„Any research study of a medical product involving human subjects conducted for the purpose of discovering or verifying the clinical, pharmacological or pharmacodynamic effects of that product. The purpose of a clinical research may also be to identify adverse effects of an investigated product or to assess its absorption, distribution, metabolism and excretion, in order to verify the safety and/or efficacy of the product used.”
source: ICH GCP (International Conference on Harmonisation Good Clinical Practice Guidelines), version 9 November 2016
Specjalistyczny Szpital Onkologiczny w Tomaszowie Mazowieckim (The Specialized Oncological Hospital NU-MED in Tomaszów Mazowiecki) participates in conducting clinical trials. This is an opportunity to save the lives and health of patients for whom previous therapy has not led to a cure or has not significantly improved the patient's health. Clinical trials are conducted with new or previously used drugs. The evaluation of new treatment concepts and innovative drugs in oncology during clinical trials enables the rational decision-making process for introducing new, effective cancer treatments to the market.
Clinical trial protocols are designed to ensure the safety and clinical benefit of the participants. This is overseen by bioethical committees and relevant government institutions. The therapeutic benefits of participating in clinical trials must outweigh the potential risks for the patient.
Participation in clinical trials is voluntary. Patients make this decision independently after thoroughly understanding all potential benefits and risks associated with the therapy. They have the opportunity to discuss various issues related to participation in the trial with a physician. Before joining a clinical trial, patients are required to familiarize themselves with the information contained in the "Informed Consent for Participation in a Clinical Trial" form and sign the document.
Patients participating in clinical trials can still access healthcare services funded by the National Health Fund (NFZ) as indicated for their health condition.
Participation in a clinical trial is entirely free of charge. Patients can withdraw their consent to participate in the trial at any time.
THREE PHASES OF CLINICAL TRIALS
The introduction of new oncological drugs or therapeutic methods occurs in stages, and there are three phases in conducting clinical trials. A positive outcome in each phase is necessary to move on to the next phase. Each phase must end positively for a drug to be approved for general use.
Phase I: In cases where the study concerns a new drug for a rare or incurable disease (e.g., malignant tumors), volunteers may include individuals suffering from this disease. The study group typically consists of several dozen people. The primary goal of Phase I is to preliminarily assess the safety of the tested substance. During this phase, researchers evaluate absorption, metabolism, excretion, toxicity, interactions with food, and commonly used medications.
Phase II: A larger group of participants, typically patients diagnosed with the specific disease, is involved in this phase. Phase II is considerably longer than Phase I, sometimes lasting several years. During this phase, the effectiveness of the tested drug in patients with the disease is confirmed. An analysis is conducted to determine the balance between the benefits of using the treatment and the risks of using the experimental product. If the benefits significantly outweigh the risks, Phase III trials are initiated.
Phase III: This phase is conducted on a much larger scale than the previous two phases, with up to 1,000 or more participants, including patients diagnosed with the specific disease. Phase III usually lasts from 3 to 5 years and aims to:
- Confirm the safety and efficacy results obtained in Phase II of clinical trials.
- Compare the performance of the new drug to currently used treatment methods.
In this phase of clinical trials, the effectiveness and safety of using the new drug in combination with other standard therapies are also evaluated.
If the results of the third phase of clinical trials are positive, indicating that the tested drug provides the potential for better treatment compared to currently available therapeutic approaches, efforts can be made to obtain its registration and subsequently introduce it to the market.
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