Atopowe zapalenie skóry u pacjentów dorosłych
Łuszczyca u pacjentów dorosłych
Wrzodziejące zapalenie jelita grube u pacjentów dorosłych
Access to modern treatment methods, which are commonly inaccessible for other patients or they are very limited because of financial reasons. TREATMENT WITHIN CLINICAL TRIALS IS ALWAYS FREE
You are under medical care of experiences specialists in a given field, with 24h contact.
Systematic free diagnostic tests which enable regular health assessment of clinical trials participants.
Close monitoring of treatment procedures.
Direct contribution in development of modern therapies and medicine.
1. Obtaining a consent from both the independent Bioethics Committee and the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products is a necessary condition for starting clinical trials..
2. Trials are carried out only in specialized and approved centres, where the Principal Investigator is mainly responsible for their execution.
3. The course of the whole trial with details is included in the trial report, which is the main document and on the basis of it all procedures and the whole process of treatment are carried out.
Every clinical trial participant before any procedure has to give informed consent for participation in the trial. During the process of obtaining your consent you will be provided with detailed information on the whole clinical trial, risk and benefits of participation, requirements of visits according to the trial report. You will also have the opportunity to ask questions and we will try to answer them in the most detailed and understandable way.
Giving a consent for participation in the trial does not guarantee a participation in the trial, but just starts the process of qualification. During your first visit, depending on the requirements of the trial report, there will be some initial procedures carried out, which aim at confirming qualification criteria e.g. medical examination, detailed interview concerning basic disease and medical history, considering current treatment, collection of blood, urine or faeces sample for lab tests, measurement of life parameters (pulse, pressure, weight, height), ECG etc.
The process of qualifications usually lasts from 1 to 4 weeks. You will be informed about results by phone. In case of meeting all necessary criteria, you will be invited to an appointment starting the trial. During this appointment the process of treatment also usually starts. Since this time, you are under our close medical care (we are available for you 24h a day). The length of treatment depends on the clinical trial and it is precisely described in the trial report, usually it is a period from a few months to a few years.
The time for next appointments is set according to the trial scheme. In most cases, it is set also according to your preferences, although due to some restrictions, it can be difficult sometimes (especially during holidays).
During the trial and after it, you have full access to your lab test results, imaging results or other diagnostic procedures. At the end of the trial, we try to summarize the whole process of treatment with a patient and compare the initial medical condition with the present one, on the basis of additional test results and physical examination.
Free consent of a patient for participation in the trial is necessary. A patient has a right to refuse to participate.
A patient has a right to all information connected with his / her participation in the trial.
A patient has a right to withdraw from a clinical trial at any time without giving a reason, this decision will not influence the process of treatment other than the clinical trial.
A patient has a right to information about his / her health condition at any moment of the trial.
A patient has a right to protection of his / her personal data.
A patient has a right to information about all new data concerning the tested medication, which may have influence on his / her decision about the trial.
In case of any infringement of rights or inadequate execution of them, a participant has a right to contact with the COMMISSIONER FOR PATIENTS’ RIGHTS THROUGH FREE HELPLINE 800-190-590 OR AT THE ADDRESS: OFFICE OF THE COMMISSIONER FOR PATIENTS’ RIGHTS UL. MŁYNARSKA 46 01-171 WARSAW
Every clinical trial is covered by compulsory civil liability insurance.
Insurance details are included in the Information about the Trial and the Informed Consent Form, which you will be familiarized with and you will get a copy for you during your first visit.
Participation in every clinical trial is always free.
Usually there is also a possibility of getting a refund of additional costs such as costs of travel for visits. All detailed information you will get during your first visit in the centre.
During your first visit in our centre you will get all necessary information concerning the clinical trial. If you agree to participate in it, we will probably have a visit qualifying for the trial.
Sometimes you may be asked to come on a different day, because of the necessity of fasting or performing additional tests, which we do in other centres etc.
It is important to take for the first appointment all medical documentation, not only concerning the main disease. The physician conducting the qualification has to familiarize in detail with all your medical history. It is a very crucial element of the qualification, because it may happen, that your health condition or medical history will not allow for qualifying for the clinical trial.
You will also be asked to provide information about all medicines you take and you took in the past (a few past weeks).
The exact names of the medicines, doses and frequency of taking will be necessary.
During the visit you can be accompanied by close people, who you would like to take your decision with.
The first visit usually lasts not shorter than 1 hour, sometimes even up to a few hours. During the arrangement of the visit, a coordinator will give you detailed information.