CenterWatch Monthly August 2008 Issue
Central and Eastern Europe Triples Global Trial Participation
The number of global clinical trials initiated in Central and Eastern Europe more than tripled from 2002 through 2007. While the entire CEE region has less than half the population of either India or China, it had more than twice the number of global trials initiated last year as all of the Asia-Pacific region. With the growth of the CEE region has come increased advantages and challenges. Costs have increased, but access to large treatment-naïve populations due to centralized healthcare systems offsets them. Though the EU Clinical Trial Directive was implemented in 2004, there is no uniform regulatory process that governs the entire region, and each country also has its own local culture, so local site management is important.
As Trial Results Reporting Deadline Looms, Confusion Grows
On Sept. 27, 2008--one year after implementation of FDAAA--the so-called “basic results” reporting provisions become effective.The law requires that basic results from clinical trials of all FDA-approved drugs or devices be submitted to ClinicalTrials.gov no later than one year after the primary completion date of the trial. The deadline has pharmaceutical companies scrambling not only to comply with the requirement, but also to get clarity from federal regulators.
GCP Regulation in Europe in 2008
In an era in which business regularly complains about EU regulation, the clinical research community’s attitude to Good Clinical Practice (GCP) makes a refreshing change. Both the regulations and the inspectors who enforce them in this area have gained and retained the respect of the industry they regulate, including the 2005 EU Directive on GCP.
Eye On: HIV/AIDS
Infection with the Human Immunodeficiency Virus (HIV), if left untreated, is followed by development of the Acquired Immune Deficiency Syndrome (AIDS). HIV-1 infection leads to progressive destruction of certain immune system cells, known as CD4+ cells, resulting in the state of immune system dysfunction known as AIDS.
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