Preparing for ICH GCP E6 R3

The International Council for Harmonization’s (ICH) guidelines received a major update in 2023 with the introduction of ICH E6(R3). This new protocol provides an outline for ensuring patient safety and data quality during clinical trials. It also establishes processes for complying with regulatory requirements and industry guidelines.

Since R2 is considered the gold standard for Good Clinical Practice, updating your protocols to align with R3 makes a lot of sense. Doing so illustrates your commitment to quality and aligns your operation with fellow industry leaders.

In this white paper, we look at the differences between R2 and R3, so you can familiarize yourself with the new protocols and hit the ground running.

ICH E6(R3): What’s new?

ICH E6(R3) presents several changes, but it’s important to remember that it doesn’t completely overhaul R2. Instead, R3 aims to enhance quality and security and assist clinical teams in transitioning. Some of the most noticeable changes include:

• The Sponsor section emphasizes a proactive and forward-thinking approach to quality. More specifically, it encourages decision-makers to build quality into trial design and operations from day one.
• R2 principles were moved into a new section: 11 new Principles of GCP.
• R3 introduces two new principles: risk proportionality and roles and responsibilities. Risk proportionality focuses on participant safety and result quality. Furthermore, it encourages trial designers to consider potential risks beyond those linked to traditional medical care. Roles and responsibilities, on the other hand, clarifies the responsibilities of sponsors and investigators, to ensure appropriate oversight.
• Several new terms have been added to the glossary, including audit trail, data acquisition tool, metadata, and Reference Safety Information.
• Trial subjects are now referred to as Trial Participants.
• The definition of Clinical Trial has been updated to any interventional investigation.
• Annexes have been introduced to make future updates easier.
• Appendices have been added.

Admittedly, this is a lot of information to process. You might even be wondering why all of these changes are necessary. The updates in R3 can be attributed to the clinical trial landscape post-COVID-19. The rise of decentralized and remote clinical trials has introduced various new technologies that when used improperly could put patient safety and data integrity at risk. R3 aims to address these challenges in ways that are both actionable and affordable.

Still confused? Most of these changes can be broken down into four takeaways. These include:

1) Technology and Infrastructure

Decentralized and remote clinical trials save time, money, and resources, but without in-person interactions, safety and data quality can easily fall by the wayside. R3 encourages decision-makers to take a more risk-based approach to monitoring. It argues that investing in remote monitoring technologies and other similar systems can provide peace of mind and ensure research integrity.

2) Cultural shift

Clinical trials have always followed a rigid set of rules and protocols. That might have worked up until 2020, but a lot has changed over the last few years. By focusing on flexible, risk-based approaches, ICH E6 (R3) hopes to inspire cultural change from the top down.

3) Implementation effort

The updates in ICH E6 (R3) encourage trial designers and other decision-makers to evaluate their Standard Operating Procedures (SOPs) and existing practices. Rather than toe the line and accept the status quo, it aims to spur lasting change.

4) Potential resistance

Transitioning from R2 to R3 isn’t something that can happen overnight. It requires a willingness to change and do things differently. This can be challenging for stakeholders who are comfortable with “the way things have always been done.” R3 takes this into account and provides an outline for organizations that want to implement these new initiatives.

How to prepare for ICH GCP E6(R3)

If you’re a CRO, sponsor, clinical trial investigator, or other key stakeholder, familiarizing yourself with ICH GCP E6(R3) is essential. We recommend:

Reviewing the draft guidance

Set aside some time to read through the ICH GCP E6(R3) draft guidance. (Click here to access the document). Familiarize yourself with all the changes, so you can start implementing them in your organization.

Implementing change management initiatives

Change isn’t easy, but it’s not something to be afraid of either. Do everything you can to foster a company culture of collaboration, innovation, and openness. Specifically, think of ways to enhance communication between various departments. Encourage leadership to get involved and embrace the unknown.

Planning ahead

Evaluate the things your organization already does to support data quality and patient safety. Then, look at where potential gaps exist, and develop a plan to address them. That could mean investing in new technology, bringing in an outside expert for help, or simply making small changes that compound over time.

Familiarizing yourself with ICH GCP E6(R3) might seem like a hassle, but it’s worth your time and energy. Doing so will enhance the safety of trial participants, bolster the research you’re already doing, and ensure research outcomes are credible and reliable.

Need help getting the ball rolling? Our GxP experts are standing by. Email us at [email protected].