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Designing Quality Clinical Trials: Unpacking E6(R3) and E8(R1)

My colleague, Sheila Gwizdak, VP of Quality at Halloran Consulting Group, led the discussion “Designing Quality Clinical Trials: Unpacking E6(R3) and E8(R1)” during last week’s Speaker Series. Like our attendees, I was looking forward to learning about these revisions.

To place a product on the market, regardless of region, compliance with GxP regulations is required. The health authorities from each country need to ensure that the product can be reverse-engineered (traceability), all individuals contributing and involved in the development process are identified (accountability), and that the data is reliable (data integrity). These three pillars – traceability, accountability, and data integrity – were repeated throughout the presentation and are common themes in the breakdown of these revisions.

Below you’ll find these revisions in context, an understanding of how to unpack them, and how to implement them to incorporate a proactive approach to quality during trial design.

ICH E8(R1) – General Considerations for Clinical Trials

Revision in context:

E8(R1) is steering quality in a new direction:

What are the updates?

What are the key principles?

In summary, the key principles that translate to quality are good design and execution.

What are critical to quality factors?

How does E8 link with E6?

E6(R3) – Good Clinical Practice

What are the updates?

What are the principles?

Complete implementation of E6(R2) before E6(R3)

So, Now What?

Both revisions – E6 and E8 – are embedding culture and processes that repeat quality outcomes centered around the patient. To begin your journey on a proactive approach to quality, implementing early-phase initiatives is critical to drive the quality of a study through the design of the protocol.

You’ll also need to determine the critical to quality factors for each study, which should not be a large list. In fact, the less is better when identifying non-essential activities of the study, which simplifies conduct, improves study efficiency, and targets resources to critical areas.

You’ll also need to evaluate and assess your people, process, and technology to identify gaps. If there are gaps, have a plan on your next steps.

Though this is a lot to consider, keep in mind that the health authorities do not expect perfection. What they expect is your effort at a proactive approach to quality outlined in these revisions.