|was a 24-month project (running from November 1, 2011 to October 31, 2013) co-funded by the European Commission under the Seventh Framework Programme.|
"To Overcome failure to Publish nEgative fiNdings"
Results from clinical studies are an essential factor determining clinical decision making. It is therefore important that the results of all studies are presented in an unbiased and easily accessible manner. Health professionals and policymakers should make healthcare decisions based on the entire relevant research evidence, not on partial or skewed 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.
Publication bias results from the tendency of authors to submit, and of journals to accept, manuscripts for publication based on the direction or strength of the study findings. If manuscripts are not published because of an undesirable direction or perceived lack of strength of its findings, that evidence will not contribute towards advancing science. However, patients who participate in clinical research and the funding bodies who provide financial support do so with the clear understanding that their contributions will add to the progress of scientific knowledge. Publication bias therefore wastes considerable human and financial resources and skews the evidence base.
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.
OPEN will raise awareness of the effects of publication bias and highlight its impact on various individual and institutional groups involved. This will be achieved by assessing the status quo of the evidence and surveying the major institutions involved regarding their policies and procedures in place to avoid publication bias. Our first aim is to highlight the problem and formulate recommendations aiming at reduction and prevention of publication bias. Our second and ultimate aim is to initiate the implementation of more adequate mechanisms to control publication bias.
The research leading to these results has received funding from the European Union Seventh Framework Programme (FP7 – HEALTH.2011.4.1-2) under grant agreement n° 285453.