Making sure people really understand the risks involved in things they elect to do is not easy – but it is essential, says Alison R. Sammut
Communicating risk is not to be taken lightly and it becomes even more difficult when circumstances put the issue under the spotlight.
Having recently undergone major surgery, I clearly remember the pre-op consultation when the surgeon reassured me that excessive bleeding, which could lead to death, was such a minor risk that it was not even worth considering.
One week on, the guilt on his face was unmistakable.
I had actually come very close to losing my life and he was standing by me trying to raise my morale by pointing out how lucky I was to be still alive. The risk was certainly documented to be very low, and later I also found that never in his well-established career had this surgeon encountered such an incident. So what he told me pre-op was not a case of reassuring me because he believed the operation was the best solution to my problem despite the risk involved. He really and truly believed that the risk was minimal.
Communicating risk is a huge responsibility and those who take it on should do so with caution. In March, everyone was riveted to the media, when six young healthy men were left fighting for their lives at London’s Northwick Park Hospital after a drug trial went wrong. That drug trials are risky is common knowledge, otherwise they would not be held and new drugs would immediately be made available. But those with a vested interest in not putting people off participating in drug trials have been stressing there should be no such life-threatening risk in a phase one clinical trial - the first trial on humans.
Before this, extensive testing would have taken place on animals. Clinical research companies require participants to sign a consent form before a drug trial begins. But how well do participants actually understand the risks and how clearly are these communicated to them?
Are such forms riddled with medical terms? Are participants taken through the form on an individual basis to ensure they understand the known risks?
Most probably the signing of such consent forms has more to do with trust and a feeling that “it won’t happen to me” than an in-depth understanding of what might happen. Unfortunately a much-needed financial reward might also flaw the participants’ judgement. Parexel is the company which conducted the March trial.
In the “What’s in it for you” section of its website prospective participants are tempted by money, food, digital TV, a pool table, videogames, a DVD player and “now FREE internet access!” It seems more like an advert for a holiday to me!
Despite the recruitment tactics, the indispensability of drug trials cannot be underestimated. All of us use medicine in one form or another. Thus we need those who like the six young men are willing to take risks so that new drugs can be put to the ultimate test of a human trial.
Will the March incident put people off? Apparently as yet it has not. Ensuring that participants make an informed decision is vital and ultimately those communicating what risks they are up against should be applauded too, as, if taken seriously, it is no easy task.
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