The OPEN project brought together experts and academics from across Europe to address the issue of non-publication (or more broadly, non-dissemination) of clinical research findings. Results from clinical studies play an essential role in clinical decision making, and publication bias severely impacts the quality of this decision-making process. Between November 2011 and October 2013, the OPEN (Overcome failure to Publish nEgative fiNdings) project conducted a series of systematic reviews to assess the current state of the literature on publication bias, its definitions, its extent and its impact.
On 5th May 2015, BMJ Open published the evidence-based OPEN recommendations on how to reduce publication bias, and minimise its impact on clinical decision making. The full report can be found here.
What can be done?
The report recognises that the dissemination of clinical research is complex and involves many different people and organisations, including; funding agencies, pharmaceutical and device companies, research institutions, researchers, research ethics committees, trial registries, journals, regulatory agencies, drug benefit assessors, and legislators.
The report recommends 4 principles that apply to all of the groups identified. To overcome the problem of publication bias, everybody involved in the clinical trial publication process should:
- Raise awareness about dissemination bias and measures to reduce it
- Disseminate and facilitate the implementation of targeted OPEN recommendations (see practical recommendations below)
- Promote trial registration and posting of results, and support initiatives that facilitate searches across multiple trial registries
- Support activities to systematically, with rigorous methodology, synthesise information from studies
Beyond the 4 principle recommendations, the report identified 47 practical recommendations that target each individual group in turn. These provide clear guidance on activities that should be undertaken by each of the different groups. Click here to read the practical recommendations that apply to your organisation.
What should you do now?
We encourage you to adopt the 4 principle recommendations and act on the practical recommendations in the report that apply to you.
Is your organisation already acting on the recommendations? Are there any barriers that you are struggling to overcome? Tell us so that we can share your experience with over 560 organisations who have joined the campaign. Contact us to share your experience.