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Evidence-informed recommendations to reduce dissemination bias in clinical research: conclusions from the OPEN project

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The aims of the OPEN project (http://www.open-project.eu) are to assess the current evidence on publication bias and to describe current practices by various key groups involved in funding, conducting and publishing clinical research in order to provide insights on how to avoid or reduce publication bias.

A paper published in BMJ Open this week presents almost 50 different recommendations from the OPEN project on how to reduce publication bias. These recommendation are based on discussions from an international consensus meeting.

The paper is aimed at funding agencies, pharmaceutical and device companies, research institutions, researchers (systematic reviewers and trialists), research ethics committees, trial registries, journal editors and publishers, regulatory agencies, benefit assessment institutions, and legislators.

Targeted recommendation for each of these key stakeholder groups can be found in a table here.

Recommendations for Pharmaceutical and Device companies include:

  • Making their policies concerning the dissemination of methods and results of clinical trials publicly accessible (strong recommendation)
  • Registering all clinical trials in a public registry before the recruitment of the first participant (strong recommendation)
  • Making their trial protocols+amendments (as submitted to RECs) available on the publication/dissemination of results (strong recommendation)
  • Publishing/disseminating complete summary results (aggregate data) of all trials conducted and provide access to their CSRs (for clinical trials) on request (recommendation)

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