There have been a number of reports of six men who are seriously ill after participating in a drug trial at a hospital (Northwick Park) a mile or so from where I used to live (see links).
For the researchers on the drug, this is the most devastating news you could hear. A large number of scientists will have been working for a few years trying to identify a new chemical that would lead to the potential to save someone’s life, to potentially cure one form of cancer, but instead, the news is that their drug candidate has put six people in intensive care. In many ways, it’s like being so close to your dream only to crash at the last hurdle in getting there.
What could have happened? Well any number of things. It could be anything from faulty manufacturing to an unknown process in the body being triggered. The truth won’t be known for a while. But any reaction to a drug of this magnitude is rare.
Drug trials are complex and are associated with stringent regulatory procedures. There is a predefined process to ensure that when a drug reaches market that it is both safe and effective against the condition for which it is prescribed. For that you need tests.
When a new molecule is chosen as a drug candidate, it first goes through pre-clinical trials. These are usually tested on animals (usually mice trials) first to ensure that the molecule works as it should in that mouse and that it is safe. Of course, the reason for doing this is exactly to try to prevent what happened at Parexel’s trials in Northwick Park. It also provides the benefit of predicting if the drug will be successful over the intensive (and very expensive) clinical trials to come.
Once it has passed your pre-clinical trials (and the candidate is registered), it enters clinical trials, of which there are three main phases. Phase I, the trials that these six men were in, are general safety trials. The drug is given to participants who are normal and do not have the condition that the drug targets. These trials try to identify safe doses of the drug candidate and ensures that there are no harmful effects. Sadly, in this case, they failed, and failed in a dramatic way. Rare, as most failures are for symptoms a lot less than this.
If your drug passes phase I, it then is carried into phase II and phase III trials, where the drugs are tested in actual patients for efficacy. Then, if the results are good, the results are submitted by approval by the regulatory authorities in the US (the FDA) and the EU (EMEA), as well as other countries and following approval a launch on the market. It’s a long process, as these clincal trials can last up to 8 years or even more in some cases.
A number of companies such as Parexel, who ran these trials, and Quintiles, who have a location in Guy’s Hospital in London, are generally regarded experts in the clinical trials fields, conducting thousands of trials around the world at any one time. I have no doubt that it is the expertise of the staff that may have save the lives of the six volunteers.
The perils are that drug trials are necessary, but in all cases, we don’t know what happens with the drug in humans until Phase I trials. And whilst most trials are safe, rarely do we come across a failure as serious as this. It may be cynical to suggest, but some may regard the trials to have served their purpose in this case and saved many more lives in the future if the drug had been released on the market.
But for all of this it is simply bad luck for those involved in the trials. Our best wishes to them for a speedy recovery.
Links:
BBC NEWS report
NewScientist
Wikipedia: Clinical Trials
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