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Major Restless Legs Study Completes Enrollment With Support From MediciGlobal
Date:3/31/2009

KING OF PRUSSIA, Pa., March 31 /PRNewswire/ -- Successful and seamless completion of clinical trial enrollment requires careful forecasting of screened to randomized patients, market research, an effective recruitment strategy, and project management guided by real time metrics.

MediciGlobal's President and CEO Liz Moench notes: "This is achievable when clinical trial sites are engaged and motivated to meet timelines." She adds, "We had great team chemistry with the study sponsor -- a major Pharma company -- and clinical trial sites were highly enthusiastic about the recruitment program. They were supported by a very experienced MediciGlobal team."

Restless Legs Syndrome (RLS) involves an irresistible urge to move the legs (medically known as akathisia). It is estimated that 7% to 10% of the general population is affected by RLS and 60% of cases are inherited. A serious and common side effect is sleep disturbance.

The recruitment campaign encouraged those diagnosed with RLS and sleep disturbance to seek out the clinical study. An education based approach reached undiagnosed RLS sufferers. Furthermore, MediciGlobal engaged study sites and the RLS community in the development of materials from the start. This ensured that materials were designed for maximum effectiveness.

RLS affects adults of all ages. It is twice as common in women as in men. While more prevalent in adults older than 60 years of age, about 18% of RLS patients are between the ages of 40 to 60, and 7% between 20 and 40. Every clinical study offers unique characteristics, challenges and opportunities. Since the clinical trial spanned all age groups, the recruitment campaign required a segmented approach. Each direct-response strategy used was carefully tracked for performance and cost effectiveness.

The integrated yet segmented recruitment campaign generated considerable interest, yielding nearly 55,000 web hits and click throughs to the online study screener. The project team paced advertising to each study site, in order to ensure that site staff could handle the workflow and no RLS patients were lost in the screening process.

"The team approached this project in a non traditional way," says Moench. "The sponsor was open and willing to fresh ideas and marketing techniques, and clinical trial site enthusiastically embraced them. The results speak for themselves."

This clinical study builds on a long term relationship between the study sponsor and MediciGlobal, where many recruitment programs for a range of therapeutic areas have been successfully implemented.


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