Human Drug Testing: Risks and Benefits of Being a Test Subject at CHDR

‘Test subject’, that sounds a bit like ‘guinea pig’. Many people are hesitant to lend themselves to this. Because what if something goes wrong? “We cannot guarantee that everything will run 100 percent smoothly; it simply involves unknown resources,” says Koos Burggraaf. He is director of the Center for Human Drug Research (CHDR), a Dutch non-profit foundation that conducts drug research in Leiden.

“But what we can do – and we do – is identify the risks as accurately as possible,” he continues. “This does not completely rule out unpleasant side effects, but you minimize the chance of them.” Furthermore, every study must be approved by a recognized Medical Ethics Review Committee.

If there are any side effects, they are usually harmless things like a headache, dizziness or a bruise after the blood test. According to Burggraaf, serious side effects only occur a few times a year.

“And that doesn’t mean that those people will end up in hospital, it just means that we consider the side effect serious enough not to administer the drug to others until we have found the cause. Permanent injury or worse is really very rare. In the Netherlands I do not know of a single case in the past ten years.”

There is a lot to research in laboratories and on laboratory animals, but products intended for humans will eventually have to be tested on humans. Burggraaf: “There are also significant biological differences between monkeys and humans. No model is as good as man. Test subjects are therefore indispensable.”

At CHDR alone, several thousand people are needed each year to test potential drugs. This concerns both healthy volunteers (phase 1) and patients (phase 2). For example, test subjects are currently being sought for a new painkiller, a new antidepressant and a new drug for the treatment of psoriasis.

In order to minimize the risks, only experts who are continuously trained work at CHDR. Investigations often take place internally, at the CHDR clinic in Leiden. Subjects are first given a very low dose of the substance to be tested, and that dose is gradually increased. This way you can see whether the drug is safe at the effective doses. Participants are under constant expert supervision by doctors and nurses, and you undergo an extensive medical examination before and after the examination.

What are people’s motivations for participating in drug research? There are people who are curious and just want to experience it, Burggraaf knows. There are people who do it to contribute something and there are people who do it for the money. Incidentally, the amount of compensation you receive for a study has no connection with the level of the risk, as some people think.

“Of compensation increases as a study takes more time or is more stressful for the participant,” explains Burggraaf. “If you receive a new drug and a tube of blood is taken from you five times, it is less stressful than if you have to stay with us in the clinic for three days and blood is taken twenty times.”

The money CHDR earns from research is reinvested in the organization. Burggraaf: “We are not only interested in the possible side effects of a drug, but also whether it does what you would expect based on the animal tests. That is quite difficult at that stage of the research. In healthy volunteers you normally cannot measure whether a drug will have any effect on sick people.

We develop advanced methods with which we can measure this. Consider, for example, a way to temporarily simulate diabetes in healthy volunteers, so that we can see what the effect is on real diabetics. This sets us apart from many other institutes.” In addition, the CHDR trains the drug researchers of the future. “This is how we make a social contribution.”

By participating in drug research, you make an important contribution to the future treatment of diseases and disorders, and therefore to a better life for patients. Everyone is of course free to participate or not. But this is the main reason for most test subjects to sign up.

Knowing more? View on the website For more information.