Earlier this week in the New York Times, they shed light on some of the issues facing GlaxoSmithKlien and their clinical research outsourcing in China and how they're facing issues with quality control. Author Katie Thomas points out the fact that they're currently entrenched in a bribery and corruption scandal which centers in their research and development center in Shanghai.
When audited, it was found that:
...researchers did not report the results of animal studies in a drug that was already being tested in humans, a breach that one medical ethicist described as a “mortal sin” in the world of drug research. They also concluded that workers at the research center did not properly monitor clinical trials and paid hospitals in ways that could be seen as bribery.
There were situations where the results in animals weren't reported and drugs had already made their way to human testing, failing to properly use the animals as a guage for how safe the drug will be in human trials. In a second audit, it was questioned whether or not patient safety was properly monitored and site monitors were in question as to whether or not they were actually monitoring the number of patients they were being paid to supervise. Since then, GlaxoSmithKline has made a vow to correct and prevent these issues in the future and stated:
Glaxo said it had since tightened the payment procedures for clinical research coordinators. Referring to the current bribery investigation, the company said, “we have zero tolerance for any kind of corrupt behavior among our employees, suppliers and business partners and will take action wherever and whenever we find it.”
This fall at Partnerships in Clinical Trials Asia, we bring together some of the most experienced experts in clinical outsourcing to learn and share their experiences on conducting clinical trials in the Asia Pacific region. Professionals from Bayer Healthcare, EISAI, Coviden, Merck, Sanofi Aventis and more to join us and discuss issues like these in the region. For more information on the program, download the agenda. If you'd like to join us, as a reader of this blog, when you register to join us in Shanghai and mention code XP1875BLOG, you'll save 15% off the standard rate.
How can companies learn from GSK and prevent these types of issues in the future?
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