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CenterWatch Monthly December 2007 Issue

Monday, December 17, 2007

Asia-Pacific Countries Set for Global Clinical Project Leadership

With more than 30% of the world’s population, Asia-Pacific is becoming an integral part of global drug development, and in the future will take a leadership position on some global projects. After 50% growth between 2005 and 2006 in the Asia-Pacific region’s new global clinical trials initiated by pharma and biotech, intense competition for talent has resulted. As sites conduct more clinical trials, 38% or more of sites in the top four respondent countries to CenterWatch’s survey of the Asia-Pacific region believed that EDC would best prevent future delays.

Avandia Warning Spurs More Drug Safety Services

In the wake of reports questioning the safety of popular diabetes drug Avandia, contract research organizations were already seeing increased demand for work involving drug safety even before the FDA revised the black box warning on the drug’s label last month. In September, the FDA Amendments Act of 2007 was passed. It gives the FDA new authority to improve drug safety. The legislation marks a significant change in the FDA’s authority to monitor safety concerns post-approval.

CROs Still Expanding Eastward in Europe

The clinical research market in Central and Eastern Europe (CEE) has been growing steadily in the past five years, and contract research organizations are continuing to expand their presence there. CEE is still the emerging region with the greatest number of new global trial initiations, according to CenterWatch analysis. In fact, the number more than doubled between 2002 and 2006.

Eye On: Hypertension

Hypertension, or chronic elevation in blood pressure, is defined as a systolic blood pressure (SBP) above 140 mmHg and/or a diastolic blood pressure (DBP) above 90 mmHg. For patients with diabetes and chronic renal disease, treatment goals are more rigorous, namely to reduce SBP below 130 mmHg and DBP below 80 mmHg.

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