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The issue of reporting bias is well-known and non-publication of clinical trial results is unfortunately common. Various initiatives have been implemented to remedy this issue such as the FDA Amendments act in September 2007, which requires submission of results to a publicly accessible database within 12 months of study completion. However, this act only applies to a subset of Phase II-IV trials and not all clinical research.

Highlights in this white paper include:

Reporting bias is a well-known issue with widespread occurrence of the non-publication of clinical trial results. Prior estimates of publication rates were limited to specific types of trials, and select sources for results. This white paper aims to clarify the reporting rate for industry-sponsored trials across multiple sources using broader criteria, and see what the status is for this issue. 

 

  • Percentage of completed studies reporting final or interim results, with a comparison of peer-reviewed vs. ClinicalTrials.gov results 
  • Publication rates for Phase II and III trials by source, therapeutic area, and sponsor
  • Trial outcomes for Phase II and Phase III trials reporting results
 
Sept2014_Reporting-Bias-in-Clinical-Trials_Doro-Shin

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