Crohn’s disease patient recruitment for clinical trials
Need help accelerating your study?
Crohn’s disease patient recruitment for clinical trials
Need help accelerating your study?
Crohn’s disease is a form of inflammatory bowel disease (IBD). Crohn’s disease is most prevalent in Western Europe and in the United States with around 2 million people affected in the first and around 3.2 million people in the latter.
Crohn’s disease is rapidly becoming more common both in developed countries but also is growing worldwide, but recruitment problems have increased in recent years, delaying many studies of Crohn’s disease. We have successfully managed patient recruitment for more than 15 international clinical trials for Crohn’s disease in both Europe and the United States. By learning about the needs of Crohn’s disease patients through large-scale patient surveys and using innovative, data-driven, digital recruitment campaigns, we were able to achieve more referrals and under budget.
Overcoming challenges in Crohn’s Disease patient recruitment
In recent years, clinical trials for Crohn’s disease have progressed at a rapid pace. This is underscored by the fact that since 2018, there have been more than 10 trials for biologics alone that have either started or are in phase 2 or 3. Despite this success, there is a growing awareness among organizers that future clinical trials in Crohn’s disease might have serious complications and delays due to patient recruitment challenges.
Our Study Feasibility team analyzes the recruitment challenges for our key indications constantly in order to be able to rapidly adapt both ongoing and future recruitment campaigns. We do this on the basis of literature reviews and patient surveys.
Understanding the patient population
Our Patient’s Insights and creatives teams conducts largescale surveys and analyses of past campaigns to get a throughout understanding of the local and global cardiovascular patient populations.
In a recent survey of Crohn’s disease patients, we found striking differences between the current local Crohn’s disease patient populations in Australia, Belgium, Canada, the Czech Republic, Denmark, Germany, Hungary, Poland, the Netherlands, the United Kingdom, and the United States and the patient population assumed in many older literature studies.
For example, an important finding from our survey was that one-third of the patients surveyed in these countries did not know what type of medication they were taking.
This is critically important because it makes pre-screening much more difficult, but it also limits the ability of patients to seek alternative treatments on their own
https://academic.oup.com/crohnscolitis360/article/2/2/otaa021/5815298
Crohn’s disease and minority patient recruitment
While the general consensus among scientists has long been that Crohn’s disease has by far the highest prevalence rates in white populations, Crohn’s disease occurs in all ethnic groups worldwide. In the past year, experts in the field have increasingly pointed out that there is a lack of research and understanding of how Crohn’s disease affects minority populations.
For example in 2021 researchers from the Harvard University noted that it might be likely that Crohn Disease as other irritable bowel diseases (IBD) is a “underrecognized health problem in minority populations”. They highlight that for example black people are more likely to undergo surgery for Crohn disease and also are more likely to experience complications after surgery.
For this reason, it is important for trial organizers to be aware of the specific issues faced by minorities with Crohn’s disease, and this can only be achieved through better inclusion in clinical trials.
Recent key findings on Crohn Disease in minority populations include:
- Patients of African descent are more likely to have Crohn’s disease affecting the perianal area
- Studies in the United States show that patients of African American, Hispanic, and Asian descent are 32%, 30%, and 69% less likely to have resection surgery to treat Crohn’s disease than white patients.
- African American and Hispanic patients had lower levels of knowledge about Crohn’s disease but reported that Crohn’s disease significantly affected their lives.
- Black children with Crohn’s Disease were more likely than white children to be hospitalized after receiving treatment for Crohn’s Disease. In addition, hospitalizations were longer and occurred more frequently in black children. This shows the need for including more black patients in Crohn’s Disease trials or even opt for control groups with exclusively black patients to analyze underlying disease patterns.
These are the top 4 challenges in recruitment for Crohn’s Disease randomized controlled trials (RCTs):
Increased number of IBD drugs in development
Other recruitment companies base predictions on estimates or opinions. Our Feasibility Screening tools empower you to collect live data directly from study investigators.
With more reliable data at your disposal, you can refine the study design as needed and develop more accurate timelines.
Increased number of available approved treatments
With the recent availability of multiple approved medications with different therapeutic mechanisms for Crohn’s disease, patients are less likely to seek new treatment options despite dissatisfaction or side effects. This is also a topic of health literacy.
Increasingly difficult exclusion criteria
Meta-reviews show that in Crohn’s disease trials, the number of patients that have a screener failure is rapidly increasing to over 40%, largely due to the growing list of excluded concomitant medications. For this reason experts have suggested to limit the usage of this exclusion criteria as it also does not reflect the real world patient population.
Site selection difficulties
Sites must be selected based on knowledge of the size and needs of the local patient population. However, sponsors often have difficulty correctly assessing the local situation and for example have no knowledge about the best channels to reach local patient populations.
Lack of understanding participation motives
Experts highlighted that factors influencing participation include academic practice setting, more severe disease, and worse quality of life. As Cole Johnson et al note in 2020, “expanding the pool of potential participants” is crucial to “”reduce the recruitment burden and produce results more generalizable to the real-world population of patients with IBD”.
Our digital targeting techniques
We have four ways of targeting patients and caregivers when performing migraine patient recruitment or migraine patient surveys, and continuously review performance to optimize engagement and trial registrations.
Location targeting
We reach Crohn’s Disease patients living in areas within a predesignated radius around sites. Depending on the trial protocol, we create a detailed patient profile and matching targeting method.
Interest-based targeting
Patients searching or engaging (e.g., likes, shares, comments, etc.) with Crohn’s Disease symptoms or treatments are shown study advertisements. At Clariness, we apply great importance to the representativeness of our advertising. We include images of people from different backgrounds.
Demographic targeting
Crohn Disease trials face a decreasing participation and under-representation of younger patients and those with milder disease. Based on our patient profile, innovative digital outreach, partnerships and informative content we are able to recruit these groups.
We target group-specific barriers, from lack of trust in clinical science among minorities, to travel distance and understanding of difficulties in participating and health literacy.
Behavioral targeting
We select from over 40+ possible digital channels the most cost-effective option and reach out to our large ClinLife database with a total of 1.3 million users worldwide, based on their location and the trial protocol inclusion and exclusion criteria. As a result from multiple largescale surveys for Crohn’s Disease we have a good understanding of their needs.
Are you designing a Crohn’s Disease clinical trial, or have one underway?
We can help you find the right patients, at the right time. To find out more about our Crohn’s Disease patient recruitment, contact us.