Cutting the price tag of clinical trials with risk-based monitoring

Rick Morrison

Comprehend Systems

In our R&amp,D innovation focus month, Rick Morrison presents the cost benefits to pharma associated with risk-based monitoring.

On-site monitoring is a significant expense for pharmaceutical and biotech sponsors, accounting for up to 30 percent of the cost of a clinical trial. An extremely time-consuming and costly process, traditional site monitoring requires thousands of man hours that sponsors and CROs simply don’t have to spare. A more centralized, risk-based approach can reduce the price tag of site monitoring and is actually more effective and safer for patients, because more focused data means better accuracy. In fact, the FDA has shifted its guidance over the last couple of years to encourage risk-based monitoring rather than full on-site monitoring. It’s also been made possible by the widespread utilization of electronic data capture (EDC) systems, enabling remote monitoring of trial data and faster decision-making to effectively deploy resources as risks are identified.

Cheaper and safer? Sounds too good to be true…

A strategy to reduce resources and improve safety may sound too good to be true, but there is strong reasoning for the impact of risk-based monitoring on improving clinical trials. The tedious process of full on-site monitoring leads to issues with accuracy and effectiveness. It’s just not possible to wade through that much data, so monitors end up skimming the information, meaning that problems with the trial can easily go unnoticed. Alternatively, evidence suggests a centralized, risk-based approach is better able to detect data anomalies, including fraud, fabrication of data and other disruptions. Because the approach is more targeted, those responsible for site monitoring have a higher level of accuracy.

The modern analytic tools and technologies used in centralized, risk-based monitoring practices enable powerful insights into the data so that resources can be used more efficiently. Because data monitoring can be accomplished remotely, sponsors can significantly cut back on the man hours needed. With risk-based monitoring, rules-based trigger factors – like quality or enrollment data anomalies – can be deployed to indicate what process needs to be conducted to best use the resources at hand. While this sometimes means issuing an on-site visit, it’s a drastic reduction from 100 percent on-site monitoring. Over time, sponsors can build up a library of alerts which eventually evolves to become “intelligent,” proactively identifying and alerting monitors of problems in clinical trials.


“We can expect to see continuous innovation as this approach becomes the industry standard.”


What sponsors should consider before deploying risk-based monitoring

Sponsors and CROs need to invest in data platforms that support quick, easy and centralized reviews of trial results as data comes in. The right people should have secure access to data at the right time, and the user should then have the ability to interact with the data without the need for programming knowledge. The person responsible for the site monitoring should be able to drill down into the data and easily and quickly respond. Of course, the information delivered should be quality, accurate data.

Any sponsor should make the appropriate considerations when making the migration to risk-based monitoring to defend results to regulatory bodies. Sophisticated trigger tools that accurately identify errors throughout the trial must be in place. If the triggers aren’t executed properly, it could sacrifice the entire study. Excel spreadsheets sorted on a weekly basis aren’t going to cut it. To successfully deploy risk-based monitoring, sponsors are going to need analytics programs integrated across all systems. The alerting system must be automated and have the capacity to handle hundreds of triggers.

But risk-based monitoring is not a one-size-fits-all approach. There are certain studies that may not be appropriate for centralized monitoring practices. High complexity, high risk, large or geographically widespread studies may need more on-site visits to ensure compliance and correctness. In those cases, sponsors should be cautious when deploying risk-based monitoring, but may be able to rely on it if the right technology infrastructure is in place. These studies must have sophisticated EDC systems, accessible audit trials and metrics, advanced analytic tools and access across EDC, patient enrollment, CTMS and safety systems.


“Driven by sophisticated analytics platforms, a centralized, risk-based approach will enable clinical trials to be more quickly, safely and affordably executed.”


We’re just getting started

Risk-based monitoring is an exciting opportunity in clinical development that is sure to evolve as more and more technologies are developed to address the change. We can expect to see continuous innovation as this approach becomes the industry standard. In the not-so-distant future, sponsors will be able to take advantage of off-the-shelf packages and large libraries of pre-made triggers so they can instantly get started with risk-based monitoring. These advances lead to an evolution of best practices and improve the effectiveness and ease of risk-based monitoring. Eventually, even regulatory bodies will be able to use risk-based monitoring.

Full on-site monitoring is quickly becoming a thing of the past. Risk-based monitoring has proven to be safer and more effective, and will become increasingly commonplace across the pharma industry in coming years. Technology is facilitating this trend to make studies as safe and cost effective as possible. Driven by sophisticated analytics platforms, a centralized, risk-based approach will enable clinical trials to be more quickly, safely and affordably executed. Because risk-based monitoring makes better use of study resources and increases study success rates while decreasing the costs, this approach will become much more prevalent in clinical trials in the coming years.


About the author:

Rick Morrison is founder and CEO at Comprehend Systems, where he is responsible for the overall direction and management of the company. In 2012, Rick was named to the PharmaVOICE 100, which recognizes the 100 most influential people in the life sciences industry. Prior to Comprehend Systems, Rick spent nearly a decade developing clinical analytics tools, including tools used by the FDA and top pharmaceutical companies. Rick holds a bachelor’s degree in Computer Science from Carnegie Mellon University.

What benefits does risk-based monitoring bring?