Trend Of Outsourcing Trials to China, India Raises New Ethics Questions
This article was originally published in PharmAsia News
The trend by multinational pharmaceutical companies conducting clinical trials in China, India and other nations with emerging economies may be upsetting accepted ethics of trials. Viral Genetics, a U.S. biotech, came under criticism when it conducted a trial of an AIDS drug in China by giving a control group a placebo instead of antiretrovirals, the accepted trial behavior in the Western World. Chinese authorities investigated after several AIDS patients died during the trial, and concluded "no serious violation of ethical principles." That incident highlights increasing concerns over quality, research ethics and lives of patients in outsourced trials. (Click here for more - may require a subscription
You may also be interested in...
A package of health proposals intended to build up the EU’s resilience to health threats while strengthening the competitiveness of Europe’s pharmaceutical industry and ensuring access to affordable drugs takes a major step through the legislative process this week.
Hikma has pushed back against a further attempt by Amarin to counter its US generic version of Vascepa, this time via a fresh lawsuit claiming that the generic induces infringement of patents protecting cardiovascular indications for which the brand is approved but which are carved out of the generic label.
The European Medicines Agency will continue working over the Christmas period so that it can complete its assessment of the newly filed marketing applications for BioNTech/Pfizer’s and Moderna’s COVID-19 vaccines as soon possible.