Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Finding a balance between the need for comprehensive transparency in clinical trials and the protection of commercially confidential information in today’s regulatory environment

Eva Kreßner (Abschlußjahr: 2024)

Summary
Language: English
The thesis titled "Finding a balance between the need for comprehensive transparency in clinical trials and the protection of commercially confidential information in today’s regulatory environment" focuses on navigating the complex relationship between transparency and the protection of commercially confidential information (CCI) in clinical trials, particularly under the European Union's Clinical Trials Regulation (EU CTR) No 536/2014. The thesis addresses the conflicting expectations of key stakeholders, such as sponsors and patients, in clinical trials.
Clinical trials are vital for advancing medical knowledge and developing new therapies. However, the need for transparency to maintain scientific integrity and public trust often conflicts with the need to protect CCI. Sponsors aim to secure marketing authorizations and safeguard trade secrets, while patients demand access to information about new treatment options. The EU CTR, effective from January 2022, seeks to harmonize clinical trial approval processes across EU member states and the European Economic Area (EEA), enhancing transparency and participant safety.
This thesis concludes that while the EU CTR has made significant strides in promoting transparency, challenges remain, particularly in protecting CCI and ensuring stakeholder compliance. It recommends the following:

  • Improved Regulatory Compliance: Streamlining administrative processes and in-vesting in digital infrastructure to enhance regulatory compliance and reduce burdens on stakeholders.
  • Stakeholder Engagement: Encouraging active engagement with patients, advocacy groups, and the public to build trust and improve understanding of clinical trials.
  • Balanced Approach to CCI: Developing guidelines to protect CCI while ensuring transparency, fostering a culture of openness without compromising economic interests.
  • Continued Evolution of Transparency Practices: Emphasizing the need for ongoing updates and refinements to transparency guidelines, considering emerging challenges and innovations in clinical research.

This thesis highlights the delicate balance between transparency and CCI protection, emphasizing the importance of collaboration and innovation to achieve a more open and trustworthy clinical trial environment in the EU.
Pages: 97
Annexes: 01, Pages: 05

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