Background: Reporting bias is a significant barrier to the development of evidence-based medicine as it results in biased estimates of treatment benefits and harms. Turner (2012) identified that of five trials submitted to the FDA (US Food & Drug Administration) for approval of aripiprazole (Abilify) for treating schizophrenia, only three were published in the medical literature.

Objectives: To analyze and compare data on key outcomes reported in published randomized controlled trials (RCTs) and clinical study reports (CSRs) for the antipsychotic aripiprazole.

Methods: An inquiry was submitted to the European Medicines Agency, under the access-to-documents policy, seeking access to all CSRs submitted as part of marketing-authorization applications for aripiprazole by Otsuka. Trial characteristics from placebo-controlled RCTS were extracted to guide a search for any matching journal publications. A comparison will be conducted to determine differences between the regulator’s (CSRs) vs public’s (published RCT reports) view of the data on the following key outcomes: all-cause mortality, non-fatal serious adverse events, and quality of life. We will examine the effects of any discrepancies on the results of meta-analyses. Additionally, methods descriptions in published and unpublished trial reports, and assessment of risk of bias, will be compared.

Conclusions: Including data from sources other than traditional journal published RCTs may help to ameliorate the impact of reporting bias in systematic reviews, and produce a more balanced summary of benefits and harms. While the volume of data received is large, and may increase the complexity of the final analysis, access to CSRs may improve the reliability of systematic reviews and reduces the effects of reporting bias.