T-10: Real-World Data Meets Real World Evidence in Patient Recruitment and Engagement
Director of Market Development
BBK Worldwide United States
Provide an understanding of the promise of health databases with regard to improving the “enroll-abilty” of clinical trials, and how data can be leveraged in practice – and when the practice should uphold or deviate from the theory – in order to best leverage health data for projects.
Using data from multiple global trials, we will explore real world evidence (RWE) pointing to the decisive role of support and engagement programs in recruiting and retaining study participants.
In large measure, the terms “Real World Data” (RWD) and “Real World Evidence” (RWE) were crafted to differentiate between what happens in the controlled environment of a clinical trial, and what happens once a treatment is set free into the larger marketplace. There are many applications of these data in the early stages of compound strategy development, protocol design, feasibility and site selection. The information gathered from the “Real World Evidence” often challenges the results of previous clinical trials, but also shines new light on the impact of treatments on the lives of patients and the practices of physicians. We applied these constructs to patient engagement, enrollment and retention in clinical trials – where “Real World Data” represents the information about the people who are living with a condition, and real world evidence is the measurement of how well we use these data.
As part of our research we took a close-up look at key performance metrics from two recruitment and retention programs – one for neo-nates and one for people suffering from opioid induced constipation (OIC). For the neo-nates study, we evaluated the impact a travel program had on withdrawal rates – results showed a withdrawal percentage of 5.8% for sites using the travel program and a withdrawal percentage of 13.8% for sites not using the program. For the OIC study, we observed a withdrawal percentage nearly 2.5x greater for sites not using a reimbursement program.
In these programs, we have the evidence to demonstrate the power of patient engagement on both recruitment and retention. Findings reinforced the obligation to be using this evidence to help bridge and improve understanding between what planned performance is and what actual performance is.
Today we have access to multiple health databases containing myriad data points that can be integrated, correlated and mined. The expectation is that these data will help researchers to better define target patient populations, improve protocol design, and enhance site selection. But will these efforts advance patient recruitment and retention? Using data from multiple global trials, we explore RWE pointing to the decisive role of support and engagement programs in recruiting and retaining study participants.