By Abby Abraham, Vice President, Data Analytics and Risk-Based Monitoring
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) prescribed Good Clinical Practice (GCP) has undergone significant updates in the newly finalized ICH GCP E6 Revision 2. The impact of this change is expected to be rapid with the European Medicines Agency (EMA) already adopting the addendum in June 2017.
Different stakeholders in the industry, especially sponsors and clinical research organizations (CROs) are coming to terms with these new requirements. Organizations utilizing traditional models of clinical research conduct and monitoring are in different stages of process gap identification and solution planning to become ICH E6 (R2) compliant. Understandably, there are challenges to building or modifying processes and methodologies on the existing clinical execution model, which addressed ICH-GCP requirements when the last amendment was implemented more than 20 years ago.
The changes in ICH E6 (R2) are in many ways driven by recent innovations in technology and the ability to now manage data in a more efficient manner, but also encompass best practices adopted from other industries, such as manufacturing and aeronautics. Large pharma and CROs that have evolved with changing times by adopting data-driven and risk-based approaches to monitoring are in a better place today because these approaches form the backbone of the new requirements. However, there are a significant number of organizations in the industry that have not previously had the requirement to explore such processes and are now faced with a need to quickly become compliant with the new guideline regulatory agencies will soon adapt. This paper discusses important aspects to consider while implementing ICH E6 (R2) in these organizations.