Testing times

So how does the latest life-saving drug get on to a chemist’s shelves?Testing, of course: testing in a lots of ways over a very long time.

It might be a surprise to learn that it can take around 10-12 years for a drug to be deemed ready to be released onto the market.

The drugs we trial here have already gone through extensive testing. We have seven doctors and a full complement of nursing staff to make sure that volunteers receive the highest standard of care.

First comes the laboratory testing, followed by, if necessary, animal testing. Only after those exhaustive processes do we get to first base, or Phase 1 as it’s called.

This is when humans get involved. Phase 1 tests all have to be licensed by the regulatory authority with around 300 approved every year. Human testing is carried out in three or four phases, each stage proceeded to only after the results from the previous have been fully analysed and endorsed.

Manchester is the proud host of one of the largest Phase 1 clinical research organisations in Europe, dealing with an average 700 volunteers involved in 50-60 trials every year. It’s called ICON and based in Manchester’s Science Park, well-known for its pioneering cutting edge businesses.

The company carries out trials on behalf of pharmaceutical businesses worldwide, who draw up a plan for the way things should go. Then there’s an independent scientific review which must also be rubber-stamped by an ethics committee.

So many checks and balances in fact that it’s very, very rare for unpleasant or dangerous side-effects to develop. It’s the unusual nature of such problems that makes them stand out when they happen, for instance as at Northwick Park in London in March 2006, when six men became dangerously ill.

As Brian O’Dwyer of ICON says: “I can’t comment on what happened at Northwick Park, but in general clinical trials are not to be feared. The drugs we trial here have already gone through extensive testing. We have seven doctors and a full complement of nursing staff to make sure that volunteers receive the highest standard of care.”

As an added safeguard ICON has close links with Manchester Royal Infirmary, a hop, a skip and jump around the corner. In the 20 years of operation the centre has never had to use the intensive care facilities in its near neighbour.

Volunteers are always kept fully informed of the procedures, potential side effects and so forth. As a payment to cover time off, volunteers can receive sums of up to £3500 These figures are arrived at through the ethics committee to ensure that volunteers aren’t in effect bribed onto the test.

Yet volunteers have an invaluable role to play. If we are to find new remedies and cures for the health problems of the future we must have human testing facilities such as ICON.

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