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Jump the Shark – In a 1977 episode of Happy Days, the Milwaukee-based teens visited Hollywood. For the Fonz to “keep his cool,” he waterski jumped over a pen of sharks – an outrageous plotline that has been mocked ever since. Even though the show continued for another five years, its viewership started falling. We now use this idiom to describe technology that is “past its peak” suggesting an unwillingness to acknowledge signs of a decline.

In the clinical trial industry, many believed risk-based monitoring (RBM), a dynamic strategy where a monitor’s activities are modified based on pre-agreed parameters, had the potential to deliver the most significant impact on improving the quality of patient safety and study data.

RBM involves a combination of on-site monitoring, remote or centralized monitoring, yet as companies began adopting this strategy, they found the process arduous and have reduced the scope of the process. So, we have to ask: Has RBM jumped the shark?

We believe it has, although a streamlined version of RBM and Targeted Source Data Verification (SDV) — should survive the jump. Here’s why.

The Early Days of Risk-Based Monitoring

Six years ago, TranCelerate BioPharma Inc., a nonprofit striving to improve people’s health through innovative therapies, embraced RBM. Three years later, the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) released E6 (R2) that stated sponsors were required to implement a system to manage quality throughout all stages of the clinical process.

TranCelerate reported that not only could RBM improve the quality of patient safety and study data, but it could reduce monitoring visits by 25%. Monitoring is the most expensive part of the clinical trial, so using a system that could reduce that spend and increase the quality of the data seemed to be a win-win scenario. As a result, several vendors and consulting companies developed solutions, and big pharma began to conduct pilot studies. The race was on for less expensive, better-managed trials.

Determining KPI and KRI

RBM was a new discipline that few organizations had in-house. Instead, a new skill set and software were needed to initiate the program. The desire to introduce this new concept led to comprehensive consulting engagements. Companies had to determine their Key Performance Indicators (KPI) and Key Risk Indicators (KRI.) The quality management principles of risk-based monitoring were centered on conducting a risk assessment, monitoring risks, and mitigating risks as issues arose.

The goal of risk-based monitoring was early detection of issues and proactive risk management. However, different studies involve different visit structures and site requirements. Therefore, the makeup of the KPI and KRI were different for each indication. Most of these KRIs could be translated into activity within the EDC system to yield scores, but some risks needed to be captured outside the EDC and measured along with operational data. These scores formed thresholds for certain risk indicators that corresponded to mild, moderate or severe risk for that indicator. The scoring methodology would be written in a Monitoring Plan and Clinical Operations would enter the study knowing exactly how they were going to deal with their site’s performance.

Too Much Work for Many Organizations

It soon became clear that the level of effort for a true RBM program was beyond the resources and talents of many organizations as originally conceptualized. The consulting effort often required outside talent or dedicated individuals. The formation and translation of the indicators into an EDC system and Monitoring Plan have proved to be expensive and time-consuming. It was also determined that the effort to form an RBM strategy usually had to begin two months before the study build. RBM received mixed results and timelines for study starts did not decrease. What looked like the next big thing in clinical trials fizzled as companies pivoted to reporting software for metrics.

Targeted Source Data Verification is Sticking Around

One component of RBM that is sticking is Targeted Source Data Verification (SDV), which normally calls for 100% verification of the data associated with safety and endpoints, and less time is focused on the remaining collected data points. A Targeted SDV plan leverages the eClinical platforms to configure flexible, but standard targeted algorithms. This allows more groups to reduce monitoring costs, or at least focus their monitoring spend where it adds more value. Meanwhile, the ever-improving real-time data checks continue to collect the cleanest initial data. And both analytics tools and centralized roles fill in the additional review.

So, yes, RBM has jumped the shark. The upfront time and money to make analytics software manage a monitoring plan was too great of an effort. What is evolving from this effort is a streamlined version of RBM, an RBM Light, that will utilize more standard KPIs and KRIs from reporting software that can be delivered with a menu type of delivery. Combined with the use of Targeted SDV, most of RBM Light can be programmatic and a high-value component of Clinical Operations. So, although RBM itself jumped the shark, RBM Light will continue to swim.