Impacting Enrollment Performance

In this section, we share examples of work that we’ve done on behalf of our clients.

 

Targeted Strategy Pinpoints Prostate Cancer Patients


Challenge

A European company retained FHCTD to recruit Americans 60 years of age and older with early stage prostate cancer. One of the Phase II study’s challenges was that the two study arms were being conducted by different institutions, and the FDA confined recruitment areas FDA. The arm with the new treatment was considered revolutionary while the other arm used a fairly standard therapy that could result in negative sexual and urinary side effects.

Solution

Because of its newsworthiness, FHCTD deployed media relations in cities where the study sites were using the revolutionary therapy. For sites in the other arm, FHCTD used grassroots marketing to deliver a comprehensive message in personal settings. A search engine marketing (SEM) campaign directed patients to a study Web site, and an online prescreener and call center directed inquiries to appropriate study sites.

Results

This is still under way. Early results show that SEM is outperforming other strategies, is easier to implement, and provides more frequent and ongoing results. In the first three-months, more than 28 percent of all referrals resulted from SEM. SEM drove 379 visitors to the online prescreener. More than 39 percent completed prescreening and more than 30 percent were referred to study sites.

 

Media Helps Enroll Largest Global MS Study


Challenge

The CORAL Study was the first global study for an oral multiple sclerosis (MS) therapy and the largest clinical research trial on MS at the time. The 56-week study aimed to determine if an oral formulation of COPAXONE was safe and effective in treating relapsing-remitting MS, the most common form of the disease. The study took place in 18 countries, and investigators needed to enroll 1,300 patients within six months.

Solution

FHCTD produced a variety of media materials, including b-roll and a mat release for patient organization use. The team also built a toll-free call center to fulfill calls to action. A 25-city North American media blitz; issued releases via PRNewswire, MedNews, and the Internet; and partnered with patient organizations globally to reach key audiences.

Results

The enrollment goal of 1,300 patients was met in three months. News of the CORAL Study reached more than 88 million people, generated over 110 million impressions, and drove 10,000 calls to the toll-free line. ABC, NBC, and FOX distributed the b-roll nationally. Television coverage was secured in 84 markets and in 12 top-40 radio markets. Print media coverage generated more than 17 million impressions, including stories in Better Homes & Gardens, the Houston Chronicle, and BioWorld Today. Several key Web sites announced the news, including Yahoo!, Reuters, and Health News Daily.

 

News Coverage Opens Eyes to Leading Cause of Blindness


Challenge

A biotechnology company asked FHCTD to help recruit about 200 patients with a specific form of age-related macular degeneration while a competitive product received FDA approved and launched. FHCTD’s research showed that only 20 percent of patient with AMD would qualify for the study. Further, this was the sponsor’s second AMD trial in a year’s time.

Solution

A key strategy was to notify referring physician of the study opportunity and ask them to encourage patient candidates to follow up with a call-to-action. FHCTD also conducted an 11-city media campaign, taking care not to duplicate markets in which the previous study was promoted.

Results

The study enrolled on time, with sites that participated in the media campaign realizing a 25 percent increase in enrollment. Overall, the targeted media outreach generated 4.5 million impressions. The call center fielded nearly 700 calls, with 79 percent of patients confirming they learned about the study through the media. Of the 546 patients who called, 223 were referred to study sites for final screening.