RBM has its own track this year’s Clinical Research & Operations Worldwide (CROWN) Congress in Philadelphia, which Outsourching-Pharma.com attended.
In the first talk of the afternoon RBM session, Sina Djali, Head, Risk Management – Central Monitoring, Integrated Data Analytics and Reporting, Global Clinical Development Operations, Janssen R&D, opened the conversation by commenting on the increased consensus that RBM is the way of the future.
“We stopped crawling, we’re starting to walk,” said Djali. “In five to ten years we’ll be running marathons all the time, continually.”
This is in part driven by new regulations which will make RBM a necessity (the ICH E6 addendum is scheduled for November 2016). According to the FDA, “Since the development of the ICH GCP Guideline, the scale, complexity, and cost of clinical 22 trials have increased” – which is one of the reasons an addendum is needed.
Additionally, the administration added, “Evolutions in technology and risk management processes offer new opportunities to increase efficiency and focus on relevant activities.”
The quality management addendum (5.0) calls for critical process and data identification as well as risk identification, evaluation, control, communication, review, and reporting
“The sponsor should implement a system to manage quality throughout the design, conduct, recording, evaluation, reporting and archiving of clinical trials,” it added.
“Instead of risk based monitoring being a fashion, it’s part of our regulations,” said Andy Lawton Global Head, Clinical Data Management, Boehringer Ingelheim, during his session at CROWN Congress today.
“Tolerance limits are essential to establish,” he explained. “It’s the way of the future.”
A mind shift
RBM requires a mind shift from an execution perspective, and many are nervous about the required implementation and what it means for the industry.
Mainly, what it means and what will happen if pre-set requirements aren’t met.
“We have to react and think about it,” added Lawton, explaining that the inspectors are also nervous.
Lawton asked the audience to think of the pharma industry as a manufacturing process: if it was, it would be akin to taking raw material from 500 suppliers for its submissions – think Apple making iPads with 500 different sets of screens from around the world.
“That’s what we do in clinical trials,” he explained. “We have to find a way to have better control of the raw data production.”
This control is what regulators are seeking: a transparent quality assessment, up front and in the end to see if standards have been met.
However, Lawton said that “it’s not that much work,” as much of it should be happening already.
“If we don’t know what the variation is going to be with the primary end point, then we’re in trouble,” he added.
Yet, there will be flexibility in changing tolerances as trials advance, but these changes need to be explained.
“We have to think more about what’s happening in clinical trials and be able to explain,” said Lawton.
Establishing tolerance limits also pre-establishes what Lawton calls “knowledge management systems,” and also means that companies will have compliance met at entry.
This management system uses metrics at every step, which is critical to RBM and also allows for better integration at the various steps of a clinical trial.
“In the pharma industry we are far too silo based,” said Lawton. “And that’s recognized by the regulators.” It was one of the key points of having integrated assessment
However, according to Lawton, RBM is about understanding and controlling risk – it doesn’t mean taking risk.
“We aren’t taking risk with our clinical data,” he added. “You have to understand risk. Risks are not issues.”
Using an apt metaphor, considering the current weather in Philadelphia with Jonas, Lawton explained that just because it was icy over the weekend, it didn’t mean you were going to have a car crash, understanding the risk means that we adapt to the more problematic conditions.
“You take account of the situation and you adapt accordingly.”