Although risk-based monitoring (RBM) has been a hot topic for several years, the looming deadline for the ICH E6 (R2) addendum has significantly intensified our industry’s focus on this sometimes confusing topic. ICH E6 R2 outlines expectations more clearly than ever before: sponsors must now “develop a systematic, prioritized, risk-based approach to monitoring clinical trials” (5.18.3). In turn, pharma companies, both large and small, are preparing to implement this significant shift in methodology. RBM is now a priority for everyone. 

Considering the urgency, it can be tempting for companies to jump in immediately and attempt to tackle some of RBM’s big ticket issues (e.g., procurement of a technology solution to aid with risk management and tracking, establishment of a central monitoring capability). However, there is a very strong argument for taking a step back and first focusing on some of the softer elements of implementation; most specifically, companies willing to invest in robust stakeholder engagement and proactive employee education will reap dividends.

Stakeholder identification is a phase of project planning that is easy to shortchange; but in truth, it is one of the most crucial elements of a successful implementation initiative. A healthy RBM platform has the potential to touch a wide variety of functional areas, which may or may not be aligned with regard to initial expectations and an understanding of this relatively new methodology. Taking the time to systematically identify and prioritize stakeholders is an invaluable and eye opening first step for pharma companies. Once stakeholders have been identified, it provides the opportunity to align on vision and secure the appropriate sponsorship. It also creates a platform on which to build a comprehensive communication plan. 

Perhaps most importantly, the need for stakeholder engagement never really goes away. As RBM continues to evolve, pharma companies are just beginning to appreciate the possibilities. The technological landscape is changing so fast that an implementation initiative’s initial objectives can easily shift or expand. Not only should existing stakeholders be continuously kept up to speed; but new stakeholders may have to be added to appropriately reflect a refined set of objectives. Ultimately, the ability to establish strong linkages with all of these stakeholders, both existing and new, can make or break an RBM implementation effort.

Identifying key stakeholders is only the first step: Proactive employee education is another way pharma companies can set themselves up for success. First, it is critical to understand that RBM is an entirely new way of doing business, an absolute paradigm shift for our industry that is frequently compared to the jump to EDC (Electronic Data Capture). A change of this magnitude requires savvy stakeholders who are well versed in RBM terminology and process… but this will not magically happen on its own. 

As mentioned above, RBM stakeholders will originate from many different functional areas, and each will have their own set of unique expectations and assumptions regarding the pending change. Some will be quite familiar with the RBM space; for others, concepts such as Key Risk Indicators, Central Monitoring and Quality by Design will be totally new territory. This potentially wide range in user experience is further complicated by the variety with which RBM can be implemented (e.g., remote versus on site monitoring, installation of a central monitoring team versus adoption of a technology solution that can be leveraged across existing function areas). All of this variability can cause internal confusion and ultimately derail an implementation effort.

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In turn, pharma companies must find a way to level set. Consider the consequences if a project team is tasked with mapping out an organization’s RBM process, but the members are not all familiar with RBM basics or up-to-date on current industry guidance. Instead, companies should start educating key stakeholders as early as possible. A standard “road show” can be utilized to communicate an organization’s RBM vision and what it means for individual functional areas and contributors. However, there is tremendous value to going a step further and reviewing fundamental RBM concepts as soon as implementation team members are on board to ensure the team is speaking the same language before they start formulating solutions. The companies that successfully raise their organization’s RBM IQ are putting money in the bank.

In summary, ICH E6 R2 has increased the attention on RBM and accelerated many pharma companies’ paths toward implementation. As organizations prepare to move toward RBM, the true complexity of the task at hand may not be fully appreciated. Some common pitfalls can easily disrupt the evolutionary process: stakeholder disengagement and inexperience, as well as early confusion with regard to standard RBM process and the organization’s vision. However, with a thoughtful emphasis on some of the softer elements of implementation planning (like stakeholder engagement and early employee education), pharma companies can skillfully navigate the challenges.