Ensuring consistent source data monitoring for a global cardiology study

This interventional cardiology study evaluated the clinical efficacy of an atrial shunt. Evaluation of the device assessed improvement in quality of life and reduction of heart failure-related symptoms and events in heart failure patients who were symptomatic despite receiving standard-of-care therapy. This global study was double-blinded, with 260 randomised patients participating over approximately 4.5 years. The study spanned 66 sites in the USA, Australia, Canada and four European locations. Control patients could opt into the study treatment after two years with monitoring of study participants for five years after treatment. 

The sponsor needed to update their risk-based monitoring strategy to source data verify (SDV) patient primary endpoints as enrolment progressed. The initial set-up was modelled on a prior study conducted with a different CRO. In that set-up approximately 33% of patients were source data verified after all patient visits were completed (2-5 years after enrolment). ICON and the sponsor shared concerns that this led to a lack of oversight during enrolment. 

While updating the monitoring strategy ICON identified several challenges with monitoring visit trip reports. These challenges were compounded due to the multiple geographic regions. The following goals were established:

• Maintain consistency with writing, formatting and sponsor expectations for content inclusion
• Track source data review across all regions consistently
• Expand CRA-PI discussion documentation during patient visits
• Align SDV of concomitant medications and adverse events (within the time constraints of standard monitoring visits)
• Uniform documentation of device accountability for all regions

ICON proposed sharing responsibilities for the trip report reviews with the sponsor as some aspects called for adjudication and other sponsor inputs. This ensured that the monitoring expectations would be aligned throughout the project’s term. The monitoring plan was updated with clearly defined roles and responsibilities for review and finalisation of trip reports. All ICON and sponsor clinical oversight team members were retrained to follow the new monitoring plan and strategy. 

Effective collaboration between ICON and the sponsor ensured:

• Device accountability section reviews included sponsor input
• Close monitoring of AE/SAEs reviews for adjudication by the sponsor
• PI discussions clarifying actions during monitoring visits
• Monitoring and alignment of visit follow-up actions 

ICON developed a trip report template for use across all regions to ensure consistency at all 66 sites.

Using the updated trip report template improved the sponsor’s understanding of the content. Aligning the template with sponsor expectations resulted in fewer queries and action items issued to sites. This reduced the need for follow-up questions and corrections. Efficiencies improved as the clinical trial progressed with concise documentation, fewer report review iterations, fewer queries and more timely report finalisation.