Recruitment: To Centralize or Decentralize? This is the Question. Liz Moench President and CEO Patient and Investigator Recruitment In many people’s minds, centralized recruitment often symbolizes big money and big studies. But in actuality, nothing could be further from the truth. In many people’s minds, centralized recruitment often symbolizes big money and big studies. But in actuality, nothing could be further from the truth. Dispelling the Myth about Centralized Recruitment Regardless of the scope and budget for patient recruitment, there is always a role for central management of a recruitment campaign that includes individual site support. Here’s why: 1Advertising buying clout. Centralized ad buying can create significant cost savings when advertising can be leveraged in markets with multiple sites. Additional savings are realized when advertising is directed to the most productive sites. 2Focused sites. Centrally managed recruitment allows study coordinators to do what they do best — see patients. 3Data-driven decisions. Research-driven media buys, using Arbitron or Nielsen ratings, provide accurate data to support sites equally, while reaching the study’s target patient population for each site. This is important since ratings and circulation data remove the risk of advertising decisions being made by inexperienced study staff who may buy what they, or their “family and friends” know. 4Uniformity and branding. An advertising campaign with a consistent visual look builds study identity for sites and patients. A Case Study: The Importance of Sticking with a Strategy A study involving more than 100 sites had been managing recruitment advertising at the site level. Since enrollment was poor a centralized advertising campaign was introduced to randomize the 700 patients needed within 10 months. Many factors contributed to this poor enrollment: • Coordinators were overloaded with recruitment and phone prescreening responsibilities. • No phone and Web prescreening support resulted in low advertising response. • Lack of media planning and buying resources meant that sites were not getting the best “bang for their buck.” • Lack of a uniform recruitment message resulted in misdirected advertising. And, without centrally managed real-time metrics to monitor recruitment activity, the clinical team lost control of the recruitment process. Within three months, a centralized effort demonstrated that recruitment would be achieved five months ahead of schedule. Recruitment advertising returned to a unified campaign strategy and randomization increased. The recruitment target was achieved. The optimal recruitment approach is a “hybrid” one, combining the cost efficiencies of central management with individualized site support. The Hybrid Approach Typically, sites will enroll an average of 35% of the required patients from their own databases. A hybrid strategy should only be implemented after sites have the opportunity to first recruit from their databases. Based on more than 10 years of research, we know that on average 30% of sites will not perform. Because of this, sponsors should not provide sites with recruitment funds until performing sites have been clearly identified. Otherwise, a third of the advertising budget will be wasted. The way to pin-point performing sites is to track recruitment results as sites prospect their databases to determine which ones do the best job — hence the performing sites will emerge. Steps to achieving an effective hybrid recruitment approach: 1Allow 4 to 6 weeks for sites to first recruit patients from their own databases, giving sponsors and CROs the data they need to determine performers vs. nonperformers. 2Determine the media plan by site that models the reach, response, and cost of each media and establishes a media budget. 3Involve sites in the planning process. Organize teleconferences to present sites with specific advertising options. 4Sites that want to advertise on their own, must first demonstrate that they have had previous experience with local advertising from studies in the same therapeutic area. Ask for a written request that outlines the type of advertising, its duration, text of the ad copy or script, and results achieved by media. 5Establish weekly tracking procedures that allow a sponsor to monitor and compare advertising results of both centrally managed and site managed initiatives. 6A clear recruitment plan with timeline and enrollment milestones must be developed up front so that centralized recruitment can be incorporated at the appropriate time to keep enrollment on target. By following these steps, the recruitment approach is a well-structured hybrid approach that incorporates both site and central recruitment management ensuring that recruitment results are optimized. MediciGroup Inc., King of Prussia, Pa., is a leader in patient recruitment and retention for clinical trials of medications, builds long-term client relationships by providing direct-to-patient clinical-trial recruitment and retention programs, coupled with world-class implementation. For more information, visit medicigroup.com. May 2005 VIEW on Biotechnology

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