Safety first
The government has made research into the effects of medicines on human subjects compulsory before new medicines are allowed on the market. Before medicine manufacturers start testing on people, a great deal of research has naturally already been carried out. We can therefore predict fairly accurately what the effects will be. However, we cannot exclude everything. To reduce the risks for volunteers to a minimum, there are numerous national and international laws and regulations that are followed by PRA to the letter. Your welfare always comes first.

Support from professionals
Quality and safety start with the professionalism of the people who carry out the research. All clinical trials are supported and carried out by doctors, pharmacists, scientific researchers, nurses, and doctor's assistants specially trained for that purpose. They are experts in their field and work in accordance with strict scientific and medical-ethical guidelines.

International laws and regulations
The clinical studies of PRA satisfy all international standards, including the Declaration of Helsinki. Your participation is moreover protected by the guidelines for Good Clinical Practice and the Medical Research (Human Subjects) Act (Wet medisch-wetenschappelijk onderzoek met mensen). This law determines, amongst other things, that research must be approved beforehand by the independent Medical Ethical Committee (Medisch Ethische ToetsingsCommissie (METC)), which includes medical experts, clinical pharmacologists, methodologists, legal experts, pharmacists, nurses, and ethicists, as well as lay people.

Advance approval by the METC
The METC assesses, amongst other things, whether or not the research study is structured in a proper way and is not unnecessarily harmful for the volunteers. Furthermore, the committee assesses whether or not the safety and privacy of the volunteers are guaranteed, and whether or not recruitment has taken place in an ethically responsible way. The complete protocol for every research study of PRA, which includes a complete overview of the research activities and all the associated information, is sent to the METC beforehand for approval. Only after approval has been giving can the clinical trials start. 

Registration of a new drug
PRA works on assignment to pharmaceutical manufacturers who develop new medicines. All the test results together a form a dossier of hundreds of thousands of pages. In the Netherlands, this dossier is sent to the Medicines Evaluation Board (College ter Beoordeling van Geneesmiddelen), which decides whether or not a new medicine may actually be sold in the Netherlands. If the Board gives its approval, the medicine is officially registered and may be placed on the market. From that moment onwards it can be obtained from a pharmacist. Because the research studies satisfy all the international standards, the dossier can also be offered for registration anywhere in the world.

Insurance
People who take part in clinical trials at PRA are automatically covered by a general liability insurance policy. In addition, we take out special trial subject's insurance to cover all damage that might arise out of the research itself. This is one of the statutory requirements of the Medical Research (Human Subjects) Act. As a volunteer you must then, of course, comply with the requirements and conditions that are applicable in connection with the trials.

Risks
Naturally, you are asking yourself if taking part involves any risks. As far as that goes, we can be very clear: everything you do in life - travelling, playing sports, going out for a meal - involves certain risks. Anyone who takes part in social life always runs a (relatively small) risk that something will happen. Taking part in medical research is no exception. Our starting point is that participation in clinical trials should not involve any greater risk than the generally accepted risks that are associated with participation in social life.

What will you have to do?
The time that you spend at PRA is of course not just a series of research activities from early in the morning to late at night. You have your meals at fixed times, you have to go to sleep and get up at certain times, and you are regularly visited by members of the medical staff to take blood samples and to check your physical condition. But the rest of the time you do not have to sit around getting bored.

Leisure time
As you can see from the photo album, PRA provides plenty of leisure facilities. There is a comfy living room where you can read or watch TV. We have an extensive collection of new top DVD’s and four Playstation 3 game computers with a very wide range of games. There are also computers with internet access, and – as long as there is enough time within your research timetable – you can use the study room or occasionally take a walk outside (under supervision). In addition, there are table tennis tables, dartboards, and (in Zuidlaren) a billiard table. All in all, enough to ensure you have a pleasant stay.

Tailor-made activities
We want to replicate natural living conditions as far as possible during the trials. Useful activities are an integral part of this. If the trials last longer than one week we will therefore offer you various kinds of activities. These can range from massage or pedicure, workshops on cartoon drawing or photography, to courses on meditation. In this way we will make your days more varied, and your stay will become an enriching experience.

Other participants
Most clinical trials are carried out with a group of 5 to 12 people. Often people in the same age group: young people or conversely older people. Sometimes only men or only women. In addition, for example, there are also specific trials that are only for women in the menopause, people who are overweight, or patients with diabetes or minor forms of asthma. Whatever group you are in, you will often make friends during the trials. There are even participants who like each other so much they even agree to come back again together for another research programme!

^ Back to top