Scope, definition, and consequences of publication bias in clinical trials

Objectives

  • Definition of the conceptual base of publication bias to establish a common understanding of its scope and consequences in clinical trials and to provide a frame of reference for the project-inherent multidisciplinary research approach involving systems analyses, evidence-based medicine, and evaluation research (Task 1.1)
  • Identification of stakeholders and grouping of them according to their specific roles and rationalities (mapping) (Task 1.2)

Task 1.1 - Definition and scope of publication bias

  • Definition and scope of publication bias and its consequences
  • Definitions, relevant terms and conceptual boundaries of the topic area,
  • Searching and screening of existing evidence on publication bias in the medical field, specifically with respect to clinical trials – main sources and types of evidence will be explored and identified as well as key concepts, theories, sources of evidence, and gaps in the research field described´

Task 1.2 - Stakeholder mapping

  • Identification and mapping of stakeholders in clinical trials and the publication of research outcomes
  • Grouping stakeholders according to specific roles and rationalities
  • Continual extension of the initial list of roles/functions during activities WP3 and WP5
  • Qualification of interactions between stakeholder groups according to generic types: monetary, knowledge scientific, legal, or power