Clinical Trials for Patients

A clinical trial is a controlled study conducted with the participation of human subjects, aimed at evaluating the safety and effectiveness of new treatment methods. It is carried out in accordance with strictly defined procedures set out in a study protocol and under the supervision of physicians and qualified medical personnel.

Each trial is conducted in compliance with applicable ethical standards, with full respect for the rights, safety, and well-being of participants. Participation is voluntary and requires the patient’s informed consent.

Every medicinal product, medical device, or medical procedure introduced to the healthcare market undergoes four phases of clinical trials.

Before a medicinal product, medical device, or medical procedure is registered and approved for marketing, it undergoes three stages of clinical trials (Phases I–III). Each of these phases has a specific objective and allows for the gradual assessment of safety and effectiveness. After registration, Phase IV studies are also conducted to further monitor performance in everyday medical practice.

• Phase I trials are conducted in a small group of healthy volunteers or patients (in the case of medicines intended for incurable diseases). The primary focus is on evaluating safety and determining how the product affects the human body.
• Phase II trials are carried out in a larger group of patients with a specific condition. This phase assesses the treatment’s effectiveness in managing the disease, its safety, and the optimal dosage, often through comparison with a placebo.
• Phase III trials involve a very large group of patients. The main objectives of this phase include evaluating safety and effectiveness, establishing final therapeutic doses, assessing adverse effects, and comparing the study results with standard treatment methods. After completion and analysis of the collected data, the product may be approved for market introduction.
• Phase IV studies are conducted after registration and market approval. They involve a large group of patients and aim to further confirm the therapy’s safety and effectiveness in routine clinical practice, including the identification of rare adverse effects and interactions with other medications.

The safety of participants is the highest priority in every clinical trial. In Poland, a clinical trial may only begin after obtaining approval from an independent bioethics committee and the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL).

Both of these authorities assess the medical justification for the study, the safety and well-being of participants, the quality of the investigational product, the compliance of the study design with applicable regulations and ethical standards, as well as the reliability of preclinical data supporting the therapy’s potential effectiveness.

A clinical trial participant is guaranteed the right to:

• receive full, reliable, and comprehensible information about the purpose, course, potential benefits, and risks associated with the study,
• participate voluntarily in the clinical trial after reviewing and signing the informed consent form,
• withdraw their informed consent at any time during the study, without providing a reason and without any negative consequences for their further treatment,
• receive free medical care related to the trial, including diagnostic tests and treatment covered by the study protocol,
• be reimbursed for expenses incurred in connection with participation in the trial,
• receive compensation in accordance with applicable regulations if they suffer harm related to participation in the study,
• have their personal data protected,
• ask questions at any stage of their participation.

Individuals who meet specific medical criteria (so-called inclusion and exclusion criteria) described in the study protocol may participate in a clinical trial. These criteria relate, among other things, to age, diagnosis of the condition, and overall health status.

All costs related to the clinical trial are covered by the study sponsor, such as a pharmaceutical company. If the patient incurs any expenses, for example travel costs, they will be reimbursed.

Absolutely. By participating in a clinical trial, a patient can receive:

• access to the latest treatments and innovative products that are unavailable or hard to obtain on the medical market,
• free medical consultations, professional examinations, and diagnostic tests,
• free care from top specialists in a private medical facility.

In the Clinical Trials FOR PATIENTS section on our website, you can find the studies currently being conducted at our center. By visiting the page for a specific study, you will find a contact form, which, when completed, allows the center to get in touch with potential participants.

Additionally, at the bottom of this page, you will find contact details for the study coordinators, whom you can reach by phone or email to express your interest in participating in a specific trial.

Yes. The medical data of clinical trial participants are strictly protected and processed in accordance with applicable laws, including the General Data Protection Regulation (GDPR). Access to the data is granted only to authorized personnel involved in conducting and supervising the trial.

The data are coded (pseudonymized), which means that in the study documentation, the participant is identified by an individual number rather than by name, date of birth, or personal identification number (PESEL).