Background: Adaptive clinical trials bring in flexibility, efficiency and improves the satisfaction levels of clinical trial subjects. This ulcerative colitis study by 3H has been executed to enhance patient centricity. Ulcerative colitis, a rather less common medical condition has had limited clinical trials performed in the past. However, novel therapy is opening doors for improved treatment. This clinical trial by 3H aimed to recruit adult subjects with active ulcerative colitis. Individuals between 30 to 40 years showed a keen interest in participating. The ratio of males to females recruited were 50:50. The recruitment sites were selected to represent local demographics with an aim to include all regions.

Challenges: The conduct of clinical trials in ulcerative colitis is challenging due to its increased complexity and difficulty in patient recruitment. The demands in this therapeutic area result in complex protocol execution and unintended negative consequences which may incur higher costs and longer duration compared to other disease conditions. Thus, innovation in the design and conduct of clinical trials is needed for faster recruitment. The subjects in these clinical trials are mostly young and have family commitments. Many need to continue with breast feeding and pregnancy. Some of the patients did not want to be referred to other physicians as they were worried to cut off ties with their doctors. In addition, not all patients were in the active phase. Presence of diarrhoea’s and bleeding could not be confirmed in some individuals due to their current use of medications.

Solution: 3H has been able to deliver a range of innovative and flexible recruitment strategies to boost the awareness about ulcerative colitis as well as ease recruitment challenges. Some of the key strategies deployed were:

·     Empowering ulcerative colitis subjects: The knowledge of patients about the indication was strengthened. A community page on RareS website was developed. This helped in providing a platform to understand common questions about the indication. Listening to patients closely has helped in better articulation of 3H recruitment strategies and reaching out to potential subjects.

·     Easy Access to Physicians: Patients usually want to hold good relationships with their doctors. To make the subjects feel more comfortable, a tool was developed where the subjects could communicate with their doctors at ease.

·     Recruitment Tools for Site Staff: Centrally approved recruitment materials were provided to sites. To help the principal investigator and clinical research coordinator to easily access inclusion and exclusion criteria, mini-sized pocket protocols were provided. This way potential subject enrollment was strengthened.

·     Multi-channel advertising: Online advertising was done in Seikatsu Kojo-WEB and two other prominent online patient databases. Multiple advertisements were also run on ulcerative colitis online advocacy groups. Advertising displayed easy to reach, toll free numbers which could be used by potential subjects or caregivers to learn more about the trial. Search engine based advertising optimised for key words such as ulcerative colitis, crohn’s disease, IBD and IBD related symptoms was done, targeting potential candidates to the study page on ulcerative colitis. Further, study specific advertisements were also run in pharmacies nationwide to reach the potential patients.

·     Referral system:  A strong referral system was set up to help general practitioners to send their patients to screening centres.

3H was able to successfully implement and execute the trial to reach the recruitment and retention target of sponsor.

·     The innovative approach helped to maintain compliance under a framework approved by the sponsor

·     The advocacy groups and the community was very receptive to this clinical trial. Referrals came in easily. More than 2100 initial phone calls were received.

·     The funnel chart for advertisement showed 15000000 impressions from search engine based advertising and 840 queries. 6 patients were enrolled this way

·     Pharmacy display advertising across Japan helped to recruit subjects from both urban and rural areas to represent and add diversity to the study.

3H’s specialists were able to identify the challenges prior to initiating the clinical trial. A key challenge was finding patients for this clinical trial being a less common indication. Thus, innovative recruitment strategies were set up by 3H to boost recruitment. Setting up an online study page, search engine optimised advertising and multi-channel advertising both online and physically across nationwide pharmacies helped in identifying a potential subject base within a short span of time. These recruitment strategies provided the boost for successful recruitment.

To learn more about how we may help you and your study, kindly reach us at imran@3h-ms.co.jp