Patient Recruitment Case Study: Primary Biliary Cholangitis - Stark / Raving Health
What are you looking for?

Patient Recruitment Case Study: Primary Biliary Cholangitis

A phase 2b/3 clinical trial evaluating a potential additional treatment for primary biliary cholangitis (PBC) and liver stiffness

THE CLINICAL TRIAL
Primary biliary cholangitis (PBC) is a chronic liver disease caused by the destruction of the bile ducts in the liver. Bile is produced in the liver and travels through the bile ducts to the small intestine. When these ducts are damaged, bile builds in the liver and leads to inflammation, fibrosis, and cirrhosis. There is no cure for PBC. There are treatments available to slow the progression of liver damage, but they are not effective in all patients. This creates an unmet need for PBC patients. The TRANSFORM Trial is evaluating a secondary treatment for PBC and liver stiffness that, unlike current medications, is meant to specifically target the causes of inflammation and fibrosis.

 

THE PROJECT
With such a small study population who were often dealing with severe symptoms, study teams were facing some unique challenges with recruitment. PBC is a rare disease, affecting only up to 1 in 3,000 people. Of that small population, the clinical trial was only recruiting people with moderate-to-severe disease who had already undergone first or second line treatment. Our approach was focused on understanding the patient profile of PBC to develop a compassionate, educational study toolkit for both potential participants and site staff.

Patient recruitment clinical study branding services
Patient recruitment branding services for Primary Biliary Cholangitis clinical study
Patient recruitment branding services for Primary Biliary Cholangitis clinical study

Messaging that empathized with PBC patients to increase recruitment and retention.

People with PBC often experience debilitating symptoms, like fatigue, weakness, and pain. As a result, the Sponsor was actively trying to minimize the study burden on participants. With this in mind, the we created messaging centered on making participants feel understood and cared for, while providing education around this rare disease. Extending this theme to the design, we developed study branding that would convey calmness and clarity to contrast the struggle potential participants would likely be going through.

Patient recruitment clinical study branding services
Patient recruitment clinical study branding services

Using key study information to differentiate the clinical trial opportunity.

Emphasizing the study benefits was an important strategy in the site-facing materials. Not only was the study designed with the limitations of the study population in mind, but the investigational medication was a first-in-class drug—the intended mechanism of action was designed to target the cause of the disease, which was different than anything currently available to treat PBS.

Patient recruitment clinical study branding services
Patient recruitment clinical study paid digital advertising

Put our solutions to work for your next clinical trial.

Contact Us
Back Top