CenterWatch Monthly September 2008 Issue

Tuesday, September 9, 2008 01:00 PM

Central and Eastern Europe: Growth Opportunities, Growing Pains

Given the uneven length of global clinical trial experience in CEE countries, many industry insiders consider that the region has both emerging and “emerged” countries. Growth is expected to continue generally in the CEE region, perhaps more quickly in the largest countries, such as Russia and Ukraine. CRO opportunities are many in Central and Eastern Europe. Global CROs made three major acquisitions between the end of October 2007 and mid April 2008, and that trend should continue. More protocols in the major centers are driving increased competition for sites and clinical research personnel and pushing CROs outside metropolitan research centers to more regional sites.

No Fazing Phase I Growth

Phase I studies have become more complex as drug sponsors want critical data about their compounds to help inform decision-making and avoid expensive late-phase failures. For CROs that offer early phase services, the future looks good. Demand for outsourced phase I work is increasing at a 13% to 15% rate, slightly higher than the 12% growth rate reported last year.

CRAcademy Offers New CRA Training Model in Europe

As most industry insiders will acknowledge, the clinical research employment market has undergone a shift—on a global scale—from being employer-driven to candidate-driven. Difficulties finding and keeping qualified clinical trials personnel in Europe and elsewhere have grown. Observers agree that the available workforce simply isn’t large enough to meet staffing needs. Experienced and inexperienced professionals alike are capitalizing on the clinical research industry’s staffing shortfalls.

Eye On: Allergies

Allergic reactions are defined as abnormal, excessive responses of the immune system in response to an otherwise harmless, foreign protein known as an allergen. Individuals who are genetically predisposed to a specific allergy or to multiple allergies mount an immune response via lymphocytes, immunoglobulin E (IgE) antibodies, inflammatory mediators and mast cells. This results in symptoms involving the target organs, namely, the nose, eyes, bronchial tubes, skin and gastrointestinal tract.

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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