The “eagerly awaited” revision to ICH E6 is going to provide a clear message about the expectation for how a clinical trial is conducted in today’s world compared to the world of the mid 1990’s when the first version was adopted by the three ICH regions.
ICH E6 is by definition a guideline and therefore provides guidance, i.e. it informs of expectation but doesn’t lay out any of the “how”. Therefore it leaves it up to individual organisations to decide how to implement the revision and to determine what compliance looks like. That is the big issue industry is struggling to cope with today – it’s up to us to decide what successful implementation looks like and the fear of getting it wrong is leading to inertia for many, currently.
However, this is our opportunity take a fresh look at what we do and to really think about what we are trying to achieve in conducting a clinical trial, and to plan with the end in mind.
In implementing the revision we need to understand that “one size won’t fit all.” Each organisation needs to decide what works for them. The guidance gives us the latitude to do this.
What do we need?
- Well thought through, practical, pragmatic, simple, efficient, fit for purpose processes that do what we need to in order to deliver ICH E6 R2 compliant studies and no more
- With particular reference to section 5 of the revision, processes that state what we do including a clear plan, provide documented evidence of what we did to execute the plan and follow the processes i.e. a clear audit trail to build a strong evidence based case for why we took the actions we did, when and why which will stand up to scrutiny during regulatory agency inspection and marketing application review.
Provided we can do the above we can defend our position with confidence. It’s as simple as that.
What do I do if I’d like some advice?
TRI are specialists in helping your CRO or Pharma company to find the best route to compliance, and then assisting you in achieving that as efficiently as possible.
If you would like help in getting your Rev 2 compliance project up and running then please contact us using the link below:
We would love to hear from you