Participation in clinical trials
You can only take part in one of our research studies after extensive medical screening and various other compulsory formalities. See also the section on participation. If all these conditions are satisfied, then you can take part in one of the clinical trials that we offer you, but the final choice is up to you.
Checking in
All studies are carried out in our clinics in Groningen and Zuidlaren. On arrival you will be welcomed by the staff of the clinic. You will get to meet the other participants and be taken on a tour of the ward. If you would like to get a first impression now, you can take a look at our photo album on this website. During the introduction, you will receive more information about the house rules and the research programme. For example, there are often fixed times for taking blood samples and medical tests, but also for sleeping, getting up, and eating. After the tour, there is an initial short examination to make sure nothing has changed since the preliminary screening. If all results are as expected, then the trials can begin.
The administration of the medicine
The trials start with the administration of the medicine being researched, which might be in the form of capsules, a drink, a drip, or cream. During the trials, the medical staff will continually monitor the response of your body to the medicine. We will monitor the effect of variations in dosage, and repeatedly examine your blood and urine. Naturally we will also monitor your vital bodily functions as well: temperature, respiration, blood pressure, and pulse rate. In addition, we try to keep the use of jabs for the taking of blood samples to a minimum, for example by placing a cannula (Venflon©) in your arm. This is a drip needle that can stay in place in the vein over a longer period so that we can take blood without having to use a jab, see also the explanation in the FAQ. Nonetheless, for certain tests it will also be necessary to still use a jab to take blood samples in other places.
Other tests
The conditions of your stay can vary depending on the drug being tested. For example, you might need to stay lying down for certain period periods, either long or short, or conversely stay sitting up. Sometimes extra tests are necessary, such as lung function tests. However, you will have been informed about this during the medical screening, and this will therefore not come as a surprise. Each research study is carried out in accordance with fixed, very precise, written rules: the protocols. We can therefore explain to you exactly what will be expected from you before the study begins.
Effects and side-effects
Depending on the type of drug being tested, you may experience desirable or undesirable effects. With anti-coagulation medicines, for example, a wound may temporarily continue bleeding somewhat longer, or you might get bruises more easily for a time. This is a side-effect that we can predict in advance. Furthermore, side-effects might occur of the type described in the information leaflets that accompany medicines. For example, you might feel nauseous, tired, or dizzy, or suffer from diarrhoea. That is why we ask you to continually tell us about how you feel and will take any complaints extremely seriously. Our doctors and nurses are trained to identify very precisely any effects that occur. At the end of the day, that is the fundamental purpose of the trials. At the slightest indication that the side-effects are too strong, you will be withdrawn from the trials immediately.
Post-screening
Approximately three weeks after the end of the trials, a follow-up examination, so-called 'post-screening', will take place. We want to be absolutely sure that there are no residual effects, and that you leave the clinic just as healthy as when you arrived. We often do a number of tests and blood samples are taken. We will also ask you detailed questions about your experiences, including any complaints after your visit to the clinic, so that we can continually improve our research. This examination will conclude your participation in the research study. The results of the post-screening tests will be available after three days. If everything is normal, then you will not be contacted. Should the tests reveal something unexpected, then we will ask you to come back to the clinic for an additional follow-up examination.
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