Janssen's Clinical Pharmacology Unit (CPU) at the Jan Palfijn hospital in Merksem tests medicines, which are still in the development stage, on human volunteers. No need to say that the safety of the volunteers is our absolute priority.
Clinical trials come into the picture only after years of preclinical development in a lab. Researchers try to anticipate the risks for volunteers during lab and test animal studies. Developing a new medicine for humans is not possible without actually testing it on people, to see if the new substance is efficient and safe. You can only make assumptions by conducting tests in the lab and on animals. If a preclinical study indicates the slightest potential risk, the tests in humans will not be started.
Caution is a must
The care for the safety and health of the volunteers taking part in a clinical trial starts with the selection of participants. A general preliminary examination determines which studies you are eligible for. Before you can participate in a study, further screening and preliminary tests must be performed. Only then you can make a contribution to the medical science.
Continuous observation and measurement
Nothing is left to chance during a clinical trial. Investigators carefully and continuously monitor volunteers, and this involves lots of measuring equipment. Your blood pressure is measured, an electrocardiogram or heart film is made, your heartbeat and breathing are checked and blood samples are taken to detect chemical changes in your blood. Some employees also act as observers. They observe the volunteers, regularly ask them how they are feeling and also ask very specific questions.
The fact that the CPU is located at the Jan Palfijn hospital in Merksem is not accidental. "Risks cannot 100% be excluded in studies. Our people can obviously administer the required first aid, but it is important that we have easy access to the specialized services at the hospital", declares Maikel Raghoebar, director of the CPU. The study team is a multidisciplinary team and works independently from the hospital. But for certain studies the expertise of a specialized physician may be required. In those cases it is quite handy that specialists are at hand.
Interested to participate in a clinical trial? Read all about it and register on www.cpu.be