It’s a no brainer that applied metrics are invaluable for more accurately projecting patient recruitment; however, many people assume that once a trial is underway, it’s no longer necessary to measure anything until all the study data are accumulated. That’s just not true. There is tremendous value in the ongoing application of metrics, throughout the entire study cycle, so much so that we sometimes find it hard to imagine how anyone can conduct a successful study without metrics. But we’re not talking about numbers for numbers’ sake. It takes a great deal of expertise to know which measurements to take and how to interpret the findings.
In the past, information was generally gathered during a study. Everything was paper based. Most data exchanges depended on phone calls and faxes, which were both time consuming and prone to error. Sponsors relied on each site’s self-reporting, which might be intermittent, anecdotal, or biased. It was nearly impossible to identify a patient recruitment problem at a site unless someone at the site identified it. And even when an issue was identified, the staff might not ask for help. Outreach efforts often failed to reach the target audience, but no one knew why. Assorted systems and methods captured bits and pieces of study information, but there was no central repository and no way to get an overall picture of a study in real-time.
BBK recognized that valuable knowledge was out there. It just wasn’t accessible. Simply put, BBK saw the need to create a window into each study as it was unfolding; a system that would generate data to support effective decision making and ensure that study resources were being optimally deployed. When we started to look at what such a system would need, the wish list turned out to be a long one, encompassing these elements:
- Timely access to enrollment data, from point of contact through study completion
- Support for study community communications
- A repository and document management system for study materials
- Compatibility with all operating systems
- Accessibie to all members of the study community
- Easy to use
- Internationally customizable options
- Compliant with HIPAA and Safe Harbor Laws
Since nothing on the market answered all of these demands, BBK created TrialCentralNet (TCN®), essentially a patient recruitment management system. TCN imports data collected from all study databases and resources (like IVRS, EDC systems, etc.) and consolidates all that information into one portal in addition to recruitment and retention metrics. With all of these metrics, sponsors are able to have real-time quantitative proof of what’s working, where it’s working, and with whom it’s working. Real-time data carefully collected and analyzed from a pilot program can provide information to reshape full trial implementation. Furthermore, data from full implementation can be evaluated with an eye toward future trials.
If you'd like to learn more about BBK's patient recruitment management system, click here.