Reporting on data monitoring committees in neonatal randomised controlled trials is inconsistent
Perrem, L. M.; Gosling, S.; Ravikumar, I.; Khashan, Ali S.; Miletin, J.; Ryan, C. Anthony; Dempsey, Eugene M.
Date:
2016-09-16
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.
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Access to this article is restricted until 12 months after publication by request of the publisher.
Restriction lift date:
2017-09-16
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. doi: 10.1111/apa.13593
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.
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