Premature Discontinuation of Pediatric Randomized Controlled Trials: A Retrospective Cohort Study.

Schandelmaier, Stefan; Tomonaga, Yuki; Bassler, Dirk; Meerpohl, Joerg J; von Elm, Erik; You, John J; Bluemle, Anette; Lamontagne, Francois; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; ... (2017). Premature Discontinuation of Pediatric Randomized Controlled Trials: A Retrospective Cohort Study. Journal of pediatrics, 184, 209-214.e1. Elsevier 10.1016/j.jpeds.2017.01.071

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OBJECTIVES

To determine the proportion of pediatric randomized controlled trials (RCTs) that are prematurely discontinued, examine the reasons for discontinuation, and compare the risk for recruitment failure in pediatric and adult RCTs.

STUDY DESIGN

A retrospective cohort study of RCTs approved by 1 of 6 Research Ethics Committees (RECs) in Switzerland, Germany, and Canada between 2000 and 2003. We recorded trial characteristics, trial discontinuation, and reasons for discontinuation from protocols, corresponding publications, REC files, and a survey of trialists.

RESULTS

We included 894 RCTs, of which 86 enrolled children and 808 enrolled adults. Forty percent of the pediatric RCTs and 29% of the adult RCTs were discontinued. Slow recruitment accounted for 56% of pediatric RCT discontinuations and 43% of adult RCT discontinuations. Multivariable logistic regression analyses suggested that pediatric RCT was not an independent risk factor for recruitment failure after adjustment for other potential risk factors (aOR, 1.22; 95% CI, 0.57-2.63). Independent risk factors were acute care setting (aOR, 4.00; 95% CI, 1.72-9.31), nonindustry sponsorship (aOR, 4.45; 95% CI, 2.59-7.65), and smaller planned sample size (aOR, 1.05; 95% CI 1.01-1.09, in decrements of 100 participants).

CONCLUSION

Forty percent of pediatric RCTs were discontinued prematurely, owing predominately to slow recruitment. Enrollment of children was not an independent risk factor for recruitment failure.

Item Type:

 Journal Article (Original Article)

Division/Institute:

 04 Faculty of Medicine > Department of Radiology, Neuroradiology and Nuclear Medicine (DRNN) > Clinic of Nuclear Medicine
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > Forschungsbereich Pavillon 52 > Forschungsgruppe Klinische Radiopharmazie
04 Faculty of Medicine > Pre-clinic Human Medicine > BioMedical Research (DBMR) > Forschungsbereich Pavillon 52 > Forschungsgruppe Klinische Radiopharmazie

UniBE Contributor:

 Gloy, Viktoria, Walter, Martin Alexander

Subjects:

 600 Technology > 610 Medicine & health

ISSN:

 0022-3476

Publisher:

 Elsevier

Language:

 English

Submitter:

 Franziska Nicoletti

Date Deposited:

 01 Mar 2018 15:29

Last Modified:

 05 Dec 2022 15:09

Publisher DOI:

 10.1016/j.jpeds.2017.01.071

PubMed ID:

 28410086

Uncontrolled Keywords:

 early termination of clinical trials (MeSH) pediatrics (MeSH) randomized controlled trials as a topic (MeSH) risk factors (MeSH)

BORIS DOI:

 10.7892/boris.109358

URI:

 https://boris.unibe.ch/id/eprint/109358

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