download citation
DOI: https://doi.org/10.1007/978-3-319-54693-3_14
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-54692-6
Online ISBN: 978-3-319-54693-3
eBook Packages: MedicineMedicine (R0)