Clinical trials

A clinical trial is a study on human volunteers that serves to answer a specific medical question. Carefully and qualitatively conducted clinical trials are the fastest and safest way to discover new types of treatment and ways to improve health in people. In oncology, interventional studies are most common, which investigate whether a new/experimental treatment (or a standard treatment applied in a new way) is safe and effective under controlled conditions, and whether it is better than the currently best form of treatment. The majority of drugs and other forms of treatment used in medicine today are generally the result of clinical trials that have been conducted in which their usefulness has been confirmed. This is also the main difference between official medicine and alternative medicine that uses preparations whose usefulness has not been scientifically proven. A clinical trial is conducted by a study team consisting of a doctor, a nurse and, if necessary, other health professionals. The conduct of each study is based on a protocol, which details the clinical study plan in order to ensure the safety of the participants (patients) and the relevance of the final results. The protocol defines, among other things, the characteristics that a patient must have in order to participate in a particular clinical study, the diagnostic test plan, the procedure for administering drugs and their doses, as well as the duration of the study.

​What are the benefits and risks of participating in a clinical study? Clinical studies that are well designed and conducted are the best approach for patients who want to take an active role in their own health care and gain access to the latest forms of treatment before they become widely available. Patients can also help other similar patients by supporting scientific research by participating. Ethical and legal regulations regarding health care also apply to clinical studies, and clinical studies are subject to additional regulations that ensure that the safety of the subjects included in the study is not compromised. There are also risks, namely that the study drug (as with any standard drug) may develop side effects. The treatment may not be effective for an individual patient.

Who can participate in a clinical trial? Each individual study has specific criteria that define who can participate in it. The use of inclusion and exclusion criteria is an important principle of medical research that ensures the reliability of the final results. Factors that allow a patient to participate are inclusion criteria, while a patient who meets any of the exclusion criteria is not a candidate for participation in the study. These factors may include age, gender, type and stage of disease, previous treatment, and other medical conditions/diseases. It is important to note that inclusion and exclusion criteria are not defined to prevent patients from participating on an individual level, but to identify a group of patients who have the greatest chance of treatment success and to ensure the safety of the applied therapy. Also, well-defined inclusion and exclusion criteria allow investigators to obtain a clear answer to the question posed by the study.

Figure 1. Clinical trials are the fastest and safest way to make progress in medicine. This is how new drugs and treatments enter everyday use.

Can a participant in a clinical trial withdraw from participation after the study has begun? Yes, a patient can decide to withdraw from the study at any time. All that is required is to inform the responsible physician who is managing the patient in the study, who will record the reason for the patient's withdrawal from the study.

Who sponsors clinical trials? Clinical trials can be sponsored by a variety of organizations or individuals, such as physicians, health care institutions, groups, volunteer groups, and pharmaceutical companies, as well as some government agencies. Studies can also be conducted in a variety of settings, such as hospitals, colleges, clinics, and outpatient clinics.

​What is a control group? Many studies are conducted in such a way that one group of patients receives a new experimental drug or other innovative form of treatment, while another group receives a standard form of treatment or placebo. This second group is called the control group, and it is used to compare the results of the study drug with the current standard.

What are the phases of clinical trials? Clinical trials are conducted in phases. The initial phase of the trial is the preclinical phase, when in vitro (test tube) studies and in vivo animal studies are conducted. This is followed by the clinical phase of the trial, which can be divided into four segments (phases 1-4). In phase 1, the trial begins with a small group of healthy individuals (20-80), and if the drug proves effective, a larger and larger number of subjects are included in each subsequent phase. The process is gradual to ensure the safety of the subjects.

Clinical trials and onkologija.net. The onkologija.net team actively participates in conducting a large number of clinical trials, not only in oncology but also in medicine in general. We can offer our patients participation in a clinical trial in Croatia or abroad at no cost to the patient. Read more!

Additional interesting facts

What is a placebo? A placebo is an inactive tablet, liquid, or powder that has no therapeutic effect. In most clinical trials, a new drug is compared to the current standard of care, but if no standard of care is available, a placebo may be used. In most cases, neither the patient nor the doctor knows whether the patient is receiving the drug or the placebo, to avoid conscious or unconscious bias in the results.

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