Conflict of interest: Nothing to declare.
Randomization is not associated with socio-economic and demographic factors in a multi-center clinical trial of children with sickle cell anemia
Article first published online: 22 APR 2014
© 2014 Wiley Periodicals, Inc.
Pediatric Blood & Cancer
Volume 61, Issue 9, pages 1529–1535, September 2014
How to Cite
Roberts, D. O., Covert, B., Rodeghier, M. J., Parmar, N., DeBaun, M. R., Thompson, A. A. and Liem, R. I. (2014), Randomization is not associated with socio-economic and demographic factors in a multi-center clinical trial of children with sickle cell anemia. Pediatr. Blood Cancer, 61: 1529–1535. doi: 10.1002/pbc.25072
Roberts and Covert contributed equally to this work.
- Issue published online: 17 JUL 2014
- Article first published online: 22 APR 2014
- Manuscript Accepted: 25 MAR 2014
- Manuscript Received: 19 SEP 2013
- SIT Trial (M.R.D.). Grant Number: 5U01-NS042804-07
- clinical trials;
- research participation;
- sickle cell disease;
- study recruitment
Few studies have investigated factors influencing participation rates for minority children with a chronic disease in clinical trials. The Silent Cerebral Infarct Multi-Center Clinical (SIT) Trial provides an opportunity to study the impact of demographic and socio-economic factors on randomization in a clinical trial among Black children. Our primary objective was to characterize the factors associated with successful randomization of children with sickle cell disease (SCD) and silent cerebral infarct (SCI) in the SIT Trial after initial consent.
Differences in socio-economic and demographic variables, family history and disease-related variables were determined between eligible participants who were successfully randomized and those who were not randomized following initial consent. Head of household educational level and family income were examined separately for US versus non-US sites.
Of 1,176 children enrolled in the SIT Trial, 1,016 (86%) completed screening. Of 208 (20%) children with qualifying SCI on pre-randomization MRI, 196 (94%) were successfully randomized. There were no differences in socio-economic, demographic, or disease-related variables between children who were or were not randomized. Participants from non-US sites were more likely to be randomized (22% vs. 12%, P = 0.011); although, randomization by country was associated with neither head of household education nor family income.
In the SIT Trial, acceptance of random allocation was not associated with socio-economic or demographic factors. Although these factors may represent barriers for some participants, they should not bias investigators caring for children with SCD in their approach to recruitment for clinical trial participation. Pediatr Blood Cancer 2014;61:1529–1535. © 2014 Wiley Periodicals, Inc.