Community Research and Development Information Service - CORDIS

FP7

UNCOVER — Result In Brief

Project ID: 282574
Funded under: FP7-HEALTH
Country: Austria

Overcoming publication bias in clinical research

Clinical trials (CTs) evaluate the effectiveness and safety of medications, medical devices or medical procedures by monitoring their effects on large groups of people. EU-funded researchers investigated the effect of publication bias in CTs and provided recommendations to overcome this bias.
Overcoming publication bias in clinical research
In clinical research the term “publication bias” refers to biases related to the selective dissemination of research findings due to decisions that are based on some form of scientific, economic or political rationality. Publication bias affects the overall knowledge base negatively and threatens the validity of published clinical research results. Consequently, this bias could have adverse consequences for public health, and lead to duplication of research efforts when research findings are not shared and studies unnecessarily repeated. As a result, resources and time are wasted and patients participating in CTs are inadvertently misled in their understanding that they are contributing to the improvement of medical treatments

The UNCOVER project employed quantitative, qualitative and participatory means to develop recommendations to overcome publication bias. They focused predominantly on publication bias occurring from non-publication of CT outcomes.

UNCOVER members were hugely successful in their endeavours. Use of stakeholder maps, institutional analyses, a systematic review, interviews, scenario-building workshops, bibliometric analysis and software development helped identify key stakeholders and strategies to overcome non-publication of clinical studies.

Through a systematic review it became clear that current interventions to reduce publication bias are ineffective. Researchers came up with a multi-intervention strategy comprising three complementary approaches to combat publication bias. The Global Mandatory Approach highlights the necessity of a worldwide CT registry with a unique identification number for each CT and summaries of research outcomes. The Individualised Voluntary Approach interlinks funding with journal policy. The Catalytic Supplement is based on overall empowerment of health care professionals and institutions such as non-government organisations, patient organisations and education facilities. Implementation of these approaches would require the enforcement of both hard and soft laws as well as changes in reward policy.

UNCOVER consulted experts and stakeholders in scenario-building exercises to overcome publication bias and promote responsible research and innovation. As a result, researchers and stakeholders were able to develop together a roadmap for the implementation of feasible interventions that align clinical research with the societal needs in conducting and publishing clinical trials.

Kudos to UNCOVER for identifying barriers to overcoming publication bias and developing recommendations that will support evidence-based medicine with optimum resource allocation.

Related information

Subjects

Life Sciences

Keywords

Publication bias, clinical research, clinical trials, systematic review, participatory approach, health care
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