The ICH Guideline “Good Clinical Practice” (the E6 directive) is in revision. This revision will impact the ICH-GCP requirements worldwide. This is a special moment because this is the first change since the GCP directive 20 years ago was published. Currently, the input on the review is discussed within the ICH and the parties have agreed on the content. The final document will be written this summer and possibly be effective later this year.
“ICH-GCP goes risk-based”
What are the main changes? The directive is updated with the way we currently do drug research: more on a global level, more complex studies and with more use of CROs. Also, the contemporary use of technological applications included in the directive, such as application of online and mobile data collection, other forms of electronic data capture and real time review of clinical data. Finally, mitigating factors are removed: there is less emphasis on full monitoring of each data point, in this revision it is a risk-based approach.
What does ICH GCP with this update?
With this revision ICH want to make it easier to introduce efficient working methods in clinical drug studies, for example in study management (remote monitoring and oversight) and data management (electronic data capture). This would cost pharmaceutical research less time and money, but delivers the new regulations, especially an improvement of data integrity and indirectly improve the protection of clinical trial subjects.
We’ll keep you up to date with the changes and the revisions. Want to know more? Viewhere the full text of the new ICH-GCP E6 revision. In a subsequent news item we will have more detail on the substantive amendments to the directive.