34 June 20 08 VIEW on Clinical Operations PATIENT RECRUITMENT re the needed patients available at the investigator sites? Answer ing this question incorrectly means that the clinical trial will fall short of its goal, and most trials run late due to patient enroll ment issues.The following case study illustrates how early scruti ny allowed the use of directtopatient advertising to solve an enrollment shortfall, before it occurred.The trial was a Phase II study of a drug for adults with pain due to osteoarthritis of the knee. Feasibility Work and Objective The initial feasibility work was misleading.The sites received little informa tion and overestimated their ability to recruit. Because the sites were accus tomed to the sponsor’s timeline slipping, they wanted to start first, and then decide whether to continue once the budget and protocol were final. The objective was to enroll 375 subjects from 52 sites.The day after the protocol was final, feedback to the sponsor made it clear that enrollment would be behind.The timeline drove the need to bring in a central recruitment service. Research on Patients Using insurance claims and other proprietary databases — Critical Pop ulation Research (CPR) — it was determined that 2 million patients nation ally had presented themselves for treatment in the past year. More than 2% of older adults had the condition, a very important number for planning. And a high enough number for mass media to be a costeffective option. The planning continued with a national disease prevalence map for osteoarthritis of the knee.The U.S. map shows red or hot areas, and statis tics prove that investigators in the hot areas have enrollment rates up to three times faster. In this case, the sponsor had already selected the sites. Many were in average or belowaverage locations, yellow or blue on the map.This finding supported a forecast that onethird of the needed patients would have to come from external recruiting. There were enough patients for advertising, so the media planning began. The targeting used a lifestyle segmentation system as a way to find the most patients based on income, where they live, and health behaviors. The research found that there were 66 possible groups of patients, called clusters, and the top cluster typically had 80 times more patients than the bottom cluster. Survey data revealed an important added element: patients who were the most willing to participate in a trial. The operating philosophy was that advertising to the top clusters would reach the most patients willing to participate in a trial.This approach would be more effective than traditional targeting based on age, resulting in faster trial completion. One site was located in Phoenix, which makes a good example for plan ning media. The leading cluster of patients there is called “American Clas sics.” Most of them are lower to middle income, own their own homes in suburban locations, and are older than 65. They use online services, think they should exercise more, think it is important to continue learning new things, and are willing to volunteer their time for a good cause. American Classics were perfect to contact for the trial. Survey data showed their media habits.They liked radio more than TV or newspapers.They liked the news/talk and adult contemporary radio formats. Other top clusters liked these radio formats too, and advertising was placed accordingly. Results Did it work? In Phoenix, the site enrolled seven patients with its recruit ment efforts.The advertising campaign was responsible for 14 patients. For all 52 sites, there were 9,596 inbound calls to the telemedicine con tact center from 36 weeks of outreach. Radio had the best return, followed by the Web. Newspapers had the worst results. The total number of ran domized patients who were recruited because of the advertising campaign was 130.The trial met its enrollment target three months early, 11 months instead of 14. Conclusions An analysis with the sponsor found that most sites wanted the help provided.They did not have the bandwidth to develop a campaign. Having centralized advertising, a central call center, a Web site, and other collateral support were all essential. Most important, the sponsorvendor partnership and sharing of research were the keys to proper planning and success. # Inclinix, Inc. INCLINIX, INC.,Wilmington, N.C ., is an international enrollment CRO with experience recruiting investigators and patients for more than 130 diseases and therapeutic areas. For more information, visit inclinix.com. DirecttoPatient Advertising Enhances Study Recruitment Bill Gwinn, Vice President, New Product Development A National Disease Prevalence Map for Osteoarthritis of the Knee Prevalence Highest Medium Lowest 0608 pvv layout FINAL 5/29/08 11:44 PM Page 34 Inclinix is an Enrollment CRO with specialized focus on clinical trial recruitment solutions. Our sole focus is to help you meet your enrollment goals, so you can successfully complete your trials. Our recommended sites are proven to enroll three times faster. Attain your goals with Inclinix. Visit us at DIA in Boston! Booth 235. Productive sites. Qualified patients. Faster enrollment. 18003880142 www.inclinix.com Watch Your Enrollment SOAR.

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