CASE STUDY: Dermatology Study Met Enrollment Goals 5 Months Ahead of Schedule

Challenge #1:

Selecting the Right Sites for Faster Clinical Trial Enrollment

Proper site selection is always critical to study success, and is very often challenging. According to information from Pharma Intelligence Informa, two-thirds of all clinical trial sites are unable to meet enrollment goals, with half of all sites recruiting one or zero patients.

In this study, the challenge of selecting the right sites was amplified, as there was a limited number of viable investigative sites due to equipment scarcity and timeline constraints. In fact, only two sites in the US were eligible for the study. Of these two eligible sites, one had very limited clinical research experience.

It was determined that the best course of action would be to utilize both available sites, ensuring excellent support and realistic goals were used for the site that was newer to clinical research.

Challenge #2:

Challenges due to the COVID-19 Pandemic

As both sites began enrollment patients, a second major, unexpected challenge arose: COVID-19. The study was paused as closures occurred due to the pandemic.

Across the industry, COVID-19 caused an unprecedented challenge for investigators, sponsors, and CROs. According to a study by Medidata technology and solutions, the ability to conduct clinical trials during the pandemic had affected 69% of respondents. Over half of all respondents mentioned concerns with subject enrollment and recruitment. New studies were especially hit hard, with 78% of respondents reporting the pandemic had affected the initiation of new trials.

Results:

Faster Clinical Trial Enrollment

When the study resumed, sites were flooded with prospective patients. Despite the ongoing pandemic, enrollment completed 5 months early.