Risk-based Monitoring: People, Process & Systems In Motion

Pharmaceutical companies and clinical research organizations (CROs) that adopt risk-based monitoring (RBM) in their clinical development programs often ask what a normal day or normal week will look like for the resources involved in the process.

Much like driving a car on new roads, you don’t necessarily know what is around the next bend, so you must constantly monitor your surroundings.

While FDA guidelines and new good clinical practice (GCP) guidance from ICH (International Conference on Harmonisation) give basic structure to RBM processes and methodologies, companies still have the ability to design their tools and dashboards with a wide variety of gadgets and monitors to help them anticipate potential risks.

Because of the flexibility to configure these technologies and interfaces, the new normal is hard to define before a full strategy has been implemented. However, there are important concepts that need to be considered when designing a strategic monitoring platform for clinical development programs.

In the automotive industry, designers innovate to provide the most effective tools for drivers to anticipate and react to oncoming risks. Everything from traffic signal recognition, to night vision and active lane assist alerts are now available to customers. When pharma companies implement RBM technologies, it’s common to see misaligned processes that don’t fully integrate with the technology’s functionality, which results in tools that unnecessarily lose some of their ability to provide advanced alerts and corrective action options.

Signals that don’t spawn action are a killer

I was recently in a conference room for a RBM workshop when we suddenly heard fire alarm triggered down the hall.

To me, nothing is more discrete in its signaling, purpose and intended action then a fire alarm. But how many times has a smoke detector gone off in your house and you went through the following progression of thoughts:

1.      Now, in the middle of House of Cards?
2.      The battery must be dead.
3.      Did I leave the oven on or is something burning on the stove?
4.      Is the iron on?
5.      Is Tommy playing with matches upstairs?

We typically don’t react as quickly as we’re meant to, but eventually we spring into action to investigate the source of what caused the alarm, which is the device’s sole intended purpose.

But why do we do this in the home, and not in the office? At home, you’re likely to own the structure, and your loved ones may be in harm’s way. Clearly, you’re invested, responsible and take action.

At the office, companies may assign fire captain duties to employees and work in conjunction with facilities management, security, or other departments to enact an evacuation plan. Most organizations define these plans, train colleagues, and actively test them throughout the year to measure their effectiveness.  

Back at the RBM workshop, a room full of PhDs, MBAs and seasoned clinical professionals sat in a conference room staring at each other as the alarm rang. Who was going to investigate if the alarm was real? Who will make the call for us to step out of this important meeting? One of the ways companies measure fire safety is by counting the minutes it takes to completely evacuate the building, and here we were wasting precious time instead of acting. So where was the breakdown?

There is a key lesson to be learned as pharmaceutical companies and CROs work to implement a robust RBM solution and strategy across their enterprise. From the preceding example, it wasn’t that (1) the proper signals weren’t in place, or (2) that people didn’t understand what a fire alarm meant; rather, (3) the process was lacking to lead people to act.

Most clinical studies have scenarios where a failure to act can significantly impact the health and well-being of subjects. It’s why we take adverse events and serious adverse event reporting so seriously, and it’s also why regulators have such strict guidelines around the turn-around timelines for reporting these events.  

We view RBM as a solution to a proactive approach to resolve issues, while reactive project management has always been known as a silent killer to the effectiveness of a clinical trial. Trust the signals and the process, allow the factors to guide the decision, and then don’t think, act.

People, Process, System

You likely hear, “People, Process, System” a lot, but might not always be able to articulate what it means to your business. The tenants of a holistic RBM approach rely heavily on these three assets to not only support and leverage the other’s strengths, but to combine and allow a proactive approach to drive a company’s business forward.

The key is to ensure that the three work in concert with each other, to focus on specific desired outcomes and measure those outcomes regularly to ensure you’re managing projects effectively, improving previous performance (when capable), and mitigating risks and/or delays. These are often called metrics, or key performance indicators (KPIs), but put simply, they’re potential indicators of failure or success, giving reason to investigate.

In the fire alarm example, KPIs can measure the success of the people-process-system dynamic for fire safety in a building:

• Time (in minutes) from initial alarm to 100% occupants confirmed as evacuated
• Number of fatalities from fire per year
• Number of injuries from fire per year

The first metric is the hardest to track. With any large building, you have to rely heavily on a group of individuals to report how long it took to evacuate, collect the disparate data sets, and then evaluate the data to capture the evacuation time metric. Most companies will schedule at least one false alarm a quarter to test their process, but well-trained organizations measure their performance during non-scheduled events, and this is where we can find areas to copy into RBM.

Do you have the right mixture of operational and clinical key risk indicators to give you a holistic evaluation of the process, with the right people, to get the desired outcomes?

A holistic RBM approach requires that alerts and signals tie to planned risks as well as unplanned risks. The best approach is to tie people, process and system together, so that no individual is left behind, and expectations and outcomes are clear, measurable, and can be improved upon over time.

[This article first appeared in Forbes MedidataVoice.]