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Clinical trials
Drug trials: A booming business

CBC News Online | March 15, 2006

A large and growing industry has sprung up around clinical trials.

When the lab mice have done their bit, when the computers have crunched the data, when the last test tube has been emptied – the only way to be reasonably sure a new drug works safely in people is to have humans try it.

Every year, thousands of Canadians volunteer to be human guinea pigs by participating in clinical trials. The vast majority pass through the process unscathed, but in rare cases a trial can go wrong, with serious consequences.

» From March 15, 2006: Severe drug reactions from British drug trial leave 2 in critical condition

Clinical trials are studies conducted on humans and their interaction with new drugs, treatments and vaccines. The trials are carefully crafted to answer specific questions about the effectiveness of new therapies, or to find out more about specific diseases and ailments.

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Montreal has the largest number of clinical trial organizations of any city in North America.

With large pharmaceutical companies scrambling to be the first to market with the latest concoction to cure or treat society's ills and pains, it's no surprise that new, experimental drugs have quickly become the mainstay of the clinical trial industry.

Before a company can put a new drug on the shelves, it is required to conduct a roster of studies to ensure the medication is safe and effective for patients. The results of those studies are then handed over to Health Canada as part of the company's application to have the drug approved for sale.

And while the pushing of pills is inarguably big business for big pharma, a large and growing industry has also sprung up around clinical trials.

Just a couple of decades ago, most drug trials were publicly funded. Now, companies that conduct drug studies are popping up, paid by pharma giants to conduct the studies and help navigate the regulatory process.

According to Industry Canada, spending on research and development by the biopharmaceutical industry, estimated at $33 billion worldwide in 2001, is growing by 15 per cent per year. Approximately 40 per cent of that goes towards clinical trials.

Of that, an estimated $1.3 billion is spent per year on recruitment for the trials ($1 billion on patient and $300 million on physician recruitment.)

All told, the cost of developing and launching a new drug is estimated to be between $659 million and $800 million US.

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In Canada, a clinical research nurse/clinical research associate with two to four years experience can expect to make between $25,000 and $32,900 US. A comparable nurse in a U.S. hospital or clinical site stands to earn $50,000 - $60,000 US.

(Source: Industry Canada)
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Canada's Food and Drugs Act: Regulations Amending the Food & Drugs Act - Clinical Trials

Good Clinical Practice Consolidated Guidelines – International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use

Guidance for Clinical Trial Sponsors: Clinical Trial Applications – Health Canada
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