Risk-Based Quality Management for Dummies (like me!)

RBQM is officially promoted by the FDA. It's officially promoted by the EMA. And by the way, it just makes sense:

Understand and manage risks.

Maximize focus on quality.

We all get it. No one's arguing against it. But the reality is, the Biopharma industry has spent the last 10-15 years dipping their toes in these concepts, and not embracing them as the cultural forces that they should be.

Here is a common current state of RBQM:

• We focus on critical safety and efficacy data and make sure it is priority for monitoring and review.

• We have a (simple) "risk management plan" with regular risk review meetings.

• We have a lessons learned meeting at the end of our trials.

• We have really awesome excel sheets to help define and track our risks and quality management plan. (I am not knocking a good excel sheet by the way)

Here's the potential as I see it, and perhaps others see it:

• We have a comprehensive risk evaluation for each study based on key design parameters and best practices captured across all trials. We have Key Risk Indicators supporting each of our risk statements which are data-driven, assigned and actioned when needed.

• We have a robust risk database, categorized and searchable, that captures all of our risks and allows us to easily identify and plan for every new trial.

• Our risk management process includes continuous feedback and lessons learned that get incorporated into immediate action plans.

• We pre-identify ownership and action plans when KRIs are triggered or thresholds like Quality Tolerance Limits are met.

• We define Critical-to-Quality factors for every study, leveraging best practice standards outlined in our Quality Management database.

• Our software tools supporting RBQM deliver relevant just-in-time information including necessary KRIs to the study team.

• Our data review plan includes KRIs and data science driven algorithms that identify outliers and unanticipated trends.

It is true that the "dip our toes" model provides some benefits, e.g. helping to focus the team and being more proactive when it comes to study related challenges and risks. So what is the advantage of going all in on RBQM?

Culture: When everyone has been trained and involved with a robust RBQM process, it impacts how trialists approach problems as well as how they manage them. Have we done a systematic risk review based on our study design characteristics? Are we being data driven? Are our KRIs actionable? How can we instill best practices or lessons learned into our standard processes moving forward? Do I smell any smoke? ...when the study team has a mindset focused around risk and quality, better design and outcomes can result.

Efficiency: I'm busy, you're busy. Even the people we outsource to spend time on our trials have other things going on (no matter how much you pay them). If we're locked in on the key factors that will drive success as priority, that will help crowd out the less significant tasks or issues with lower impact. In fact, let's try to fully automate those less important tasks so we don't need to think about them!

Better outcomes: If you are thoughtful about the challenges and risks related to your study, let's say a primary efficacy assessment delivered remotely, then you can create a thoughtful and holistic mitigation plan e.g. comprehensive training + upcoming notifications + real-time dashboard visibility + risk-based monitoring triggers. This can result in maximizing the chance of successful completion of that remote primary efficacy assessment.

Let quality related risks drive your focus.

Use quality-driven risk indicators and flags to drive a more deliberate, actionable focus on what to care about, when. This isn't to say we should stop thinking, evaluating and smelling smoke on the fly, but why not reduce the firefighting and enhance the fire prevention?

Some examples:

1. Traditional: what’s the current enrollment rate for our study? How did it get so bad?

2. Risk-based: where are we in relation to our 20% per month enrollment expectation? Should we trigger our enrollment enhancement plan?

1. Traditional: how many participants have related or possibly related SAEs? That seems like a lot!

2. Risk-based: do >10% of participants have related or possibly related SAEs? What is the % breakdown per site? Let's initiate a call between the site and our Medical Monitor as discussed.

So how do we get started?

Here's an RBQM step-by-step process.

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