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Key Points

Results from clinical studies are an essential factor determining clinical as well as public health and policy decisions. It is therefore important that the results of all studies are presented in an unbiased and easily accessible manner. Health professionals and policymakers aspire to make healthcare decisions based on the entire relevant research evidence. This, however, can frequently not be achieved, to a large part because a considerable amount of research findings are not published; this phenomenon is called publication bias.

  • OPEN is bringing together key opinion leaders from across Europe to address the issue.
  • We will conduct a series of systematic reviews to assess the current state of the literature on publication bias, its definitions, its extent and its impact.
  • We will assess and evaluate the policies and procedures in place for preventing publication bias by the main parties involved in funding, conducting and publishing clinical research. This will include surveys of:

arrow funding agencies
the (pharmaceutical) industry
arrow research ethics committees
arrow research institutions
arrow researchers (authors and reviewers)
arrow trial registers
arrow biomedical journals
arrow regulatory agencies
arrow benefit assessment agencies

  • We will develop recommendations using the findings of OPEN and organise a European workshop.
  • The expected results of OPEN will be evidence-based recommendations for initiating the implementation of adequate measures to control publication bias and limit its effects on clinical decision making.