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 are currently best practice to avoid or minimize both systematic and random errors in clinical studies. They provide the most utility as input to systematic medicinal reviews, one cornerstone of evidence-based medicine for improved safety and efficacy/effectiveness of patient outcomes, and their end-users. However, that is provided that - and only then - RCTs are both correctly registered and published.
Non-publication (i.e. not distributing results properly to stakeholders) may decisively reduce the advantage of systematic reviews of drugs, medical devices or procedures. It affects the knowledge base, patient value per outcome, and the level of public health.
UNCOVER uses quantitative, qualitative and participatory approaches. It aims at
- applying established and developing novel and useful methods for fact-finding and interventions into the socioeconomic system defined by causes and sources of the publication bias;
- interviews with stakeholders and identifying strategies, barriers, and facilitating factors of the publication bias and its consequences; and
- recommending feasible measures to deal with the publication bias more effectively to the EC and other stakeholders.
UNCOVER will thus search for viable solutions against publication bias: for better allocation efficiency of medicinal and health related research funds, higher patient value, and reduced duplication of work.
Proposal full title: Evaluation and development of measures to uncover and overcome bias due to non-publication of clinical trials
Proposal acronym: UNCOVER
Type of funding scheme: Coordination and Support Action: Supporting (CSA-SA)
Work programme topics addressed: HEALTH.2011.4.1-2: Targeting publication bias
Project number: 282574
UNCOVER is an FP7-funded project under Contract No 282574