Access to this article is restricted until 12 months after publication by request of the publisher.. Restriction lift date: 2017-09-16
Reporting on data monitoring committees in neonatal randomised controlled trials is inconsistent
No Thumbnail Available
Files
Accepted Version
Date
2016-09-16
Authors
Perrem, L. M.
Gosling, S.
Ravikumar, I.
Khashan, Ali S.
Miletin, J.
Ryan, C. Anthony
Dempsey, Eugene M.
Journal Title
Journal ISSN
Volume Title
Publisher
John Wiley & Sons, Inc.
Published Version
Abstract
Aim: To evaluate the reported use of Data Monitoring Committees (DMCs), the frequency of interim analysis, pre-specified stopping rules and early trial termination in neonatal randomised controlled trials (RCTs). Methods: We reviewed neonatal RCTs published in four high impact general medical journals, specifically looking at safety issues including documented involvement of a DMC, stated interim analysis, stopping rules and early trial termination. We searched all journal issues over an 11-year period (2003-2013) and recorded predefined parameters on each item for RCTs meeting inclusion criteria. Results: Seventy neonatal trials were identified in four general medical journals: Lancet, New England Journal of Medicine (NEJM), British Medical Journal and Journal of American Medical Association (JAMA). 43 (61.4%) studies reported the presence of a DMC, 36 (51.4%) explicitly mentioned interim analysis; stopping rules were reported in 15 (21.4%) RCTs and 7 (10%) trials were terminated early. The NEJM most frequently reported these parameters compared to the other three journals reviewed. Conclusion: While the majority of neonatal RCTs report on DMC involvement and interim analysis there is still scope for improvement. Clear documentation of safety related issues should be a central component of reporting in neonatal trials involving newborn infants.
Description
Keywords
Clinical trials , Randomised controlled trials , RCTs , Data monitoring committees , DMCs , Stopping rules , Interim analysis , Neonatal
Citation
Perrem, L. M., Gosling, S., Ravikumar, I., Khashan, A. S., Miletin, J., Ryan, C. A. and Dempsey, E. (2016) 'Reporting on data monitoring committees in neonatal randomised controlled trials is inconsistent', Acta Paediatrica, 106(1), pp. 30-33. doi: 10.1111/apa.13593
Copyright
© 2016, John Wiley & Sons, Inc. This is the peer reviewed version of the following article: Perrem, L.M., Gosling, S., Ravikumar, I., Khashan, A.S., Miletin, J., Ryan, C.A. and Dempsey, E. (2016) 'Reporting on Data Monitoring Committees in neonatal Randomised Controlled Trials is inconsistent', Acta Paediatrica, which has been published in final form at http://dx.doi.org/10.1111/apa.13593. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.