Despite the need for new treatments, IBD trials have low and declining enrollment rates. In Crohn’s disease trials, over the last 10 years, the patient enrollment rate has declined by 50%, and for ulcerative colitis trials, over the last five years, the patient enrollment rate has declined by 13%.1
To counter declining enrollment rates, companies conducting IBD trials – like those across most indications – typically add research sites, thereby increasing costs, change orders and timelines. For example, over the last 10 years, the average number of research sites in Crohn’s disease studies has increased by 193%.1
Our approach to enrolling IBD patients is targeted and proven. We leverage a database of more than 18 million potential gastrointestinal patients – including 1.8 million people self-reporting Crohn’s disease or ulcerative colitis – and augment our recruitment efforts with referrals from our network of gastrointestinal specialist partners throughout the world. Then, to solve one of the biggest challenges of recruiting patients for IBD trials – finding and enrolling patients in flare – we regularly re-engage with pre-qualified patients using our MyColo mobile app and telephone outreach. In this way, we are able to identify patients in flare and quickly schedule them at their local clinical trial site in time to enroll in the study.
In addition, if you choose our Integrated Network & Patient Recruitment solution, which recruits volunteers and patients directly to AES-owned research sites, we can also provide more than 40 dedicated research sites with teams that have previously run IBD clinical trials.
- GlobalData, AES analysis. March 2021.