Challenge and Background

Monitoring study progress and safety of subjects are critical factors to a study’s success. The most effective way to stay informed of the current status of these factors is to utilize a constant mid-study monitoring process. Even with the use of electronic data capture, mid-study monitoring has generally been limited to preset summaries or reports, or exporting data external programs to be analyzed. Alternately, for an additional cost, most EDC providers will add a report, but historically, mid-study monitoring has been very limited. Ideally, since data is collected electronically, the system should allow for the development of custom reports that fit the study’s needs as it progresses.

One challenge with setting up report parameters at the beginning of a study is that it is difficult to determine in advance every detail a report may need to output. As study data is collected and analyzed mid-study, the information that is most valuable to include in the reports for regular monitoring becomes more apparent.

Proposal

Prelude proposed the study use VISION™, an electronic data collection system, which already provides users with the ability to create an unlimited number of customizable searches and reports to fit study needs. Additionally, VISION™ already provides standard summaries and the data is available for continuous customizable export by designated users.

Solution

Prelude staff trained study staff to use VISION™ as the electronic data collection system and to utilize the system’s reporting functionality. Specifically, study staff was trained to perform searches to filter data, create ad-hoc reports, and share reports and searches with each other. They were also trained to copy reports into a spreadsheet and print as a PDF in order to share it with users outside the system.

Results & Benefits

Once trained, study staff was impressed with the system’s functionality and ease of use for creating and sharing searches and reports. During one of the trainings, as the trainer demonstrated how to put a report into a spreadsheet, one of the trainees asked the trainer to please do it again, then commented, “I had to see you do that again. It just could not possibly be that easy!” The report in VISION™ was formatted in such a way that the data could be highlighted, then copied and pasted directly into a spreadsheet, where it was automatically formatted to appear identical to the VISION™ report. All that remained to be done to it was to save and send it.

While ease-of-use is a great quality for VISION™’s ad-hoc reporting features, users were most impressed by how useful the actual reports were. For example, in one study, there were multiple time points at which a particular scale was assessed. It was possible to monitor the trend in changes by developing a report that showed the results of these scales across time. In another study, the monitor developed a report showing weight change across time. Yet another showed the progress of enrolled subjects through the study visits all the way to termination and indicated whether the cases were evaluable or not. Another monitor found it useful to create a report that not only indicated particular results, but who entered them and when they were entered.

Using the search criteria also allowed the project manager to view stratified reports by gender and age range. This allowed them to report specific critical information to the sponsor, and because the sponsor also had access to VISION™, the search criteria and report could also be shared, allowing for better communication about the study’s progress.

In one study, the ad-hoc reports were used to quickly monitor the change produced by different treatment groups. This information was used to identify whether additional mid-study analysis was required on the efficacy of a particular treatment. This lead to the eventual removal of a treatment arm from the study; future enrollees were stratified to the remaining treatment groups. The result was improved safety of future enrollees and reduced costs.

Overall, the study personnel who used the reporting function found it to be a tremendous asset to their role in the study. The project managers, sponsors and monitors found it extremely helpful to know real-time details and study progress.

About Prelude Dynamics & VISION™

Prelude Dynamics is a global provider of customized web-based software systems for data collection, analysis and management of clinical trials, studies and registries. We streamline eClinical operations through our unique and innovative VISION™ software system, which allows us to rapidly configure data collection solutions for pharmaceutical, CRO, medical device, animal health, and university organizations.