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12 Nov 2012

Pharma firms choosing to run more phase-IV trials

The number of voluntarily initiated phase-IV clinical trials has increased in recent years, a study has found.

There has been an increase in the number of phase-IV clinical trials being initiated voluntarily by pharmaceutical companies, new research shows.

Phase-IV trials are sometimes required by regulators after a new drug or medical device has been launched.
But an increasing number of pharmaceutical companies are recognising the benefits of phase-IV trial data and are initiating them of their own accord, according to research firm Cutting Edge Information.

The company's study found that 82 per cent of drug manufacturers' post-marketing trials are now started voluntarily, compared with just 61 per cent in 2006.

Meanwhile, the percentage of post-marketing trials that were required by regulatory bodies fell from 39 per cent in 2006 to 17 per cent in 2011.

David Richardson, research manager at Cutting Edge Information, said that the increase in voluntarily initiated phase-IV trials "points to a trend where pharma companies have taken greater control of their futures".

He added: "The bottom line is safety. Health outcomes and pharmacoeconomic data is more important than ever before."

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