August 2008 – The CenterWatch Monthly : Volume 15, Issue 6, June 2008
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...
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...
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...
- Month in Review
- In the Pipeline
- Opportunities Underway