The use of interim data and Data Monitoring Committee recommendations in randomized controlled trial reports: frequency, implications and potential sources of bias

Puvan Tharmanathan¹ , Melanie Calvert¹ , John Hampton² and Nick Freemantle¹

¹Department of Primary Care and General Practice, University of Birmingham, Birmingham, UK

²Division of Cardiovascular Medicine, Queen's Medical Centre, Nottingham, UK

author email corresponding author email

BMC Medical Research Methodology 2008, 8:12doi:10.1186/1471-2288-8-12


Published:	20 March 2008

Additional files

Additional file 1:

RCTs identified as having extended use of interim analysis or extended recommendations made by DMCs, with potential to introduce bias. A list of trials identified as having reported extended use of interim analysis or recommendations by DMCs with the potential to introduce bias. Trials are sorted based on the interim trends observed or reason for interim analysis related recommendation. ^ CVD-Cardiovascular Disease, INF-Infection, OBGYN-Obstetrics and Gynecology, ONC-Oncology, NEURO-Neurology. Information in brackets:. * R denotes a regulatory trial or that the intervention was investigational when the trial was completed and DMC denotes specification of a DMC in the trial publication. DMC specified in 24/28 cases, R trials: 9/28 cases. ** TTE denotes time to event. *** Information in brackets: TA denotes that treatment arm specific rate were analyzed during interim analysis, OA denotes that overall rates were analyzed during interim analysis, Masked denotes that masking of data was maintained during interim analysis (where specified/reported in the trial publication).

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