Enrollment musts	March 2009

by Colette Pilkus

Pharmaceutical and biotechnology companies are becoming more proactive and planning for the long term when it comes to patient recruitment for clinical trials. These proactive companies are using program-level recruitment planning, which takes the clinical program for a particular compound in a particular therapeutic area and planning for enrollment of the trials as a program, rather than on a protocol-by-protocol basis.

Executives with patient recruitment company Praxis Communications Inc. believe that program-level patient recruitment and brand strategy offers advantages to the sponsor such as maximized awareness, integrated enrollment, cost savings, and intelligent design.

“Implementing strategic program-level recruitment plans enrolled studies more quickly at less cost,” says Chris Layfield, director of marketing at Praxis (gopraxis.com). It’s an all encompassing approach that forces strategic planning and focus on reaching the long-term goal.”

Praxis recently provided patient recruitment services to a major pharmaceutical company for a study to test an investigational medication for a women’s health indication. The recruitment program saved 10 months off the enrollment period and delivered a 450% return on investment for the sponsor. Praxis’ centralized recruitment program directly delivered 62% of all patients randomized into the study. This was the second in branded series of studies for this indication.

Praxis also managed the first study for this indication, which saved more than 13 months off the enrollment period and delivered a 370% return on investment for the sponsor. For the second study, Praxis was able to increase the screening rate by 22% compared with the first.

The study was centrally managed and patient recruitment results were available using PraxisDirect. PraxisDirect allows Praxis, research sites, and sponsor partners constant access to analyzed study data and results. The data is compiled in the central location and managed on a site-by-site basis. With this management technology, Praxis analyzes site performance along with the recruitment program results to evaluate the efficiency of outcomes, ultimately resulting in allowing the company to more effectively manage the sponsors’ money.

Through Praxis’ analysis of metrics and data, a customized marketing strategy and extension of the brand campaign was developed to successfully motivate women to respond. Each element of the recruitment program was branded with a consistent look, feel, and message, using strategic schedules of radio, magazine, and online advertising. Praxis executives believe that the combination of multiple communications and media influenced the audience to generate the necessary response.

“The need for branded continuum campaigns is something Praxis has been on the leading edge of,” says David Fox, president and CEO, Praxis. When executed successfully, this approach adds a whole new level of success for our sponsor partners and in the end that is our ultimate goal.”