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Reporting on data monitoring committees in neonatal randomised controlled trials is inconsistent
Author(s) -
Perrem LM,
Gosling S,
Ravikumar I,
Khashan AS,
Miletin J,
Ryan CA,
Dempsey E
Publication year - 2017
Publication title -
acta paediatrica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.772
H-Index - 115
eISSN - 1651-2227
pISSN - 0803-5253
DOI - 10.1111/apa.13593
Subject(s) - interim , medicine , randomized controlled trial , interim analysis , data monitoring committee , pediatrics , clinical trial , family medicine , surgery , archaeology , history
Aim To evaluate the reported use of data monitoring committees ( DMC s), the frequency of interim analysis, prespecified stopping rules and early trial termination in neonatal randomised controlled trials ( RCT s). Methods We reviewed neonatal RCT s 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 RCT s 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. A total of 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%) RCT s and seven (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 RCT s 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.