„… clinical trials in Poland, as in more developed countries, are a valuable addition to the generally available diagnostic and therapeutic process and set the pace for medical progress.”
Dr hab. Mariusz Korkosz
The idea of clinical trials. Why are they so important?
Nowadays, evidence-based medicine – medicine based on facts – is the basis for an effective and safe therapy. Thanks to having a drug developed on the basis of preclinical studies, whose pharmacokinetics and pharmacodynamics have been verified in healthy volunteers in phase 1 studies, at a dose selected during phase 2 studies on a small group of patients suffering from a given disease, we have the opportunity to check its effectiveness and safety during phase 3 studies conducted on a large group of patients, which was selected so as to resemble as closely as possible the patient population in which the drug will later be used.
Participating in Clinical Trials – Patient Benefits
Participants in clinical trials are individuals for whom standard therapy does not work. Importance is placed on chronically ill patients, especially oncology patients. For such people, participation in trials is often the only chance to receive medications that are difficult to obtain or not reimbursed in Poland and to benefit from diagnostic or treatment procedures that are not recommended by the National Health Fund. It is also worth mentioning the greater access to the care of the leading doctor and other specialists, which allows to clarify any doubts patients may have and to diagnose multiple abnormalities in their condition. In addition, patients increasingly mark their contribution to the development of science, especially when the study concerns family diseases, as their participation in the study may have an impact on an effective therapy for their loved ones.
Reliability of clinical trial data
Multicenter prospective clinical trials with patient populations of several thousand provide the most reliable information. Research sites are selected based on their experience in treating the disease in question, and clinical trials themselves are conducted according to a protocol created by world experts in the field. All data collected during the program are constantly checked by IT systems in the so-called risk-based monitoring mode, as well as by impartial clinical research monitors who control the compliance of applied procedures with the rules of good clinical practice.
Clinical trials at medical conferences
Medical conferences often present results of clinical trials that result in specific therapeutic recommendations. The very methodology and practice of conducting clinical trials are not widely available to physicians outside the research community, so they sometimes raise concerns and are met with misunderstanding by practicing physicians. Meanwhile, the primary care physician can play an important role in them, both by recommending his or her patient to participate in a clinical trial and later, by collaborating with the investigator. In this way, the physician who cares for the patient daily will not cause a breach of protocol resulting in the patient’s exclusion from further participation in the trial.