RBM: innovation or just common sense?

The article covers the topics of clinical trial budgeting when applying the risk-based monitoring (RBM) model. The problem is that the new monitoring model requires a new model of clinical trial budgeting too, while today, the common practice is to apply traditional fixed-price budgeting.

As Lynn King, senior director, Clinical Operations, TKL Research says,

“Risk-Based Monitoring (RBM) is one solution to combat the continually rising costs of conducting effective clinical research.”

Her previous article in Clinical Leader [1] certainly deserves attention and contains many astute observations. However, one of her ideas I cannot accept. Unfortunately, Lynn like many others believes that RBM is a cost reduction strategy.

No, no and no again! RBM is a strategy for speeding up clinical trials, but not for lowering their costs.

RBM: innovation or just common sense?

I am not entirely on my own in arguing this case. The RBM Consortium is a transnational alliance of experts from the quality risk management industry, risk-based technology firms, data analysts and biopharmaceutical business strategists.

Last year, in the journal Applied Clinical Trials they published answers to the 10 most burning questions about risk assessment and management in clinical trials [2].

The experts generally concluded that, “currently there’s no trustworthy evidence that any RBM approach has saved a substantial amount of money, however, one or the other company claim some petty savings. We are convinced that the implementation of a risk-based approach to managing clinical trials… will lead to clinical trials actually ending on time and on budget as planned.”

On time and on budget – the true goal of RBM!

It’s easy to understand why so many talented professionals are mistakenly looking for cost savings, rather than time savings.

As we all know, roughly 30% of an average clinical study’s budget now supports monitoring (that means visits). The fewer the visits, the lower the costs. But the basic RBM idea is basic common sense: you only need to monitor what really needs to be monitored. The better the site, the less close monitoring you need. The better the site, the fewer the visits.
In reality, surprises happen, as we all know. In theory, theory and practice are the same. In practice, they are “two different things”. However, even when making our budgets with an RBM mindset, in the end we usually have only one amount, which typically corresponds to the best scenario. But events rarely develop according to the most favorable plot – not only in our industry, but in general. Such is life. However, now the question is not about that.
And thus the tender is over (as a rule the lowest budget wins among all those submitted), things are moving, the trial is started up, and oops! It happens. An unexpected (in quotes) event exactly such an adverse event in CT. Why in quotes? Because everybody suspected it, maybe even warned about it, but turned a blind eye to it. Plus our traditional Russian trusting to luck. As we all know it leads to worse in future. And then the firefighting begins. Like in the program “Vremya” in summertime brave fire-fighters are battling forest fires. This working pattern is well known, so no need to give examples. Although we are seemingly not firefighters.

So, in the course of the project unforeseen circumstances arise, and it’s necessary to change the order. Again it causes endless coordination, discussions, and negotiations. And the trial begins to stall and may even stop for a while. Anyway, the project begins to fall behind schedule.

Cost of risk

A far better approach is to take a reality check and conduct a preliminary assessment of ALL risks. Simple technology – evaluate risks, set triggers, and plan risk mitigation tactics.

Today there are fully developed both methodology [3] and affordable “cloud” instruments [4].

The problem is that we don’t know how much it will cost to extinguish possible fires, and how much money we need to reserve in the annual budget “just in case”. But in our situation we know what cases can occur, what should be done and how much it will cost – accurate to a penny.

The most important thing is that you will not fall behind the project schedule plan. No need to reschedule as we do not waste a second. Like in movies, there is a short call to a sponsor, “We have a situation “four”. In reply, “Act on plan B”. And all know exactly what to do and how much to weigh in grams. The drug will be registered on time!

Revolution again?

Not at all! None of this is revolutionary or radical thinking. It’s just common sense that’s not commonly followed. As my favorite

As my favorite Jack Trout said, most managers often leave their common sense in the parking lot together with the automobile.

When you have a variable part of the budget, a full “firewater pond”, and nearby on the fire point stand – axes, buckets, shovels, and hooks, you don’t have to be afraid of any fires. You are simply ready for them. Forewarned is forearmed.

All I want to say is that our industry needs to stop looking at RBM as a way to save money and instead recognize it as a highly effective way to save time and reduce the term of the drug launch.

The only catch is the corporate rules and regulations that do not allow the luxury of the reserve part of the budget. And not all countries can afford a “gold reserve”, not to mention the rather thin wallets of our national producers. Risk-based monitoring requires risk-based budgeting (RBB).

Are our esteemed sponsors ready for such innovations?

References:

Risk-Based Monitoring: Understanding the Future Of Clinical Trial Monitoring. By Lynn King, senior director, clinical operations, TKL Research. Clinical Leader, July 2015.
RbM Guidance Document: Ten Burning Questions about Risk-Based Study Management. By Moe Alsumidaie, Beat Widler, PhD, Johanna Schenk, MD, PhD, Peter Schiemann, PhD, Artem Andrianov, PhD, Maria Proupin-Perez, PhD. Applied Clinical Trials, January 2015.
TransCelerate BioPharma. Risk-Based Monitoring.
https://cyntegrity.com/products/clinical-trials-with-earlybird/