Addressing Challenges with Ulcerative Colitis Clinical Study Recruitment

We understand the significant challenges sponsors face with patient recruitment in their ulcerative colitis (UC) clinical studies. While the prevalence of UC is relatively high (~0.2% in North America, Oceania and much of Europe – and rising in urbanized/industrialized countries in Africa, Asia and Latin America¹), recruitment rates into clinical studies are woefully low. Achieving a linear average recruitment rate of just 0.1 patients/site/month* is considered the standard (*calculated by dividing total patient accrual by number of sites by overall recruitment window [months]).

The patient recruitment challenge in UC studies is primarily driven by the extreme competitive trial landscape. As of July 2021, there were over 115 industry-sponsored, Phase I-III adult UC studies either in the planning stages or open to recruitment. The environment is similar for studies in Crohn’s disease. The impact of this level of research activity on observed recruitment rates is visualized in Figure 1, which shows the trend in number of UC studies initiated each year and associated average linear recruitment rates over the past 20 years.

Figure 1: Trend in UC Patient Recruitment Versus Number of Studies

Data Source: Citeline Trialtrove

For patients living with this chronic condition, this observed level of clinical trial activity is promising to address unmet medical needs. However, drug development is impacted by the associated lengthy trial timelines. Studies are taking longer to recruit and/or are requiring a larger number of sites. We have observed that it is not uncommon to see studies with as many active sites as the target patient accrual. Table 1 summarizes study recruitment metrics from industry-sponsored, Phase II-III adult UC studies that have completed since 2015. When viewing the median values, each site requires over two years to randomize less than three patients. 

Table 1: Phase II-III Industry-Sponsored UC Study Recruitment Metrics (Since 2015)

Another primary factor driving low patient recruitment rate is the relatively small percentage of patients that participate in clinical studies, estimated to be about 10%².

Examining solutions to increase patient recruitment in UC studies

To address the competitive clinical trial landscape, we must increase the number of patients participating in clinical research. Based on past experiences, there are a number of solutions available, such as:

• Collaborating with Patient Advocacy Groups (PAGs): PAGs provide education on the disease, explain the available treatment options, advocate for new and better treatments and build supportive patient communities. Involving these groups in protocol design and review of patient-facing materials helps sponsors capture real patient insights and also allows these patient groups to feel invested in the study and more willing to share with their community. It is also possible to partner with PAGs for study education and awareness through social media, newsletters or publications.
• Identifying New Investigators: Based upon the competitive trial environment, sponsors cannot continue to solely rely upon the investigators they have previously used. The majority of these sites will be conducting multiple UC studies simultaneously. Sponsors must seek new investigators and invest in the time to train these sites regarding Good Clinical Practice (GCP), local/national regulations and the specifics of UC clinical research. A proactive approach allows for the additional time required to set up new investigators, without negatively impacting the critical path for study start-up.
• Incorporating Decentralized Clinical Trial (DCT) Solutions: Through voice of the patient (VoP) surveys from Labcorp Drug Development data, we know that, in general, UC patients are unwilling to travel greater than 25 miles to participate in a clinical trial. Applying DCT solutions to clinical trials not only increases patient centricity in general, but very specifically expands the available patient population by “bringing the trial to the patient.” Patients will still need to visit the clinic for any colonoscopies or biopsies, but all other visits can be conducted virtually – with patient/site applications, telemedicine and/or ePRO. Home nursing can provide brief physical exams, vital signs and biological sample collection. Additionally, patient consent can be obtained via electronic consent (eConsent) and supported by telemedicine. This patient-centric approach not only has the potential to increase patient recruitment but also to increase patient retention.

We believe our industry has an obligation to find ways of giving patients greater access to clinical trials – and ultimately getting new drugs to the market as quickly as possible. We must recognize the unique needs of UC studies and help push science forward with a new level of proactive and patient-centric solutions.