Where Are We Headed With Risk-Based Monitoring?

By Ed Miseta, Chief Editor, Clinical Leader

Craig Wozniak, Head, Americas Clinical Operations for GSK, is no stranger to risk-based monitoring. He has spoken on the topic on numerous occasions and has been involved with the risk-based monitoring initiative for TransCelerate since its inception. Recently he moderated a panel discussion on RBM: The Site Effect After Year One at the 2014 Site Solutions Summit sponsored by the Society for Clinical Research Sites (SCRS).

“At last year’s conference we talked about evolving monitoring practices, which has now become known as risk-based monitoring,” notes Wozniak. “SCRS has been active and produced some articles from that discussion, and we felt it was time to see where everything currently stands.”

Monitoring practices are certainly evolving, as are the quality control techniques being used. Quality by Design (QbD) is now being implemented into planning and execution activities as well. “Risk-based monitoring is the collective term that is referring to these changes and the approach being used,” says Wozniak. “It is important to note RBM is not about taking on more risk. It is about focusing on risks of a particular study, defining mitigations and actively managing them with the best techniques available.”

Sites Continue To Face Challenges

Craig Wozniak, Head, Americas Clinical Operations, GSK

The sites conducting trials are faced with a various challenges including working with multiple sponsors, processes, quality expectations, rising costs, personnel, and a myriad of local issues. At the same time interactions with sponsors have required sites to undertake more discussions and rethink their partnering strategies. “One of the things we wanted to do was to create awareness,” notes Wozniak. “We discussed the challenges sites face to find out where we are in this evolution. We also discussed how we can implement new monitoring practices under the banner of RBM. This is a great opportunity for sponsors to dialogue with a large group of site professionals. The people here at the SCRS Summit are investing time to understand what is going on in the industry, what the latest best practices are, and how those practices can be implemented at their own sites so they can be assured they are performing quality work.” 

One of the topics of discussion was centered on what is RBM. Wozniak notes the letters do not translate the same way for everyone. Other topics the panel will addressed were how monitoring is evolving, what trends are occurring in the industry, and the sharing of experiences across sites.   

Implementing RBM

The foundational elements of RBM are risk assessment and risk management. That entails having a formalized process where you look at a study at the sponsor, CRO, or site level and identify the key risks and mitigation opportunities. Those are the areas in which sponsors and site personnel need to focus during the study. When done correctly, Wozniak believes actions should resemble a closed-loop system of risk identification, mitigation, tracking, and resolution. “That closed loop system helps to create a focus on where we apply our resources,” he notes. “It can be on data critical processes, personnel, subject safety, or any other factor which will vary from site to site and study to study.”  

One area that is quickly evolving is the monitoring process and quality controls techniques. Wozniak notes sponsors have always conducted onsite monitoring of data. However, with technology now making that data available in real time, sponsors are doing more off-site or central monitoring. Information that is available in systems can be used to evaluate the process without having to go on site. “We now have the capability to do things differently taking a more holistic approach to quality,” states Wozniak. “That enables us to assess things such as how the trial is running and how well a site is performing.”

There are several other areas where sponsors are seeing dramatic change. One is the use of analytics to evaluate site activity and performance. Sponsors use these analytics to better understand which sites are performing well and identify the ones that may need some help.

Wozniak notes another advancement is using sampling techniques to evaluate process. “For example, we are moving away from 100% data verification,” he says. “Instead of checking all of the details, we are now checking the process through sampling techniques which will identify where there are systematic issues including if there is need to expand the sample.”

Greater Communication Is Necessary

The advent of central monitoring means that more of the conversations between sponsors and sites will be done remotely. Everyone in this industry knows that when you have a question, it is important for someone knowledgeable to be there to pick up the phone. “The communications should be timelier as issues are identified in stream and I believe we will see the focus and impact of those conversations improve over time creating efficiencies for everyone,” he states. “We will have to be flexible considering real life considerations of investigators and site staff in terms of scheduling.”

Wozniak believes communication is what will continue to advance new and improved risk-based approaches. “People will always be concerned about change, especially if they don’t fully understand what is happening,” he says. “How we monitor trials and the systems we use have never been consistent. That creates additional challenges for the sites, and RBM initiatives are not necessarily going to change that. That makes it even more important for sponsors to engage with the sites to make sure everyone is on the same page. Everyone needs to understand what are the deliverables, what are the priorities of the trial, and what are the key systems, processes, risks, costs, and effort required. We all need to understand that to ensure sites can properly perform their work and not face any surprises.”

In closing, Wozniak notes the opportunity for the industry to collectively improve the conduct of research has never been greater, and the concepts and approaches of RBM provide a next step along that journey. “We are all playing on the same team and working together to bring life-saving medicines to patients. This focus of these RBM initiatives is to do it in the safest and most effective manner possible.”

For more information on SCRS click here.