Guest Column | June 8, 2015

Risk-Based Monitoring: A More Strategic Approach To Site Monitoring And Clinical Data Management


The cost of running an effective clinical trial continues to rise. Trials have grown increasingly complex, causing new challenges for sponsors and CROs in clinical trial oversight. Companies are searching for ways to drive efficiency, improve data quality, lower costs, and cut timelines.  Site management and monitoring are two of the most costly components of clinical trials. The good news: Risk-Based Monitoring (RBM) is a more strategic approach to site monitoring and clinical data management that aims to allocate resources based on risk and need, as opposed to delegating resources equally. The approach can be carried out regardless of the unique demands and challenges of each site and team while still maintaining robust data oversight.

Industry groups like TransCelerate and regulatory agencies around the world are all advocating for more efficiency-driving tactics like RBM. Thus, more sponsors are considering adopting the approach — although there is quite a way to go before it is a universally accepted practice. However, we believe its adoption will continue to increase over the next several years as more research and case studies are completed with this method and best practices are defined and improved. 

Risk Based Monitoring: How It Works 

RBM refers to a variety of tactics, from reduced source verification to remote monitoring or centralized monitoring, aimed at strategically using resources to ensure the safety of patients and the integrity of data. In fact, sponsors may have used some of these methods before but not called it RBM. Communication is vital, and through the use of customized study-specific dashboards, cross functional teams are able to review data more effectively through this practice of real time data review. This approach can also help teams avoid redundant reviews and fosters collaboration across sites and teams. When team members work more efficiently, they have more time to focus on issues like safety, data integrity, and site performance.  

An RBM approach must be tailored to the individual trial. To determine if it could work for you, consider these steps:

  1. Engage all requisite departments and work together to create a monitoring and data management plan that defines and manages risks to clinical conduct and data quality.  Universal items of discussion, despite trial size or design, should include: risk and contingency planning, safety, efficacy, site performance, and data quality.     
  2. Read the FDA’s comprehensive guidance on implementing the approach.  The FDA guidance notes that RBM is not a “one size fits all” approach, but it provides examples and highlights the importance of good protocol and CRF design. It also highlights techniques and technology. Ultimately it is up to the sponsor to design a customized RBM approached based on multiple study specific factors. 
  3. Look at factors such as complexity of study design, safety of product, and study population. Is this a small Phase 1 study where risk is high in terms of impact on future clinical development, or a Phase 3 study where a risk-based approach might be easily implemented given clinical technologies utilized like Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), and Interactive Response Technologies? 

RBM should only be considered when the risks applicable to your study are well defined. Take time to assess the protocol for all risks: scientific, medical, regulatory, and/or operational.  

Choosing A Partner – Consideration For Risk Based Management Adoption

Most companies partner with a CRO or clinical technology vendor to help develop the plans and manage the process, technology, and data management solution. When choosing a partner, ask yourself the following questions about the technology the partner will bring to the table:

  1. Is the EDC database system flexible enough to allow for changes throughout the study?  (RBM is a flexible approach, so you’ll need a flexible system.)
  2. Does the system provide real-time information on how sites are performing?  Are you satisfied with the quality of data?
  3. How well does the data and the system integrate with existing technologies you’re using? 
  4. Would your staff be comfortable using this system?  Is the interface intuitive and simple?
  5. What are your reporting needs in terms of type and frequency? 
  6. An effective RBM solution will be simple to use, offer superior data management capabilities, and seamlessly integrate with your existing technologies, all while providing needed information on-demand to make decisions. 

If you do opt for an RBM approach, consider building in additional modes of site  communication, such as scheduled emails, phone calls, and more frequent newsletters, to compensate for sites who may feel less supported (as dictated by their level of risk and need determined by your monitoring plan). You’ll still need to visit all sites in-person; it’s just a matter of determining the frequency with which you need to be performing these visits. A continuous risk assessment based on risk indicators such as investigator inexperience, staff turnover, errors related to study endpoints (e.g., safety data), poor protocol adherence, failure to report adverse events, and delayed data entry are just some examples that can be used to determine the frequency of these visits. The frequency must not be fixed but continually assessed throughout the life cycle of the study.

Although more in the life science industry are beginning to discuss and even implement RBM, there is still some uncertainty surrounding the best way to proceed. A lack of understanding and familiarity with the FDA guidance plus lack of a clear risk plan may be stumbling blocks for implementing a RBM approach. A clearly defined protocol and clear study specific plans are early ways to overcoming these stumbling blocks. Risk Based Monitoring is intended to free up resources so your study team will have more time to focus on data integrity, adhering to protocol, and keeping patients safe. When conducted responsibly in partnership with relevant technology solutions, RBM can promote better decision making, improved efficiency, shorter timelines, and lower costs. It will take time and research before it is more broadly adopted, but you can be certain the industry will continue to study its effectiveness and develop best practices that will likely improve the approach even further. 

Risk based monitoring has certainly been a “hot topic” in 2015 and promises to drive more efficiency in our industry.  As a result, there are increasingly more frequent training opportunities, newly published RBM case studies for reference, and a wide variety of outsourcing opportunities.  The overall goal for clinical trials must be quality data and patient safety, and a well-designed risk based monitoring strategy undoubtedly supports this aim.