Premature Discontinuation of Pediatric Randomized Controlled Trials : A Retrospective Cohort Study
| Autor: | Matthias Schwenkglenks, Heike Raatz, Per Olav Vandvik, Yuki Tomonaga, Dominik Mertz, Erik von Elm, Kelechi K Olu, Gordon H. Guyatt, Bernard Burnand, Elie A. Akl, Shanil Ebrahim, Matthias Briel, Sohail M. Mulla, Ignacio Neumann, Alonso Carrasco-Labra, Stefan Schandelmaier, Alain J Nordmann, Markus Faulhaber, Joerg J Meerpohl, Heiner C. Bucher, Alain Amstutz, Lars G. Hemkens, Lorenzo Moja, Theresa Bengough, Anette Bluemle, Ramon Saccilotto, Ignacio Ferreira-González, Bradley C. Johnston, Rachel Rosenthal, John J. You, Mihaela Stegert, Benjamin Kasenda, Kari A.O. Tikkinen, Viktoria Gloy, Martin A. Walter, Dirk Bassler, Jason W. Busse, Francois Lamontagne, Xin Sun |
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| Přispěvatelé: | Clinicum, Urologian yksikkö, Department of Surgery, Department of Public Health, HUS Abdominal Center |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
DATA MONITORING COMMITTEES
Canada Pediatrics medicine.medical_specialty EARLY TERMINATION law.invention RECRUITING CHILDREN Cohort Studies 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Risk Factors law 3123 Gynaecology and paediatrics Germany 030225 pediatrics Humans Medicine Data monitoring committee 030212 general & internal medicine ATTITUDES Risk factor Child INTERIM ANALYSIS Randomized Controlled Trials as Topic Retrospective Studies business.industry Retrospective cohort study Interim analysis 3. Good health Discontinuation Clinical trial Early Termination of Clinical Trials Pediatrics Perinatology and Child Health business Switzerland CLINICAL-TRIALS Cohort study CHILD HEALTH RESEARCH |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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