As medical writers, staying ahead of regulatory changes is crucial. The shift from ICH E6 R2 to ICH E6 R3 brings several updates that we need to be aware of to ensure our documentation remains compliant and effective. Here’s a breakdown of the key differences and their impact on our work.
- Embracing Risk-Based Approaches
ICH E6 R3 takes the concept of risk-based monitoring introduced in R2 and expands it to cover all aspects of trial management. This means we need to incorporate detailed risk management plans into our clinical trial documentation. Highlighting potential risks and mitigation strategies is now more important than ever. This shift requires us to have an in-depth understanding of risk assessment and management principles, ensuring our documents reflect a proactive approach to identifying and addressing risks.
- Strengthening Data Integrity
Data integrity has always been a cornerstone of clinical research, but ICH E6 R3 takes it a step further. Moving beyond the ALCOA principles, the new guideline introduces the concept of data reliability. Our task is to ensure that all data presented in clinical trial reports and regulatory submissions are not only accurate but also reliable and reproducible. This means that medical writers will need to learn how the data is produced and managed and to be familiar with documentation of data handling processes.
- Integrating Real-World Data
The inclusion of real-world data (RWD) and real-world evidence (RWE) in clinical trials is a significant update in ICH E6 R3. Leveraging data from routine clinical practice to complement traditional clinical trial data is becoming increasingly important. As medical writers, we need to be adept at integrating RWD and RWE into our reports, ensuring these data sources are appropriately documented and analyzed. This requires familiarity with new data sources and methodologies, as well as the ability to present complex data clearly and concisely.
- Enhancing Collaboration and Stakeholder Engagement
ICH E6 R3 emphasizes the importance of collaboration and stakeholder engagement throughout the clinical trial process. This includes greater involvement of patients, healthcare providers, and regulatory authorities in trial design and conduct. Our role is to document these collaborative efforts accurately, ensuring all stakeholder inputs are captured and reflected in trial documentation. This change necessitates strong communication skills and the ability to work effectively with diverse teams.
- Focusing on Quality by Design (QbD)
Quality by Design (QbD) principles are further reinforced in ICH E6 R3, promoting a systematic approach to trial design that ensures quality is built into every aspect of the trial. We need to incorporate QbD principles into our clinical trial protocols and reports, detailing how quality is maintained throughout the trial lifecycle. This involves a thorough understanding of QbD concepts and the ability to articulate how these principles are applied in practice.
Conclusion
The transition from ICH E6 R2 to ICH E6 R3 introduces several key changes that impact medical writers. By understanding and adapting to these changes, we can ensure our documentation meets the highest standards of quality and compliance. This not only supports the successful conduct of clinical trials but also contributes to the overall goal of improving patient outcomes through rigorous and reliable clinical research.
About the author:
Shiri Diskin, Chief Medical Writing Officer at Bioforum the Data Masters
Shiri holds a PhD in cell, molecular and developmental biology from Tufts University, USA. She has been a medical writer since 2009. Shiri worked as a medical writer and medical writing team leader at Teva until 2014. Currently, Shiri is the head of the medical writing department at Bioforum. Shiri is experienced in managing medical writing projects of early and late phase product development. Her expertise encompasses study-specific documents such as protocols and clinical study reports, as well as development-program documents such as investigator’s brochures and summaries of efficacy and safety. Shiri is experienced in close collaboration with multi-disciplinary clinical development teams, specifically safety, biostatistics and data management aimed at producing the highest-quality, most regulation-compliant, clear and informative documents while adhering to timelines. In addition to regulatory documents, Shiri is an expert in writing scientific journal articles. She writes and edits manuscripts and teaches workshops to medical doctors and scientists on this subject. Shiri is a lecturer at Tel Aviv University School of Medicine leading a course on medical writing to graduate students of regulatory science.