Open -To Overcome failure to Publish nEgative fiNdings

The OPEN project is bringing together key opinion leaders from across Europe to address this issue. The first objective of OPEN is to identify and explore the current evidence on publication bias. Previous research has shown that publication bias exists in the scientific literature and that it significantly contributes to distorting evidence. Therefore, we will conduct systematic reviews to assess

1) the current state of the literature addressing the definitions and the nature of publication bias,

2) approaches of detecting publication bias in systematic reviews and approaches of measuring publication bias, and 3) the extent and impact of publication bias on systematic reviews and health technology assessments.

The second objective of OPEN is to describe current practice by various key groups involved in knowledge generation and translation in order to provide insights on how to avoid or reduce publication bias and to identify ways to change this practice. This will be addressed by assessing and evaluating the policies and procedures in place for preventing publication bias by the main parties involved in funding, conducting and publishing clinical research. These will include surveying funding agencies, the (pharmaceutical) industry, research ethics committees, research institutions, researchers, trial registers, biomedical journals, regulatory agencies, and benefit assessment agencies.

The findings of OPEN will provide the basis for a European consensus workshop which will address the issues raised. The results of OPEN and the subsequent workshop deliberations will result in recommendations for implementing effective measures to avoid publication bias at all levels. Participation and involvement of journal editors of the main European journals, including the BMJ (member of OPEN’s advisory board and member journals of the International Committee of Medical Journal editors, together with the leader of WP 6) and a representative from the Committee on Publication Ethics (COPE) (leader of WP 8) will further expedite the uptake of the resulting recommendations by the relevant institutions, particularly at the journal level.