1 Boring Old Man

This report analyzes the current state of global clinical research and the role that biopharmaceutical companies and their clinical research organization (CRO) partners play in ensuring that the dual goals of trial safety and quality are met.

• Global trials speed drug development – The report concludes that globalized trials can reduce development time by half while lowering costs and maintaining quality and safety.
• Research quality standards must be met worldwide – The report found that trials in emerging countries, such as China and India, are subject to the same standards as those conducted in the U.S. and Western Europe.
• Clinical research improves local economies – Clinical research offers huge advantages for host countries, including an influx of advanced equipment, trained personnel and high-paying jobs.
• Emerging market equals growth market – CRO activity in Central European countries, South Korea and Taiwan is very robust, medical infrastructures are advanced and capabilities are just about on par with Western Europe.

The fledgling clinical trials industry in India has been hit by recent revelations of a lack of regulation. Now, the country’s supreme court has criticised the body that oversees clinical trials for its inaction in the face of these unethical practices.

‘Uncontrolled clinical trials are causing havoc to human life,’ the supreme court stated in response to a petition filed by the human rights group Swasthya Adhikar Manch (SAM). ‘There are so many legal and ethical issues involved with clinical trials and the government has not done anything so far.’ SAM’s petition alleged that multinational companies are exploiting loopholes and gaps in the law to run their trials. Poorly run and unethical trials have resulted in health problems and even the death of some trial participants, who are often signed up without their knowledge.