As the industry continues to expand, and strains to meet ever-more challenging timelines and budgets, the state of the art in patient recruitment remains an urgent topic. But 2008 promises to be a period of continued exploration of how to find appropriate patients as efficiently as possible. We foresee the continuation of four trends.

1. Concentrating Expertise

We are watching the growing popularity of centers of excellence dedicated to patient recruitment. Upper management has realized the importance of patient enrollment and the magnitude of knowledge required to carry it out. Fortunately, best practices in recruitment have been documented by experts in the field and can support institutionalizing recruitment knowledge.

2. Multivariate Country Selection

Conducting studies outside of North America, especially in those countries with treatment-naïve patients, was once viewed as a silver bullet to increasing enrollment. It is still important. But the industry has recently shown evidence of approaching country selection for global studies more strategically, looking at both commercial objectives and recruitment objectives to pinpoint regions of the world where they will conduct studies.

Sponsors are not simply going to India, for example. They are seeking our guidance to understand and weigh recruitment criteria country-by-country against business objectives to determine which are the optimal countries in which to conduct a trial.

3. Integrating Data

Understanding the power of recruitment data, and gaining the wisdom to know how to use it, has never been more important. 2007 was a big year in patient recruitment—for both identifying which data should be tracked and for identifying the best sources of that data. Such data may originate in systems for interactive voice response, electronic data capture or clinical trial management.

BBK’s own patient recruitment management system (PRMS), offered by affiliate TCN e-Systems, allows sponsors to notice when a plan is not effective in real-time, allowing them to make mid-course corrections to aid recruitment. The schematic here illustrates the types of data that can be incorporated into a PRMS.

How A PRMS Gathers Data

If a PRMS is compatible with existing systems and adoption advances quickly (weeks, rather than months), the benefits can be enjoyed in the short term. Study teams using the PRMS are getting more than a tool; they’re getting years of patient recruitment knowledge telling them the right questions to ask, and what actions to take when the system provides answers to their questions.

4. Microtargeting

Sophistication of geographic data collection, filtering and modeling technology is crucial. In terms of recruitment, 2007 was the year that more sophisticated technology was developed to more accurately pinpoint (down to the city block) where patients live. This is how technologically sophisticated sponsors will find the correct patients for a particular study.

By collecting, analyzing, and filtering a variety of reported data, technology can identify where patients reside according to specific protocol criteria; not just the therapeutic category of the study. As this technology is used more frequently, and expands into more regions worldwide in 2008, it will provide opportunities for more strategic identification and selection of both investigative sites and advertising/media decisions. 

.(JavaScript must be enabled to view this email address) has 20 years of experience in the clinical research field and currently leads BBK’s and TCN e-System’s data management function. .(JavaScript must be enabled to view this email address) heads BBK’s Emerging Markets & Services group, bringing ideas to the industry that accelerate on-time study enrollment. Cohen and Wolf have been widely published in industry trade journals and are engaging speakers and trainers in the field of patient recruitment.