Three Questions: Ashok Ghone, MakroCare USA
CWWeekly presents this feature as a way to put the spotlight on issues faced by executives in the clinical trials space. Ashok Ghone, Ph.D., is vice president of global services at MakroCare USA in New Jersey.
Q: Can you briefly explain the reasons why centralized monitoring is becoming an attractive alternative approach to traditional clinical trial monitoring, given that only a few sponsors have implemented it while others are waiting to gain more confidence in the process?
A: Traditional ways of conducting frequent monitoring visits are every four to eight weeks at investigational sites and 100% source data verification. However, they do not necessarily result in higher data quality, better monitoring of patient safety, or in an understanding of the critical issues early on in the process. So, there was a need to look into alternative, intelligent and smarter ways to achieve improved data quality and patient safety in a cost-effective manner.
The centralized monitoring appears to be the most suitable approach available today. This newer approach can provide many of the capabilities of on-site monitoring, as well as additional capabilities. With the use of technology like electronic data capture and analytics tools, it is easy to look at the data centrally or remotely to identify risk/issues in real time basis and take proactive or timely actions.
There are a couple of reasons why the industry is slowly adopting this approach.
Centralized monitoring is a new approach to clinical trial management. It needs change management in terms of process restructuring, people alignment, training and technology requirement. Therefore, the adoption is slow, as sometimes people are fearful of change management. It also requires internal process change, new SOPs/documentation development, getting the right technology in place and, at the same time, looking into developing new roles like central monitors. As this is a very regulated industry, it takes time to adopt any new change. Take EDC, for example. The industry has taken a good amount of time to convert from paper to electronic data capture and still we see some trials are being conducted using paper.
Another reason may be that people are worried about their jobs. Monitors/CRAs feel that there will be less monitoring for them, or some of them will not have work. However, we need to understand that while on-site monitoring visits will be reduced and monitors will have less on-site work, it opens new avenues for CRAs to get into new roles of central monitors with proper training. Now the industry will need these new roles.
The key benefits of centralized monitoring are how it helps improve data quality with better efficiencies. Most big companies have started implementing this approach into practice. Some of them are still running pilots to thoroughly gain more confidence in the process before fully implementing it into practice and across their studies. Running pilots takes time.
Q: While the FDA encourages sponsors to consider changing their approach to monitoring, why are some large companies hesitant to implement centralized monitoring?
A: It depends on the culture of organizations’ willingness to take risks and to go for change management to reap the benefits. Centralized monitoring requires a positive internal culture and senior management involvement to drive change management to implement the newer approach. So it really varies from company to company.
But a good number of large companies are running the pilots and some have already adopted centralized monitoring into practice as a part of their risk-based monitoring. As clinical trials are getting expensive, they want to validate the process completely, get full confidence, before they implement it to all studies in the practice. Some companies are working with their CRO partner or specialized service provider to implement it.
Q: Given that on-site monitoring accounts for one-third of the overall costs of clinical trial management, how does centralized monitoring minimize on-site visits by identifying risk/issues that improve the effectiveness of CRAs and save sponsors’ money?
A: Many aspects of onsite monitoring can be accomplished by centralized monitoring and it offers a proactive approach to identify risks/issues early on and thereby helps in planning and triggering site contact/visit based on the observed critical risks/issues. With this approach, we do not have to carry out routine monitoring visits every four to eight weeks to sites.
Based on site performances, one can optimize on-site monitoring visits and the time that monitors spend at the site. As monitors know the status of their sites, in terms of issues and risks through centralized monitoring, they can be more focused during on-site monitoring and use their time effectively.
As for direct savings, it comes from the reduction in the number of monitored site visits, reduction in monitors’ time at the site and travel costs. These changes will translate into significant savings—especially if the sponsor is working on a study with many sites and long duration.
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This article was reprinted from Volume 19, Issue 38, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »