Applied Clinical Trials
The impact of proactive subject recruitment planning.
Subject recruitment continues to be an integral part of the drug approval process and is the number one cause of trial delays. The total cost per subject for a Phase III study exceeds $26,000, according to Cutting Edge Information. These experts say the average cost to reach and recruit subjects for a research study is approximately $7600 per subject. In the subject recruitment category alone, pharmaceutical and biotechnology companies have allowed an 86% failure rate—a rate that would not be tolerated in any other industry.
Pharmaceutical and biotechnology executives rank subject recruitment as the most costly and time consuming aspect of clinical trials, yet many companies fail to take proactive steps to develop a strategic plan and specific budget for subject enrollment before the start of a research study. A few key components directly affect the enrollment rate: the protocol criteria, the research sites, and recruitment planning. The industry must do a better job of identifying enrollment obstacles and use strategic tactics and budgets in the initial planning process to assist in recruitment efforts and control costs.
Planning and budgeting before the study starts is much easier and less expensive than going back after the study is behind schedule. In a rescue situation, media costs are at a premium, with little or no time for planning and negotiation of rates. Top dollar must be paid. In addition, trial sponsors continue to pay associated internal and external study costs, including investigator fees, CRO fees, and internal personnel salaries.
In most cases, without a proactive plan, dollars have already been wasted on advertising and materials that did not work at the site level. Sponsors often allocate a lump sump dollar amount per site to be spent on media advertising and materials. This is not the most cost-effective use of recruitment budgets.
Media costs vary widely by market. For example, a newspaper ad in Dallas, TX, sells for $2500. The same ad costs $800 in Louisville, KY. A planned media campaign with the right tactics to reach the target audience is imperative.
Creative development of branded, cohesive study materials that motivate patients to respond is also key to successful subject recruitment. Consistent materials increase brand awareness and recall among potential subjects. The combination of these marketing efforts and site databases will help enroll the study on time.
Of course, advertising creative development and media buying are not the study site's specialty. The site staff's time is best utilized when devoted to screening and enrolling subjects and managing the clinical study.
Millions of dollars per day are lost due to delays in the drug development process. The industry is under tremendous pressure to streamline costs. Studies show that pharmaceutical companies that successfully reduce the drug development cycle time use proactive strategies that include subject recruitment programs.
Proper planning that includes careful analysis of the protocol, target audience, and market research will result in a recruitment strategy and budget that can be established up front to help manage costs and enroll the study on time.
Clinical trial sponsors will pay for subject recruitment. The question is simply: How much and when?
Donna Beasley is vice president of operations at Praxis