top of page

Why people really buy RBQM

I’m fascinated by the psychology involved in human decision making. There are hundreds of books and academic papers on the subject, but the key points they all seem to come back to are:

  1. People make decisions based on emotion, not logic (despite what they think, and what they’ll tell you) and the two primary emotional drivers are:

    1. Gain – wanting to get or win something; and

    2. Fear – fear of loss or missing out

  2. Once the decision is made, people will then use logic to justify their decision

I was thinking about this in relation to clinical trials. Specifically, why isn’t Risk-Based Quality Management (RBQM) being implemented in every clinical trial? The recent ACRO report highlighted low RBQM take-up across 6,500 trials. Granted, the survey was conducted pre-pandemic, and lots has changed since. But even an anecdotal poll of webinar attendees will show you that there is still far from universal adoption.

The “logical” reasons we’ve heard for not implementing a risk-based approach, some as recently as last week, include:

  • We don’t need to on early phase trials

  • Our customers don’t want it

  • We don’t need to

  • We’re not ready

  • I don’t have Senior Management buy-in

  • Force of habit

  • Trial team understanding the concept

  • Risk aversion

  • It’s time consuming

  • Proving the value of RBQM

When just reading the list ‘raw’, without having someone passionately trying to justify it to you, makes most of these reasons seem very weak. That implies that the ‘justification’ is used to cover up the real ‘emotional’ reason. And you don’t need the deduction skills of Sherlock Homes to work out that it’s not gain driving the decision not to implement RBQM, so it must be fear.

But fear of what? Fear of change is a very common human condition. Our ‘animal brains’ tell us keep safe, warm and avoid anything causing discomfort (or worse). That includes exposing ourselves to criticism or censure for proposing something new or different. Especially something that has the work “risk” in the title. Yet when people are honest with us about their underlying reasons for not wanting implement RBQM, more often than not, we can help.

That’s been particularly true with organizations that want to implement RBQM for ‘gain’ reasons. With Sponsors it is often giving them oversight of their CRO partners, or Sponsors wanting to take more activity ‘in-house’.

With CROs it’s often the desire to win more business over their competition. We’ve seen a trend where CRO’s we’ve helped implement RBQM are consistently winning over their rivals. So much so that the rivals are now coming to ‘chat’ about what RBQM might do for them.

And I would argue that the ‘logical justifications’ for implementing RBQM are both clear and compelling, including:

  • GCP compliance

  • Increased patient safety

  • Improved communication, collaboration, and engagement between Sponsors, CROs, and sites

  • Increased trial efficiency and focused used of valuable resources

  • Ability to handle increasing data volumes from new technologies and trial designs

  • Improved data quality and effective reporting, both during the trial and at the end

  • Increased corporate knowledge and learning applied to current and future trials

So if you’ve decided to implementing RBQM and have come up against ‘logical resistance’, or you’re still thinking about it, please get in touch and we can help you make the right decisions for your organization.


bottom of page