Case Study

NASH

Recruiting for a Silent Disease

The Challenge

A pharmaceutical company was engaged in a Phase 3 trial with a promising compound to treat non-alcoholic steatohepatitis (NASH). NASH, a serious, inflammatory form of fatty liver disease, is often found in Type 2 diabetics and patients suffering from obesity. Finding patients with NASH is challenging as they are often undiagnosed and unaware of disease implications, including liver failure and liver cancer. After unsuccessfully screening many patients, with a rapidly approaching deadline, the client hired nRollmed for a two-month period to boost recruitment. A total of 100 patients were needed for screening. Currently, no drug has been approved for the treatment of NASH. The first line of treatment is a change in lifestyle. Therefore, any patient who had not yet tried lifestyle changes with professional guidance, was not referred to the sites. Biopsy is the only definitive method of diagnosis. This was a sensitive issue when engaging with patients – it was important to be straightforward, but to also not scare away potential participants.

Customized and Collaborative Approach

To overcome the challenge of finding people with a disease that goes so frequently undetected, nRollmed employed a multi-layered strategy, targeting only those with common, relevant risk factors. A scoring system was developed to assess a candidate’s likelihood of suffering from NASH. nRollmed’s team put together a strategy for discussing the need to have a biopsy with patients. A focus was placed on education about the disease and what the study would entail. The patients’ approval for potentially undergoing a biopsy was verified before they were referred to the sites, ensuring that the sites’ valuable time was not wasted. As this process was refined, information was collected on the specific steps taken by successful sites, which nRollmed then shared with other sites so that they could replicate the process.

The nRollmed Method

Book a discovery call

Results

In just over 2 months at 5 clinical sites in the U.S., nRollmed referred 122 patients, out of which 33 signed consent, 21 underwent biopsies, and 4 were randomized.

As a so-called ‘silent disease’, NASH poses a significant challenge to trial recruitment. The NASH clinical trial industry standard is 0.15 randomizations/month/site. nRollmed’s ratio was 0.4, more than double the NASH clinical trial industry’s statistic. In just over 2 months at 5 sites in the US, nRollmed referred 122 patients, out of which 33 signed consent, 21 underwent biopsies, and 4 were randomized.

122

referred patients

signed consent

underwent biopsies, resulting in 4 randomized patients

nRollmed performed at more than 2X the NASH industry standard.

Download PDF

To discuss your study needs and how we can help recruit patients faster