How Does Risk-based Monitoring Impact eSource for Clinical Trial Sites?
Photo credit: U.S. Food and Drug Administration
I will be on a great panel on risk-based monitoring and eSource methodologies at DIA June 16, and I want to highlight a few points from my presentation. If you want to learn more, I hope you will seek out the panel, and I hope to see you at DIA. In 2013, FDA issued guidance on risk-based monitoring that helped clear the way for new types of oversight for clinical trials. “FDA wishes to encourage more effective monitoring of clinical investigations, to ensure adequate protection of human subjects and the quality and integrity of clinical trials data,” the agency said in 2013. But risk-based monitoring monitoring can only catch on in the industry if all stakeholders are comfortable with the process. Why shift to risk-based monitoring when source data verification (SDV) – a method in which investigators cross-check case reports with original documents – has been the norm?
As we have discussed in the past, Medidata partnered with the industry group Transcelerate to assess SDV. Using data from more than 7,000 clinical trials, we found that only 1.1% of site-entered case report data are corrected as a result of SDV. Let’s say that again: SDV only caught errors in 1.1% of the data. The results were sufficient enough for Transcelerate, which is made up of members from many of the leading life sciences companies, to confirm the relative unimportance of SDV. So what does this all mean for eSource?
Essentially, eSource is a methodology to collect original data electronically. It’s a simple enough concept. This isn’t to be confused with collecting data on paper and then transferring it to a database. The benefits for eSource are substantial: 1) eSource eliminates the need for SDV because data can be checked automatically. 2) eSource reduces the need for onsite monitoring visits and allows for the focus of monitoring visits to be changed to improving site relationships. 3) Entering data directly into eSource facilitates remote monitoring of research sites and gives site monitors real-time access to study data. However, these benefits can be stripped away without proper eSource implementation. Site can be burdened by a dependence on multiple electronic data systems. One of the benefits of eSource is its ability to reduce burden on sites. Instead of having to enter data first on paper and then transfer to an electronic database, eSource goes directly from the investigator’s fingertips to the electronic database. But how many investigators want to navigate several different electronic data systems? Sites and sponsors can eliminate complexity by reducing the number of systems used by the investigator.
On a similar note, stakeholders must be sure to have a process in place to integrate clinical trial data collected via eSource with other patient data collected by the investigator. As new technology becomes available, sponsors and investigators will have to be able to manage new, disparate data sources. Without proper data management, novel approaches to collecting subject data will be wasted, and valuable insight will be buried in a haystack of noise.