ABOUT CLINICAL TRIALS – MORE BROADLY
One of the tasks carried out by our Institution is to conduct clinical trials at the request of the sponsors of these trials, that is – most of the time – pharmaceutical companies interested in launching a new drug on the market or in further research on the already registered medicine.
The study of the effectiveness of various treatment options has been known since the beginning of civilization. The oldest – perhaps the oldest – example of a trial using a control group, comes from the Old Testament, in which an experiment comparing two types of diet was mentioned.
Together with the development of the community, research methods were perfected, prioritizing the safety of the patient. This condition is still the most important aspect of any clinical trial.
In 1020, a Persian physician Avicenna, announced in The Canon of Medicine, the principles of experimental use and testing of drugs, in which he determined, among other things, that the experiment must be carried out for a specific disease with the participation of man. To this day, these principles are the basis for modern clinical research.
There are many examples from the history of medical experiments, such as:
- Dr. James Lind’s attempt in 1747 to indicate the effectiveness of citrus consumption in the prevention of scurvy,
- a trial by Thomas Graham Balfour in 1894 using the belladonna extract in the prevention of scarlet fever,
- the results of a trial evaluating the efficacy of streptomycin in the treatment of tuberculosis published in 1948 by the Medical Research Council in the United Kingdom.
In recent years, we have been observing the dynamics of the increase of the number of conducted clinical trials in the world. Undoubtedly, it can be said that progress in modern therapies is impossible without the development of clinical trials.
There are also increasing requirements for centers where medical experiments can be conducted. During the qualification of an Institution for clinical trials, a number of factors that influence the quality of trials are assessed. Always the guiding principle is to ensure the safety of patients participating in the trial. The selection is a long-lasting process and not because of the tardiness of interested parties, but because of the complexity of the process.
At the very beginning, the center/institution is chosen. Then the verification of the so-called Principal Investigator of the center is carried out, whose undoubtedly the most important task is to ensure the safety of patients participating in the study. It is the Principal Investigator who takes care of patients in a comprehensive way – qualifying them for the trial, then monitoring their health during participation in the study and usually also after its completion.
At the very beginning of the clinical trial, the Principal Investigator is responsible for proposing the trial to patients who meet all the criteria, for the purpose of ensuring the safety of patients participating in a given medical experiment.
Still, the patient who wants to participate in the clinical trial and receive the treatment, must independently and consciously agree to participate in such a study. It is worth mentioning that patient’s consent can at any time and at any stage be withdrawn, even without disclosing the reason for it. Also, the Principal Investigator may, at any time, withdraw the patient from the study if he / she considers that his / her further participation in the study endangers his / her health.
After the patient agrees to participate in the study (the patient personally signs and dates, approved by competent institution, consent for the participation in the study), the so-called screening process begins. It may be a bit burdensome for the patient, however its purpose is to evaluate patient’s current health status. During this process, a number of tests are conducted, including laboratory tests. Both Principal Investigator and the sponsor need to make sure that the patient is safe in the study, as far as possible.
If the patient qualifies for the study, he or she starts receiving the study medication. The appointments are carried out according to a strictly set schedule, which we always consult with the patient.
One of the most important aspects of the patient’s participation in the clinical trial, in addition to receiving the study drug, is continuous monitoring of patient’s health status. During the follow-up visits, we perform the procedures provided for in the trial protocol, such as, for example, physical examination, neurological examination, vital signs control, standard and highly specialized laboratory tests, functional tests, magnetic resonance imaging and Positron-emission tomography (PET testing). Their range and schedule vary between clinical trials. Finally, the patient has the opportunity to ask the doctor questions and discuss his/her current state of health.
What is very important is that the tested medicine and the clinical trial activities are free of charge. In the event of an unexpected deterioration in the state of health, the patient is subjected to standard medical procedures.
Participation in the study is free of charge, but also the patient – for legal reasons – does not receive any remuneration for it. The only expenses that may be reimbursable are the travel expenses for visits related to the clinical trial (reimbursement is guaranteed in accordance with the consent for the clinical trial signed by the patient and by the doctor). In justified cases, with the approval of the bioethical commission and the sponsor – the patient can be reimbursed for the cost of meals and accommodation associated with visit related to the clinical trial.
As already mentioned, the Principal Investigator is the physician directly responsible for the clinical trial in the center. The PI is a specialists in the field concerned, who is carefully selected by the center, and his qualifications are verified in detail by the sponsor of the research. The Principal Investigator is in charge of the research team. All members of the research team must have appropriate qualifications, confirmed by certificates, which must be guided by ethical standards and renewed periodically.
There are a number of documents whose principles guide the activities of our Center. They have been specified in documents such as:
- Regulation of the Minister of Health of 16 February, 2016 on detailed requirements for planning, conducting, monitoring and documenting a clinical trial of a medical device,
- Good Clinical Practice,
- Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine
- The Nuremberg Code,
- The Declaration of Helsinki,
- The Belmont Report.
It is now planned to extend the therapeutic areas of our clinical trials to include internal diseases, dermatology, psychiatry and rheumatology.
We invite interested patients to contact our Institution.