Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

State-of-the-Art Reporting of Clinical Trial Results - Suitability of ICH E3 in a Changing Regulatory Landscape ***

Dr. Sabrina Stöhr (Abschlußjahr: 2022)

Summary
Language: English
The clinical development landscape has been subject to substantial changes in trial design, globalization, digitalization, and transparency. This thesis analyzed the more than 25-year-old ICH E3 guideline for its suitability in state-of-the-art reporting of clinical trial results. The analysis focused on applicable EU legislations, such as the Clinical Trial Regulation 536/2014 (EU-CTR), and the recently revised ICH guidelines. In addition, the two industry derived tools, the CORE Reference and the TransCelerate CSR template, were analyzed for their suitability to bridge the identified gaps.
Although Ich E3 was not meant to be used as authorative Clinical Study Report (CSR) template, its unintentionally implied format has been the basis for many sponsor templates. The revision ICH E3 Q&A has still failed to clear up this misunderstanding. This thesis analyzed the inherent structural flaws and inconsistencies of ICH E3 leading to overly complex and redundant CSRs. Both the CORE Reference and the TransCelerate CSR template were analyzed for their approaches to the identified structural flaws of ICH E3 and both tools provide valuable solutions.
In addition to the evolution of clinical development and the renovation of GCP, the new EU CTR will have a huge impact on results reporting and posting. ICH E3 alone is not sufficient to deliver a CSR that is technically state-of-the-art and fit for purpose between the poles of maximum transparency and protection of personal data and commercially confidential information. A revision of ICH E3 is overdue and would be one of the logical next steps in a holistic renovation of ICH Efficacy guidelines.
The thesis also shows that an authorative template is not a recommended solution, but the CORE Reference and TransCelerate CSR template are valuable tools to develop a sponsor customized CSR template.
Pages: 56
Annexes: 3, pages 12