|Overseas Clinical Trials: Compare and Contrast
Association of Clinical Research Organizations
Globalization White Paper
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.
With the changing landscape for CROs, the report has several key findings:
Indian supreme court’s anger over unregulated clinical trials
by Rajesh Parishwad
25 January 2013
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.
The supreme court directed the government to manage the ‘menace’ of poorly regulated trials on a war-footing. The court asked the health secretary to take over supervising clinical trials across the country, revoking the power of the Central Drug Standard Control Organisation (CDSCO) under the Drugs Controller General of India (DCGI), the sole agency that monitors and regulates clinical trials…
- the clinical research industry: time-to-market and beyond…
- the clinical research industry: the cro running in the background…
- the clinical research industry: cross purposes…
- the clinical research industry: an invisible empire…
- the clinical research industry: the ‘atypical’ decade…