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Wednesday, March 2, 2011

Clinical Trial

Clinical trials are a step in Medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g., drugs, diagnostics, devices, therapy protocols)

Depending on the type of product and the stage of its development, investigators enroll healthy volunteers and/or patients into small "Pilot Studies" initially, followed by larger scale studies in patients that often compare the new product with the currently prescribed treatment

Clinical trials usually borne by the sponsor who may be a governmental organization, a Pharnaceutical or Bio-Technology company.Often a clinical trial is managed by an Outsourced Partner such as a  Contract Research Organisation (CRO) or a clinical trials unit in the Academic Sector.

The Clinical Trials Registry- India (CTRI) has been set upin 2007 by the ICMR's National Institute of Medical Statistics (NIMS) and is funded by the Department of Science and Technology (DST) through the Indian Council of Medical Research (ICMR)

The CTRI is an online register of clinical trials being conducted in India. Any researcher who plans to conduct a trial involving human participants, of any intervention (drug, surgical procedure, preventive measures, lifestyle modifications, devices, educational or behavioral treatment, rehabilitation strategies and complementary therapies) are expected to register the trial in CTRI before enrollment of the first participant. 
The CTRI encourages the registration of all clinical trials conducted in India before the enrolment of the first participant. “The registry is meant to bring transparency to clinical trials conducted in India
Though the launch of the CTRI marks a new chapter in the clinical trial registration process in India, there are daunting challenges ahead. Since its launch in 2007, 64 clinical trials have been registered, but there is still no legal obligation to register.

According to the Associated Chambers of Commerce and Industry, an influential national industry association, India is set to grab clinical trials business valued at approximately US$ 1 billion by 2010, up from US$ 200 million last year.Drug companies are drawn to India for several reasons, including a technically competent workforce, patient availability, low costs and a friendly drug-control system


436 killed in Clinical Trials in 2012

As many as 436 people died last year due to serious adverse events (SAE) during clinical trials. Investigations are now on to ascertain how many of the deaths were caused by drugs administered to the trial subjects.

Ghulam Nabi Azad,Union Health Minister said on Friday Feb 22,2013 that deaths could be due to life-threatening diseases such as cancer, heart failure and stroke or side-effects of the drugs or their administration to critically or terminally-ill patients. "Such deaths are investigated to arrive at the causal relationship, if any," Azad said in parliament.

In 2011 438 cases of SAE were reported, of which 16 were found to be due to clinical trials. The previous year, 668 cases of SAE were reported, of which 22 were caused due to trials.

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