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Activity Number: 372
Type: Contributed
Date/Time: Tuesday, August 11, 2015 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #317940
Title: Shortcomings of the CONSORT 2010 Statement in the Reporting of Adaptive Trials
Author(s): Steven A. Julious* and Munyaradzi Dimairo and Abigail Stevely and Susan Todd
Companies: University of Sheffield and University of Sheffield and University of Sheffield and University of Reading
Keywords: CONSORT 2010 ; adaptive designs ; group sequential trials ; clinical trials

It could be argued that adaptive designs are underutilised. There are however concerns linked to inadequate their reporting. We examined compliance in the reporting of group sequential RCTs in published trials. We undertook a systematic review by searching Ovid MEDLINE (2001 to 2014). Eligible trials were examined for compliance in their reporting against the CONSORT 2010. Proposed modifications were added to capture group sequential specific aspects. Of the 284 screened trials, 68(24%) were eligible. Most trials were published in "high impact" medical journals. Reports examination established that 46(68%) were stopped early. Suboptimal compliance was found in items relating to: access to full trials protocols; methods to generate randomisation list(s) and details of randomisation concealment. Group sequential aspects were largely inadequately reported. Only 3(7%) trials which stopped early reported use of statistical bias correction. Conclusions: There are issues with the reporting of group sequential RCTs. The robustness of RCTs that stop early can be questioned. These issues could be alleviated by modification to the CONSORT statement.

Authors who are presenting talks have a * after their name.

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