For patients and participants
Each patient who participates in a clinical trial becomes a participant in a clinical trial.
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About the research clinical
A rich collection of information that should be read by every patient who wants to broaden their knowledge of clinical issues.
According to the definition in Poland: a drug is a substance that can be given to a man to treat a disease or disorder, to eliminate a disease or disorder, it can also be used for diagnostic purposes or to change the physiological function of the body, e.g. in menopause, aging processes.
Each drug must act in a strictly defined way, it is described in the 'Summary of Product Characteristics'. The manufacturer of the drug and the registration authority are legally and compensated for the fact that the drug bought by us in the pharmacy works as it should.
Information on how the substance need to be used as a medicine is collected during a long process consisting of preclinical and clinical trials. This process is very closely supervised by law and Bioethics Commissions.
After obtaining all the necessary information, the production company starts the registration process. Registration of the substance as a medicine and its admission for sale is supervised by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Poland. The final decision is issued by the Minister of Health.
The list of medicines that can be used in Poland is the Register of Medicinal Products Authorized for Trade on the territory of the Republic of Poland. It is updated twice a year from the Registration Department of Medicinal Products, Medical Devices and Biocidal Products.
While searching for a new drug to provide help in a case of a specific disease or symptom, researchers first wonder how it should work. Then all substances that can work in the desired way are analyzed by means of computer simulations, their structure is “adjusted” to build appropriate places on the cell, in order to find a substance whose molecules are able to connect with the cell to which they are going to interact.
In the next stage, these experiments are continued on isolated cells to confirm the effect of the test substance. And also on some other cells of the human body that may come across, in order to rule out its negative effects.
When a suitable molecule is found that does not affect negatively any isolated cells of the human body; it is tested in the conditions of a living, “acting” organism, then the test substance is administered to animals. If the results show that the test substance is safe, it goes to the stage of clinical trials.
At each stage of the search from many hundred or many thousands of substances tested, only a few pass to the next. The preclinical stage lasts on average about 4-5 years.
If the effectiveness and safety of the test substance has been confirmed in the preclinical stage – it is safe for people to take it. The purpose of the evaluation of the impact of the test substance on the human organism is carried out in four phases:
Phase 1. The substance is taken by a healthy young men in order to check the safety of the substance and its action in the human body, because it may turn out that the human body reacts differently than animal organisms. In this phase the potential participants are paid, because they exist difficultness to determine the risk, and the participants as healthy people have no opportunity to benefit from it.
Phases 2. and 3. During these phases the test substance is taken by people with a disorder/disease to treat the test substance, the effect of the substance is compared to the drugs available on the market, the best dose is determined, whether a given substance is more powerful than the drugs used so far. As well the safety and side effects are observed. The test substance will be registered as a medicine if it is more effective and safer than the previously used.
Phase 4. A phase that lasts after registration of the test substance as a medicine, when it is already available in pharmacies, where side effects are still observed, and besides, the action of different doses and forms of drug delivery, e.g. tablets, capsules, drops are compared.
The main essence of clinical trials is to compare the test substance with the previously used drugs.
Clinical trials are conducted using the "double-blind" method, which means that neither the trial participant nor the physician conducting it knows which of the substances being compared; one of the drugs or placebo used so far, or a test substance. These substances are allocated to the participants of the study at random, it is called randomization.
This method is used to ensure that the results of the study are not affected by any conscious or unconscious emotions or expectations of the researcher or participant associated with any of the substances.
In order for a test substance to be registered as a medicine, it must be concluded from the results that it is more effective and safer than the one with which it was compared.
After completing a clinical trial, we receive a new drug that is safer and more effective than the ones used so far. The whole process of its formation lasts from about ten to several years.
All information found on the leaflet of the medicine purchased at the pharmacy was obtained during clinical trials.
When planning a clinical trial sponsor, i.e. a pharmaceutical company; the manufacturer of the future drug determines the objectives of the study and how it is performed by constructing the so-called Test report. It also prepares an accurate description of the test substance, take in it the results of all pre-clinical and clinical tests, which it contains in the so-called Investigator's brochure. These documents are subject to assessment by a specially designated organization - FDA / Food and Drug Administration / in the USA and / or established at the European Parliament EMEA / European Medicines Evaluation /. After obtaining its approval, the sponsor organizes a network of clinical research centers that will conduct the study, either alone or by means of one of the companies created for this purpose. Such a network must consist of centers in many different countries to check the effects of the substance in different climatic, nutritional, etc. conditions.
During the organization of a clinical trial in Poland, the organizing company must obtain the approval of the Bioethics Committee taking into account the well-being and safety of participants in clinical trials and the Central Register of Clinical Trials.
The Bioethics Committee supervises the study throughout its duration, gathers information about serious side effects (SAEs) that occurred during its course.
The sponsor collects data on the participants' health status from all centers on an ongoing basis. These data, after statistical treatment, indicate whether the test substance proved to be more effective and safer than the drug with which it was compared.
At the end of this process, the sponsor announces the results of research. Sends to the centers a data “deblocking” the test, i.e. information, which substances used in the study were accepted by every participant in the study.
The center and the doctors who are to conduct the clinical trial must also be approved by the Bioethics Committee and the Central Clinical Research Registry. After obtaining this approval, the documentation of the study flows into the center and all persons participating in the conduct of the study: doctors, coordinators, nurses and lab technicians undergo training, depending on the scope of responsibilities, regarding the study protocol, the activity of the test substance and drugs used in it, collection and documenting data.
All apparatus used in the study must have appropriate certificates.
After checking by the representative of the company the research, the center gets permission to include its participants in the study. The number of participants in a given study depends on the sponsor’s decision, determined by various factors.
Each participant, if they does not finish the study prematurely, on their own or researcher’s decision, they take part a specific number of visits (set out in advance).
After the last visit of the last participant and the collection and transfer of all medical data to the sponsor, the center’s study is closed. The center archives the history of the participants’ disease.
After completing the entire program, the center receives “blinding” data, which is made available to former participants of the study. They are important for the assessment of individual reactions to medicines and may influence the future decisions of doctors as to the choice of therapy.
Before granting permission for conducting a clinical trial in our country, the Ministry of Health submits them to the Office of Registration of Medicinal Products, Medical Devices and Biocidal Products, the Central Register of Clinical Trials (CEBK) that controls the compliance of audit documentation with legal standards.
After the consent for conducting the study has been granted, already during its duration the CEO of the said Office has the possibility of controlling the research by the help of the Clinical Trial Inspection; among other things, the application of the Good Clinical Practice standards, compliance of the test with the protocol, correctness of record keeping, etc.
Throughout the study, the Central Bioethics Committee also has insight into it, gathering information about side effects that occurred with its participants, analyzing any changes to the protocol and other documents determining the way the research, thus ensuring the safety of the participants.
The Bioethical Commission also supervises the course of the study at the level of the center, in this case it is its field department appropriate to the location of the center.
The representative of the Pharmaceutical Inspectorate has access to the treatment of medicines and medical substances.
The principle rule is a constant control of the way the research is carried out and the data are collected by the representative of the company organizing the so-called monitor. It is also possible for the sponsor to conduct special visits aimed at quality control.
The center can also be audited by representatives of various organizations: the research organization, the sponsor, the Clinical Trial Inspection, as well as the audits carried out by the FDA.
If necessary, the Ombudsman for Patients’ Rights will also have access to the conducted examination.
Legislation regarding Conducting of Clinical Trials
All legal regulations related to Clinical Research can be found at:
The GCPpl Association we are a member of, constantly updates the information contained therein.
Polish law absolutely requires that every participant taking part in a clinical trial has to be insured against the negative effects of taking the test substance. This is included in the Ordinance of the Minister of Finance of 30 April 2004 on compulsory third party liability insurance for the researcher and the Sponsor, as amended.
Just as the drug manufacturer takes responsibility for any negative effects of its action not included in the "Summary of product characteristics" (see "WHAT IS A MEDICINE" tab), so the sponsor - the producer of the test substance is responsible for its action.
A prerequisite for registering the study in Poland (see the tabs 'STAGES OF CLINICAL STUDY' and 'INSTITUTIONS SUPERVISING CLINICAL STUDY') is the presentation in CEBK of the so-called "Sponsor and researcher policy", purchased at an insurance company by the sponsor, which strictly determines the number of insured participants in the study in Poland. This may be the reason for not being able to include another participant in the study.
A copy of this policy is located in each research center. Each participant of the study may become familiar with its content.
Every doctor, including of course a doctor conducting clinical trials, is obligatorily buying out a third party insurance policy covering any claims; the cost of treatment, the cost of compensation for patients who have suffered health damage as a result of their incorrect decisions. Because, according to Polish law, clinical trials are not a patient's treatment, because they use no medicine (see the "WHAT IS A MEDICINE" tab) and the test substance; this insurance is limited to a limited extent during the clinical trial.
Therefore, our center has a special third party policy, covering the same scope as policies regarding medical activity, but operating in the field of clinical trials.
Patients planning to participate in a clinical trial must meet certain requirements. The patient receives a print of the so-called “Information for the clinical trial participant and the informed consent form”, in order to get acquainted with the course and objectives of the study, the characteristics of the test substance and test procedures, and the requirements set for him.
It is absolutely necessary for the patient to agree to participate in the study before performing any of the test procedures. Only at this point he becomes a PARTICPIANT OF THE REASEARCH.
The basic requirement for a participant in a clinical trial is his consent to provide medical data for statistical analysis, these data are, of course, guarded – patient’s personal data is not shared.
In order for the data for statistical analysis to be repeatable, all participants must report for visits at equal intervals between visits, which determines the rigid – within a few days, dates of visits.
Each participant of the study is obliged to provide the investigator’s physician with complete and reliable data on his or her health status and medications, both before and during the study.
Questions and answers
Before you receive a substance help in a disease You are suffer from, while participating in a clinical trial, you will be carefully and very specifically diagnosed. The doctor who take care of you during the clinical trial must be sure that you do not have any disease that you have not been diagnosed with before, and that you have no condition to which the substance used in the study might interact with, for example, increase the slight in blood pressure, cause the lack of respond on the drugs you are taking.
All the results of tests carried out during the clinical trial will be available to you with a possibility to pass them to the doctor leading you.
If the previous tests turned out to be effective and safe, you will receive a medication generally used in case pf your illness or as a test substance. It may also happen that you will get a placebo – an inactive substance that does not affect the body.
In each of these cases, you can feel better, worse or not feel any changes, as in any commonly used treatment.
If you do not enjoy the health benefits of participating in the study, the doctor, in consultation with you, will present you other further treatment options.
If you suffer from a chronic disease in which the available treatments have turned out to be incomplete or insufficient, you can try to get help by taking one of our clinical trial.
Fill the contact questionnaire – name or your pseudonym, phone number and contact or e-mail address.
We will contact you as soon as possible. During a telephone conversation, you will be asked to provide more detailed information about your health condition.
The decision about your participation in one of our studies will be made by a specialist after a personal contact.
Our clinical trial center is under a strict supervision of the relevant authorities, subject to all required legal regulations. You can read about them through the information on our website; “About clinical trials”.
Each participant of our clinical trial for the entire duration of the clinical trial remains under the strict control of a specialist doctor.
At the beginning of our study, every patient is subjected to an accurate diagnosis.
The final decision on whether you will take part in the study will be made by a specialist doctor conducting this study based on the inclusion and exclusion criteria specified in the study.
There is no guarantee that your health will improve during the test, but if you do not take health benefits from the research, you can give up your treatment at any time, the operator of the flowerbinder is constantly monitoring your health and if you decide that you do not benefit from the participation in the study, he will turn it off after getting your approval (we will offer you to end your participation in the study).
Your Personal Data
By contacting us, we only need your name / pseudonym / telephone number and additionally your residence address code.
We provide your personal data only to your personal doctor, which are always under a medical confidentiality.
The participant in our clinical trial may be a person with a relevant disease, which is covered by a specific examination, for example a disease for which the sponsor – a pharmaceutical company is looking for a new, more effective and safer treatment.
Often only people in a specific phase of the disease or with a specific severity can participate in the study.
All limitations of participation in a clinical trial are important for obtaining data suitable for statistical processing and, above all, for the safety of the participant.
The participant’s safety is an important subject for the sponsor; persons receiving drugs whose interaction with the test substance is unknown or disadvantageous to the participant, people with an additional disease which may be adversely affected by the test substance, or any disease whose course is unstable and can change the possible treatment, can not be part of the study.
These and many other health restrictions will be included from the treatment sponsor in the exclusion criteria of the study.
A very important limitation that every participant of the study must consent to, is to refrain from becoming a parent during the treatment, and sometimes also for a time after the treatment, determined by the sponsor. The effect of any substance on the conceived child cannot be precisely defined and the threat cannot be completed.
The inclusion and exclusion criteria are carefully evaluated during the initial consultation by the investigator – the investigating physician – he / she makes the final decision about the participant’s ability to take part in the study.
The first visit to our Center may seem astonishingly long. We want to take care of you and a detailed interview and numerous procedures are necessary to provide you with the best possible care. The first visit is usually time-consuming and rarely takes place on an empty stomach. Our doctor will inform you when you should stay on an empty stomach, so do not get tired of coming to us without breakfast. Remember to take your reading glasses or contact lenses in case of using them.
At the first visit in our center, the doctor will provide a specialist consultation. We need to collect all necessary information about your disease. Before coming to us, prepare the following information:
– collect available documentation regarding your illness (also hospital discharge, diagnostic test results, etc.). If possible, ask your doctor for a copy of your medical records – as a patient, you always have the right to do it, but sometimes you will have to wait several days or pay for the photocopying – then cost will be refund from us.
– be prepared that the doctor will ask you for the following information (therefore it is better to have the documentation already prepared):
+ date of diagnosis,
+ previous treatment (it’s important to know the dates),
+ operations carried out (including those not related to the disease).
– prepare a list of all medicines currently being taken – the doctor will ask you not only about the name of the drug, but also the dose, when you receive it and for what reason.
If you decide to participate in the study, remember to inform your doctor about as well about later appearing diseases, new medicines and hospital stays. It is very important for us, so we can take care of you properly.
Current Clinical Trials
Check what tests we conduct in our facility.