Evaluation and development of measures to uncover and overcome bias due to non-publication of clinical trials

The UNCOVER project is a direct contribution to overcome non-publication of clinical studies that have been designed and executed as randomized controlled trials (RCTs). RCTs provide the best utility as input to systematic medicinal reviews, one cornerstone of evidence-based medicine. That is provided that, and only then, RCTs are both correctly registered and published at least once. Because non-publication, as well as publication with time delay of RTCs, can decisively reduce the advantage of such systematic reviews of drugs, medical devices or procedures, it affects the knowledge base, patient value, and level of public health.

UNCOVERs aim is three-fold:
1) to apply established and develop novel, solid, and useful methods for fact-finding and interventions into the socio-economic system defined by causes and sources of the publication bias;
2) to engage with stakeholders and identify strategies, barriers, and facilitating factors associated with the publication bias and its consequences; and
3) to synthesize lessons learned and recommend feasible measures to deal with the publication bias.

In a perspective way, this project contributes pro better allocation of funds to sponsor studies and patient value, and contra duplication of work and patients risk. The issues of the publication bias are treated with quantitative, qualitative and participatory means (including tools such as stakeholder maps, institutional analysis, case studies, systematic reviews, interviews, bibliometric analysis and software) in an interdisciplinary approach in areas with little or no lines of evidence as to how they perform in practice. UNCOVER will thus both provide viable solutions for the publication bias, for better allocation efficiency of medicinal and health related research funds, and develop methodologies for future bias research efforts.