Need help accelerating your study?
Need help accelerating your study?
We boost patient recruitment for your ulcerative colitis trial by understanding the patient population and data driven outreach methods
Ulcerative colitis is a form of inflammatory bowel disease (IBD) that is most prevalent in the economic west. More than 5 million people worldwide suffer of ulcerative colitis and the numbers are increasing. While cases in western countries rise steadily, newly industrialized countries currently experience a rapid increase in the incidence of the disease.
With 19 years’ experience in patient recruitment and managing the recruitment for multiple ulcerative colitis studies, Clariness is the ideal partner to find the right patients for clinical trials. We showed that our patient-centric approach combined with data-driven digital outreach methods proves to refer more patients to sites while staying under budget.
Overcoming challenges in clinical trial recruitment for ulcerative colitis
Ulcerative colitis is a challenging indication for patient recruitment and retention. In the past years, study protocols have become increasingly more difficult due to regulatory demands. This development results in high study costs and a longer completion time of the clinical trial. Restrictive study protocols that exclude a substantial number of people with ulcerative colitis, add to the patient’s burden which among others lead to an overall decrease in the patient recruitment rate for ulcerative colitis.
With successfully managing patient recruitment for several studies, we deepened our expertise for this indication and showed that our approach of patient centricity and data-driven digital outreach proves to refer more patients to the sites with a lower budget. Our Study Feasibility team consistently evaluates recruitment challenges for our key indications, aiming to swiftly adjust ongoing and future recruitment campaigns. This analysis relies on literature reviews and patient surveys. Additionally, our Creatives Team creates study material that is tailored to the needs of each unique clinical trial and drives enrollment through patient-friendly informative and educational materials.
Understanding the patient population
Initially, ulcerative colitis was assumed to be a disease that mainly affects people of Western European descent. Today we know that IBDs such as ulcerative colitis are a worldwide issue. Factors that can influence the ulcerative colitis prevalence in a country are industrialization, urbanization, and westernization. On the one hand, those developments lead to an increase in technology, which allows better diagnoses and enables a better uncovering of ulcerative colitis cases. On the other hand, people in westernized urban environments are exposed to diets that contain more fat and sugar, a change of lifestyle that may contain smoking, less breastfeeding, and higher use of antibiotics – all factors that influence the ulcerative colitis prevalence of a country. Due to the ongoing tendency of urbanization and the adaptation of a “Western” lifestyle outside of North America and Europe, it can be assumed that clinical trials in other regions will play an increasingly crucial role in ulcerative colitis research. A study, published in Nature Magazine in 2020 concluded that Asia and South Africa currently experience an acceleration in the incidence of IBDs.
We are aware of such developments and have experience in recruiting in different regions of the world. In one study that covered the regions Eastern Europe, Western Europe, and the Asia Pacific Region we managed by using,
- A multi-channel outreach approach, including search engine marketing
display advertising and social media advertising
- A two-level pre-qualification process including online and phone-based pre-screening for potential subjects
- An active site support to contact, process, and enroll referred patients
An international team of scholars did a systematic review in 2023 to understand the magnitude of the underrepresentation of certain population groups in clinical IBS. The evaluation of those 627 randomized controlled trials (RCT), including more than 100.000 patients reflects a lack of diversity in clinical IBD trials concerning ethically and racially diverse groups, younger populations (<18), and older populations (>65). Furthermore, a lack of representation of people who identify outside of the gender binary and people from South America and Africa was found.
The risk and likelihood of developing a disease, the way a person experiences the disease, how a person responds to the treatment, and ultimately the long-term health outcome are influenced by diverse factors. Some of them are biological sex, age, unhealthy behaviors, age, environmental conditions. Research shows the importance of considering such factors to develop the most effective treatments for all parts of society. Thus, clinical trial organizations must understand the importance of diversity in clinical trials. If you want to learn more about how to reach diversity in clinical trials, you can download our Whitepaper.
Enrolling patients aligned with your protocol
Our in-house medical team reviews your protocol and aligns with our patient recruitment team’s objectives and tactics to ensure that patients referred to your research center fit the requirements of your study.
Our medical team then creates the dedicated study and indication pages and pre-screeners, as well as standardizes the script of the telephone screener. The telephone screener confirms that patients who successfully completed the online pre-screener do fulfill the study’s eligibility requirements. This reduces the workload and frustration felt by the study center and the patient. We also provide patient-friendly content that explains clinical trials, regulations, safety measures, and specific processes during the clinical trial. This helps ensure that all patients, across different countries and age ranges, are better informed and less likely to drop out during the trial.
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.
We reach Ulcerative colitis 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.
Patients searching or engaging (e.g., likes, shares, comments, etc.) with Ulcerative colitis 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.
Based on our patient profile, innovative digital outreach, partnerships and informative content we are able to recruit various 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.
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.
Are you designing an ulcerative colitis clinical trial, or have one underway?
We can help you find the right patients, at the right time. To find out more about our ulcerative colitis patient recruitment, contact us.