Participants

To begin with, you might benefit from a new treatment, because this treatment may prove to be more effective than your current treatment, or have less side effects. Furthermore, during the study, you will enjoy additional medical support by our specialised team. In some cases, there are no immediate benefits for you. This will not decrease the value of your participation, because you contribute to a clinical trial that will benefit future patients.

There are multiple kinds of studies. Some will only take a day, while others can take up to eight years to complete. Prior to your participation in a clinical trial, you will be explicitly informed on the duration of the study and the number of visits to the research site that is required.

Depending on the type of investigation, several actions need to be performed. Before you participate in a study, the doctor will discuss the various steps and options. We always perform a detailed physical examination, record your medical history and measure your length, weight and blood pressure. In some cases, it may be necessary to take a blood or urine sample, do an electrocardiogram, perform an internal examination or fill out one or more questionnaires. Most of these procedures will be performed at the research site, but sometimes they need to be done in a local hospital (e.g. a mammography).

For every clinical trial, a mandatory set of participation criteria is determined. These criteria are based on age, a certain illness (e.g. high blood pressure or diabetes) and perhaps the use of a certain type of medication. It is possible that you do not meet the requirements for a certain study, but do qualify for a different one.

Yes, your GP/PHP will be informed about your participation and the results from the examination. Your medical history must be verified by your GP/PHP. Your GP/PHP can always notify our PT&R research physician, if he objects to your participation in the clinical trial, for instance due to medical reasons.

Yes, participation in the clinical trial is always completely voluntarily. You can choose to end your participation at any time. You will, however, be requested to visit us for a final examination, for instance for a blood test for safety follow up and/or to return the trial medication you have been provided.

There are risks connected to every treatment. This includes also standard treatment options. Participation in a clinical trial, however, does not put you in any higher risk than a regular treatment. Also, you are under strict supervision and a doctor is available 24 hours a day to answer any inquiries you might have.

No, there are no costs involved in participating in a clinical trial. Any travel expenses will be refunded should you choose to participate in the study. You will be reimbursed 19 ct/km for every time you need to visit the centre. The distance for the reimbursement is calculated based to the shortest distance between the postal codes. Sometimes the medical ethics committee decides to agree on an additional financial compensation. Medication is provided free of charge, as well as the examinations.

There are no consequences for your medical insurance, e.g. no additional charges. You do need to have a valid Dutch health insurance to be eligible for participation in a clinical trial at PT&R.

An independent Review Board (IRB or METC) will determine if a certain clinical trial may be conducted in the Netherlands, and who will be allowed to conduct this study. Such a committee is constructed from a group of medical and legal experts. They also determine if a stipend may be offered to the participants in a study. Generally, patients are not rewarded such a stipend for participation in a clinical trial. Exemptions are made only if an invasive treatment must be performed or if the patient is involved in the study for an excessive amount of time, a financial compensation can be offered. The height of this stipend depends on the length and burden of the study. The burden depends on the number of visits and possible discomfort. The stipend is not determined on the risk of the participation in the trial. It is based on the minimum wages, before taxes. Possibly, you may have to declare these allowances for income taxes. Allowances are only reimbursed for actual visits, if these have taken place in accordance with the study protocol. The non-binding information visit is free of charge and travel costs are not reimbursed for this visit.

PT&R is an independent research site that conducts research on behalf of and/or in collaboration with (academic) hospitals, government, pharmaceutical or laboratory institutions.

At PT&R, we employ doctors, nurses and assistants that are specialised in conducting independent clinical research. They are supported by and cooperate with an administrative staff and a management team. All data that is collected during the medical study, is treated confidentially and safely stored. The data is processed anonymously, so nobody – except PT&R employees – can determine your personal records. All PT&R employees are bound by confidentiality. PT&R is also legally bound by the Dutch Personal Registration Act.

You can contribute to a number of studies that PT&R is currently conducting. For more information, check the overview under ‘participation”. Of course, for more information, you can contact PT&R through +31 (0)85 0604 605 or send an e-mail to info@ptr.nu. You can also register for our newsletter and/ or follow us on Facebook.

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