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What is a clinical trial?
A clinical trial is a scientific study, conducted with human subjects, to discover or confirm the clinical, pharmacological, including pharmacodynamic effects of one or more investigational medicinal products.
Clinical trials are also conducted to identify adverse effects and to follow the absorption, distribution, metabolism and excretion of one or more investigational medicinal products with a view to their safety and efficacy.
Clinical trials are conducted according to strict rules, the aim of which is to ensure maximum safety for the patient (trial participant) and respect for their rights. It is the physician acting as the investigator who decides whether the patient meets the medical criteria to take part in the trial. The rules for conducting clinical trials are governed by existing legal and ethical acts.
source – Medical Research Agency website.
Our aim is to give patients access to state-of-the-art therapies,
while keeping them safe and caring for a better future.
Why should I take part in a clinical trial?
Before starting the treatment process as part of the clinical examination, your health condition will be carefully assessed. Based on the medical history taken and the results of the tests ordered, you will be qualified for therapy.
As part of each study, the patient has access to…
If you start treatment as part of a clinical trial, you can withdraw at any time. You then enter a post-treatment observation period. You are under the care of a specialist – free of charge – until the trial ends.
Qualification stages
Below are the 5 key steps for qualifying to join a clinical trial.
Submitting the application form: Start by completing the application form on the Ginemedica website to register your interest in participating in a clinical trial.
Conversation with the coordinator: After submitting the form, the coordinator from the center will call you and then discuss the details of the examination with you and answer all your questions.
Visit with the attending physician: Then you will be scheduled for an appointment with the attending physician, who will discuss in detail the purpose of the study, the risks and benefits of participation, and conduct an initial assessment of your health condition.
Signing Informed Consent: Once you have understood all aspects of the study, you will be asked to sign informed consent to participate in the study.
Diagnostic tests: After signing the consent, the so-called period will begin. screening, during which you will undergo a series of diagnostic tests to confirm your qualification for the test.
Frequently asked questions
Yes, you can withdraw from the study at any time without providing a reason. There are no legal or financial consequences for doing so. However, it is important to inform the lead doctor of your decision, as they may suggest alternative treatments and ensure your safety.
No, participation in a clinical trial is completely free. All visits, diagnostic tests, and medications are covered by the study sponsors.
Your health is closely monitored by doctors and medical staff. Regular visits, lab tests, and other diagnostic procedures help track your well-being and detect potential side effects at an early stage.
Yes. Every clinical trial is approved by relevant institutions, such as ethics committees and the Office for Registration of Medicinal Products. Tested substances undergo rigorous testing before being allowed in trials involving patients.
Clinical trials are designed for individuals who meet specific criteria, such as having a certain condition, being in a specific age group, or meeting health requirements. Each study has different qualifications that are assessed during the screening process.
The schedule of visits depends on the specific study. In some cases, visits occur every few weeks, while in others they may be more frequent. You will receive a detailed visit plan before starting the study.
The duration of the study depends on the specific project. It may last several months or even a few years. You will be provided with detailed information about the timeline before joining the study.
Patients participating in Phase II and III clinical trials do not receive compensation, only reimbursement for travel expenses to the clinic. Currently, we conduct only Phase II and III trials at Ginemedica.
Access to innovative therapies before they are officially introduced to the market.
Comprehensive diagnostics and specialist care.
The possibility of improving health when standard treatments do not yield the desired results.
Contributing to medical advancements and helping other patients in the future.
Yes, your data will be protected in accordance with GDPR regulations. Personal information is anonymized and used solely for research purposes.
