Risk.Based.Almost two years to the day, TransCelerate released their first position paper on risk-based monitoring. TransCelerate also released an accompanying tool called the RACT which helps guide companies in their adoption/usage of risk-based monitoring. 

The industry had been eagerly awaiting this paper ever since the risk-based monitoring workstream was announced as one of the five initial goals of the TransCelerate collaboration. A few months later, the Food and Drug Administration (FDA) released a guidance for the industry on how to leverage risk-based monitoring. 

Despite all of these guidances and references on how risk-based monitoring can be useful in helping to ensure that we monitor/analyze the important components of a site's execution of a trial, we have yet to see many enterprise-wide implementations of risk-based monitoring.

Why, if the industry is yearning for risk-based monitoring, have we not seen more implementation?

3 Reasons RBM is not as wide-spread as we would hope:

Nobody wants to be the first kid in the water!

Until a company has been inspected by a regulatory authority and  given the nod for its use of risk-based monitoring methodologies, many companies will hesitate to implement RBM as anything beyond a pilot initiative. When clinical and compliance teams do not have precedence to rely upon to support something novel and new, they will often favor the conservative approach which entails doing things the way they have been done in the past.

Data is everywhere, but not where we need it!

Since companies are always implementing/upgrading eClinical systems it is hard to create a static picture for where the data required to support risk-based monitoring is being stored. If a company is lucky enough to identify the sources of all the data, it is necessary to aggregate that data for reporting purposes and this is not a trivial activity. Companies need assistance on pulling this data together and it seems that too many vendors have a solution called "just buy our entire eClinical suite and you will be set." Life Sciences companies need real support from vendors and system integrators to leverage their existing data sources which are already embedded in their processes and eClinical landscapes.

risk.management.goalsOperating models take time to redefine.

Due to the nature of how clinical trials have been run over the past decades life sciences companies have become very good at defining what their organizational structure needs to be and how they can integrate CRO partners into their operations. Risk-based monitoring throws a wrench into this machinery because it places less emphasis on source data verification and more on data analysis. This requires that organizations evaluate what they need from a human resources and business process perspective. People may be asked to do new things or there may be the need to create entirely new organizations and roles. Additionally, Sponsors need to re-visit their operating model in terms of monitoring and oversight and long-term contracts can serve as an impediment.

While the first challenge requires someone to test the water and be validated by the regulatory authorities for taking advantage of a new way or working with sites, the other two issues are easily solved. They require analysis of current state systems and processes and then working within a framework to define the future state. 

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