For patients

Clinical trials are a key element in evaluating the efficacy and safety of medical therapies. All phases of a trial are governed by Good Clinical Practice (GCP) standards to ensure patient safety and protect patients’ rights. They are essential for bringing new therapies to market.

Clinical trials have 4 phases, each with its own objectives and specific risks and benefits for patients. Each phase of the trial-from the initial safety assessment to the detailed analysis of efficacy and potential side effects-is essential for the approval and introduction of new therapies.

Patients, physicians, and all other participants in these trials, through their involvement and cooperation, contribute to the ongoing development of medicine. Through collaborative efforts, more effective, safer and targeted treatments can be provided, resulting in a better quality of life for patients around the world.

Clinical trials are conducted in accordance with strict ethical standards and regulations that are designed to protect the health and rights of trial participants. Participation in clinical trials is always voluntary, and every participant has the right to be fully informed about the trial and to withdraw at any time.As a result, clinical trials play a key role in improving healthcare, helping to bring modern and more effective therapies and drugs into clinical practice.

Participation in clinical trials is open to individuals who meet certain eligibility criteria, which vary depending on the type of trial. Candidates for participation in the study are carefully selected by assessing their age, health status, medical history, current medications and many other factors that may affect the course of the study and response to the therapy used. They also cannot participate in other clinical trials at the same time.

Participants’ health status is carefully assessed based on their medical history, test results and other important health information to ensure that participation in the study will not carry unnecessary risks for them.

Those interested in participating are always fully informed about the nature of the study, expected benefits, potential risks, study procedures and their rights and responsibilities as participants. It is important that each candidate participant is given the opportunity to ask questions and receive comprehensive answers to allow them to make an informed decision about participation.

Not everyone can become a participant in a clinical trial, but anyone who meets the selection criteria and gives Informed Consent has a chance to contribute to medical progress.

Clinical trials offer patients a range of benefits that can be difficult to access in traditional medical care. One of the most important advantages is the opportunity to benefit from novel therapies that often use cutting-edge medical advances, even before they are generally available on the market.

This opens the door to treating conditions that may have previously been difficult to manage with traditional methods. In addition, participation in clinical trials guarantees patients continuous and intensive specialized care. Doctors and the entire medical team involved in conducting the trial focus on closely monitoring patients’ conditions. In clinical trials, patients also have access to advanced diagnostic tests that are rarely used in standard care.

Such tests allow for a more thorough understanding of the course of the disease and monitoring of the effectiveness of the therapy used. What’s more, all these benefits are offered at no cost to study participants, which underscores the attractiveness of participating in such projects.

Clinical trials are designed to evaluate the safety and effectiveness of new therapies. To ensure maximum safety for research participants, the process is strictly controlled by relevant government organizations. The Ministry of Health, the Bioethics Committee and the Central Register of Clinical Trials play a key role in overseeing how trials are designed, conducted and evaluated. It is through their certification and monitoring that patients can be assured that participation in trials is conducted according to the highest safety standards.

Before participating in a trial, each patient has the opportunity to discuss all aspects of the therapy, including potential risks and benefits, with their treating physician. This is extremely important so that the study participant is fully aware of what he or she is choosing to do. To this end, the patient is given a document, called an Informed Consent Form, which contains all the necessary information about the study, its conduct and the test substance. In this way, the process is fully transparent and understandable to the participants.

Participation in clinical trials provides patients with special rights that guarantee their safety and informed participation in the process. Every participant in a trial has the right to a full and clear understanding of its purpose, methods and potential benefits, as well as access to their medical records. It is worth noting that consent to participate in the study is completely voluntary and can be withdrawn at any time, without any financial consequences.

Patients are required to arrive on time for all scheduled appointments at the center. If for some reason they are unable to attend an appointment, it is important to notify the center as soon as possible, preferably by phone. During the course of the study, patients must also strictly follow the instructions and recommendations of the attending physician, which is crucial to guarantee the reliability of the study. In addition, it is critical that the study participant keep the medical staff informed of any changes in his or her condition, newly emerging conditions or perceived side effects.

Transparency and openness in communication between the patient and the research team are key to the proper conduct of a clinical trial.

Clinical trials are subject to strict regulations designed to ensure the safety and protection of participants and guarantee the scientific and ethical quality of the research itself.

Before a clinical trial can begin, it must receive approval from the relevant institutions, such as the Bioethics Committee or the Local Regulatory Authority. Each study is based on a well-defined protocol that defines the objectives, methods and research procedures.

Participants in the study have the right to be fully informed about its aspects and potential risks and benefits, and their participation is fully voluntary. International standards, such as the Declaration of Helsinki and Good Clinical Practices (GCP), provide the foundation on which all clinical trials are based. The data collected is stored in a way that guarantees the privacy of participants, but at the same time must be available for verification by the relevant authorities.