Key Considerations For ICH-GCP Guidance On Quality Risk Management

By Ed Miseta, Chief Editor, Clinical Leader

By now, many of you are probably wondering about the recent adoption of the Good Clinical Practices (ICH E6 Guideline, R2). More specifically, you are likely wondering how it will apply to your own organization.

In this Q&A, Elizabeth Bodi, senior consultant at Halloran Consulting Group, answers some of your questions and sheds some light on the guidance and how it may impact research, resources, and patients.

Ed Miseta: What is the biggest change we might expect to see with the adoption of ICH E6, R2?

Elizabeth Bodi: For many sponsors and CROs, one of the biggest changes is definitely the incorporation of Quality Risk Management (QRM) principles into the design and execution of Clinical Trials. QRM has been around for more than ten years, largely in the manufacturing arena, and outlines the key steps for assessing, controlling, reviewing and communicating risk.  

There is a risk assessment stage, which will identify, analyze, and evaluate risk. The risk control stage will accept a certain amount of risk in some areas while attempting to reduce it in others. Finally, a review is performed of the results and output of the entire QRM process. Risk management tools will be used throught the process, with information communicated at every stage.  

Miseta: Will this create a greater burden on researchers?

Bodi: I don’t think so. At first glance this may feel like just another set of required tasks and documentation for an already over-burdened clinical organization. In fact, when done correctly QRM can save time and critical resources in the full clinical trial life cycle; from trial design, conduct, and oversight to data handling and regulatory reporting.

Miseta: So it sounds like, for a lot of companies, this is not something that will be totally new. 

Bodi: Exactly. Keep in mind that we are not starting from scratch. The ICH Q9 Guidance Document provides step-by-step guidance for setting up and executing QRM and provides useful tools for assessing and documenting risk. Also, we are not the first to utilize QRM. In the manufacturing arena they have been following QRM principles for more than 10 years. We have colleagues, consultants, articles, and best practices to fall back on and use to quickly get us up the learning curve.

Miseta: What are some other key points that companies should keep in mind?

Bodi: The foundation of QRM is to ensurethe safety of patients/subjects. No one would argue the importance of that. In fact, as someone who has worked in clinical research, I can tell you that is what we do every day in the clinical space. QRM simply provides a logical step-wise process for doing what we have always done in clinical, but doing it in a better and more structured manner.

If you think about it, what QRM really does is force up-front discussion and evaluation of risk. This ensures the industry takes a proactive rather than reactive approach to risk management. The sooner risk can be identified, the easier it is to address and resolve. In the long ruin, this will save both time and resources at the back-end. That is an outcome that will be good for the entire industry.

Miseta: Can you discuss how QRM will allow executives to better use their internal resources?

Bodi: Sure. First, QRM allows Clinical leadership to focus resources on the highest risk areas. This allows them to utilize staff more efficiently and effectively. The enterprise-wide use of QRM also means senior management will be able to roll up risk across the entire development lifecycle. This will lead to improved budget and timeline projections as well as making better informed go/no go decisions, which will result in significant cost savings for many companies.

I would also add that demonstrated adherence to QRM provides assurance to regulatory authorities that risks are being minimized. That is something regulators like to see, and may even lead to fewer and shorter inspections. That is something every sponsor company would like to see!

Miseta: How soon can companies expect to see results?

Bodi: I believe companies will start to see the benefits of embracing QRM processes in their clinical organization very quickly, especially now that ICH-GCP requires it. The next step for most companies will be to outline the steps for defining a roadmap to identify, evaluate, control, communicate, review and report QRM across the various functions and departments within their organization.