ICON operationalized a hybrid decentralized clinical trial for participants experiencing bothersome Vasomotor Symptoms (VMS). Participants engaged with a digital platform to complete eConsent, ePROs, daily eDiaries and telehealth visits. In addition, participants wore an actigraphy watch to report hot flashes and passively collect sleep data. The primary and secondary endpoints were captured via the digital platform and actigraphy device.

Participants were required to complete ePRO compliance at each visit and daily sleep eDiaries while wearing the watch for at least 20 hours per day during two week periods with very high compliance. Pre-Baseline ePRO data was critical to be collected prior to first dose. Failure to comply may result in participant discontinuation due to missing primary and secondary endpoint data.

At the onset of the trial, the tracking system utilized to report non-compliance used free text fields within the system, which did not allow for trend analysis or distribution of content outside the designated team members due to risk of sharing patient identifiable information. 

In addition, the digital platform and actigraphy device were new to sites and ICON was not provided with vendor test environments of the various data capture tools and devices to enable sites to become familiar with the technology. 

To further compound these challenges, a near real-time data visualization strategy to review aggregate data to enable non-compliance monitoring and trend analysis was not originally within scope.

The ICON trial team developed the following process improvement strategies to gain better transparency into the endpoint data capture and promote overall trial compliance by: 

1. Implementing a non-compliance tracker as a standard offering to be run daily to report. events of non- compliance, daily compliance metrics and metrics broken down by participant, site and overall, as well as reporting metrics over time (trend analysis). 

2. Revamping the ticketing process, drastically reducing the use of free text by incorporating required drop down menus providing insight into the source of non- ompliance and the root cause, allowing for metrics and trends to be reviewed. 

3. Actively collaborating in daily scrums, both internally and externally, to ensure alignment and training for use of report was working correctly. These meetings were removed as we began to see a decrease in non- compliant events. 

4. Effectively communicating through dedicated compliance updates during regular sponsor calls. 

5. Retraining all sites on the end to end data capture ecosystem and providing a test actigraphy device to practice pairing, unpairing, uploading data and event marker presses. 

6. Developing training videos to target the site and participants environments, providing live demonstrations on how to progress through the trial using both the digital platform and actigraphy device.

We successfully demonstrated to the sponsor that compliance monitoring was being performed consistently and trends were easily identifiable, resulting in an increase in overall compliance of participant reported data.

In light of the insights into the non-compliance metrics and trends, the client is reviewing a possible protocol amendment to further support participant compliance.

The compliance metrics improved greatly to: