Cough: Study solutions for a global trial

Background

A customer was conducting a suite of phase II/III Clinical trials to investigate the efficacy and safety of an investigational medicinal product in patients with chronic cough.  These were global studies with >300 sites, >3000 VitaloJAKs and 30,000 sensor kits and data cards. Several of the primary and secondary endpoints for the study were objective measures of cough, evaluated using the VitaloJAK device which records sounds from the lungs and trachea through a chest contact sensor, as well as ambient sounds through a lapel microphone.  Due to the scale and complexity of the studies it was important that key performance indicators (KPIs) were routinely reviewed, and additional procedures were put in place to ensure the smooth running of the studies.

The Solution & Benefits

The scope of the studies were reviewed and the following provisions were put in place:

• Designated Vitalograph Web Portal configured to the specification of the study to give secure, restricted access to a centralized system for the collection and management of study data. This facilitated study management and oversight, patient and device management, centralized review and analysis capabilities.
• Training was provided at 4 regional centralized investigator meetings and these were supported by web-based training for sites that were not able to attend the investigator training or where new site technicians had been recruited onto the trial. Retraining was provided when quality issues were found at sites.
• Governance meetings were routinely held to assess the overall running of the study to manage and control performance of the study against KPIs, and to manage and control risk within the study. These meetings drove continuous improvements and ensured the studies were delivered on time.
• 14 generic reports and 8 customised reports were created. This helped with sponsor analysis of the data and general tracking of the study status.
• 4 reports were automated so that any cough events were automatically emailed to the sites and study coordinators to ensure they could be addressed immediately, thereby improving the quality of the study as it progressed.
• Specific reports were blinded to ensure the anonymity of the data to specific users.
• Synergies across the studies in the program were implemented across data management, software development, provision of equipment and logistics which led to a 30% saving in study costs and in reduced timelines for setting up the studies.
• Brexit contingencies were put in place to ensure that there was sufficient equipment available and that shipping of study supplies could be transferred to different locations with no impact on timelines or budget.

Summary

The VitaloJAK is the only validated tool for objective measurement of cough in clinical trials. The sponsor utilised the VitaloJAK cough monitoring system to capture several of their studies primary and secondary outcome measures. Due to the scale and complexity of the studies and to ensure clear communication and transparency of the study at all times, additional reporting services and governance meetings were required compared to a standard study. The studies finished ahead of schedule with reliable, quality data.