What are clinical trials (clinical drug programs) and what are the benefits of participating in them?

Research is underway to find effective drugs for many chronic autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus or ankylosing spondylitis. Clinical trials are currently one of the most promising ways to develop effective drugs for many chronic autoimmune diseases.

What are clinical trials? Clinical trials are medical research trials aimed at verifying that new treatments are safe, effective, and perspective. Clinical trials are therefore key to discovering new and novel treatments for diseases, as well as new ways to detect, diagnose and reduce the risk of disease development, as they provide crucial insight into data that cannot be collected In other ways.

Being able to participate in clinical trials is very beneficial as the patient gets access to new treatments before they become widely available to others. Participation also shows a more proactive approach to taking care of your health. Moreover, medical examinations provide the patient with comprehensive medical care by highly specialized doctors.

It is vital to remember that at NZOZ Lecznica MAK-MED, the health and safety of the patient during the clinical trial is supervised by a highly qualified researcher - a doctor whose skills and experience history are verified before the approval of the clinical trial by the Bioethics Committee and competent authorities. For the MAK-MED team, the patient's safety and health are a priority. Hence, when deciding on clinical trials, each patient is provided with specialist advice and support during the trial, excellent medical care and transparent


Clinical treatments in MAK-MED

Since 2005, our medical center, NZOZ Lecznica MAK-MED, has been cooperating with the largest pharmaceutical companies and international organizations that promote and evaluate drugs used in rheumatology. We mainly research biological drugs, which are currently practically the only effective method of treating rheumatoid diseases.

The aim of the clinical trials, apart from the assessment of the effectiveness and safety of new drugs, is often to determine the economic benefits of using the most expensive biological drugs already registered for the budgets of countries of the EU or the USA. Citizens of these countries, treated even with expensive drugs, which are very effective and safe, do not demand social funds for chronic care, but quickly return to normal life, to work, earn for themselves and can contribute to the state budget with taxes.

For a Polish patient, participation in clinical trials is not only his contribution to the progress in medicine, but also a chance for innovative and effective treatment of the disease, which, unfortunately, in many cases is almost unavailable by other means.
We perform a series of detailed tests for each patient to determine their condition and disease activity. Regular medical visits and check-ups performed during the program are an added value to participation. The patient does not incur any costs in connection with the participation in the clinical trial. He may also apply for reimbursement of costs related to travel to the clinic (train ticket, Taxi, statutory mileage for traveling by car).

A patient signing consent to participate in a clinical trial has the right to withdraw it at any stage without incurring any consequences. His participation in such a program is voluntary at any time.

Our center regularly undergoes checks, audits, and inspections to confirm the compliance of our procedures with the international law of Good Clinical Practice (ICH Good Clinical Practice). According to ICH, the overarching principle of our work is care for the law, safety, health, and well-being of our patients. They override the interests of science and companies or international organizations commissioning research. Independent institutions protecting the well-being and safety of clinical trial participants are the following: the Polish government (Office for Registration of Medicinal Products, Medical Devices and Biocidal Products), the American government (Food and Drug Administration, FDA) and the European Medicines Agency (EMA), the control of which was subject to our center in the years 2016-2020.


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