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Transparency in Europe: A Quantitative Study.

Frederic Bouder1, Dominic Way2, Ragnar Löfstedt2

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Risk Analysis : an Official Publication of the Society for Risk Analysis
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European regulators

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Area of Science:

  • Pharmacovigilance and Regulatory Science
  • Health Communication
  • Public Health Policy

Background:

  • European pharmaceutical regulators are increasing transparency by providing public access to clinical trial data.
  • This policy shift aims to improve risk-benefit communication for patients.
  • A systematic review of these new transparency policies is needed.

Purpose of the Study:

  • To explore the effects of new transparency policies on patient and public reactions.
  • To assess how European citizens respond to regulators' increased data access.
  • To inform evidence-based transparency policies integrating benefit-risk communication.

Main Methods:

  • A cross-national European survey was conducted.
  • The survey included 5,648 respondents from Great Britain, the Netherlands, Spain, France, Germany, and Sweden.
  • Data were analyzed to understand public reactions to transparency initiatives.

Main Results:

  • Significant national variations exist in how European citizens react to transparency policies.
  • Public reactions are influenced by cultural and societal factors across different European countries.
  • The study highlights the need for tailored communication strategies.

Conclusions:

  • Transparency policies require evidence-based development, considering national differences.
  • Effective benefit-risk communication is crucial for public trust and understanding.
  • Six recommendations are proposed to enhance the European transparency model in health and safety domains.