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Clinical trials are the foundation of modern medicine. They are necessary to check whether a given substance in the drug is safe, effective and better than available. Thanks to them, it is possible to discover new and develop existing therapeutic strategies, as well as explore the knowledge about the effectiveness and safety of drugs. Before each drug is available for sale, it must undergo a series of such tests.

Clinical trials have been conducted in our country since the beginning of the 1990s by research institutions, foundations and pharmaceutical companies. With the start of clinical trials, higher standards of medical care and more modern and alternative treatments began to be introduced. Bioethics committees and the Central Register of Clinical Research (CEBK) were established, later renamed the Office for Registration of Medicinal Products, Medical Devices and Biocidal Materials.

In order to protect the safety and rights of people participating in clinical trials and to ensure the reliability of the data obtained, the rules of Good Clinical Practice (GCP) were developed and implemented. These are international ethical and scientific standards for planning, conducting, documenting, and reporting the results of human drug research.

In order to start research in which the testers will be people, it is necessary to submit an application for a permit to the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products and the relevant bioethical commission. The President of the Office has 60 days to issue a decision. The study may only commence after approval by both authorities. Clinical trials are usually conducted in hospitals or medical research centers.

- They must be conducted by people with sufficiently high professional qualifications, scientific knowledge and experience in working with patients - says Wojciech Łuszczyna, PhD, spokesman for the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

The greatest number of new drugs in oncology

Most clinical trials are conducted in the United States and Western Europe.

- In Poland, the number of registered tests has remained stable over the last 10 years - about 400-500 tests are performed annually. Over 20 percentregistered research concerns oncology. Other areas of medicine that are often related to research registered in Poland are: neurology, dermatology, gastroenterology, cardiology, diabetology, rheumatology and pulmonology - says Wojciech Łuszczyna. The President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Materials keeps the Central Register of Clinical Trials (CEBK), containing, inter alia, information on the investigational medicinal product, research centers and researchers. - However, this register is not available to the public.

There is apublicly available European clinical trial registercontaining data on trials ongoing in the European Union, including data from Poland. It can be found at www.clinic altrialsregister.eu. Data in the registry comes from the European database of clinical trials (EudraCT). The research appears in the register after entering into the database information on the permit issued by the competent authority and information on the positive opinion of the relevant bioethical committee - adds Wojciech Łuszczyna.

Breakthrough discoveries thanks to clinical research

Thanks to clinical trials, today we have many new drugs and therapies, and until recently untreated diseases can be successfully treated. In 1999, only 3 in 10 patients diagnosed with leukemia survived to 5 years. Today, in many cases, treatment is effective and not only stops the progression of the disease, but also completely cures the patient.

In turn, thanks to the development of protease inhibitors and subsequent research into improving drugs and therapies, the death rate among patients with AIDS fell by 70%. Thanks to new drugs, patients after successful transplantation enjoy their saved lives and regained he alth. In the past, patients who required internal organ transplants did not have such a chance, because the immune system caused rejection of organs transplanted from unrelated donors. The research proved effective, leading to the almost complete elimination of many diseases, such as Heine-Medina disease (polio). 50 years ago, the infection with this disease was associated, among others, with with a high risk of death or permanent muscle paralysis. Thanks to the invention of the vaccine, it has been successfully contained in most regions of the world. The World He alth Organization (WHO) announced in 2002 that Europe was polio-free.

Four phases of clinical trials

Clinical trials are carried out according to strictly defined rules. The he althy and sick participants play a major role in them. Without them, it would not be possible to determine whether a given drug is effective and safe, and therefore there would be no chance of introducing itmore and more effective drugs. It is therefore crucial to ensure the safety of volunteers and respect for their rights. Clinical trials are divided into 4 phases, each of them must be successful in order to start the next phase.

The first stage of work on a substance that is to be used in medicine isthe pre-clinical phase of research . First, the compound is tested on cells in vitro (grown outside living organism under laboratory conditions), and then on experimental animals. Such a study may take up to several years. For patient safety reasons, the drug cannot be placed on the market solely on the basis of laboratory tests and animal studies. Therefore, research involving test patients is necessary.

Phase I clinical trials

Therefore, the next stage is clinical trials involving he althy people (phase I), the purpose of which is to verify or confirm the analyzes and knowledge obtained so far. During the first phase, the safety of a given substance is assessed, and several dozen he althy volunteers test its absorption, metabolism, excretion and toxicity. The interaction of substances with food and commonly used drugs is also checked.

The results of this part of the work make it possible to determine the initial dosage. Phase I trials are conducted in research centers owned by pharmaceutical companies or scientific institutions. In the case of research on substances for the treatment of cancer and mental diseases, Phase I and Phase II are combined in order not to expose he althy volunteers to highly toxic compounds.

Phase II clinical trials

The aim of phase II clinical trials is to determine whether a new drug works in a specific group of patients and whether it is safe. The relationship between the dose and the effect of the substance is also assessed, which results in the determination of the dose used in subsequent phases of the research.

At this stage of the research, the effects of the new drug and the so-called placebo, or a drug already known for the treatment of a given disease. Several hundred volunteers who suffer from a given disease take part in this phase of the research.

Phase III clinical trials

In the third phase of clinical trials, conducted with several thousand patients, it is finally confirmed whether the tested drug is effective in the treatment of a given disease. The aim of this part of the research work is to determine the relationship between the safety of the substance and efficacy during short-term and long-term use.

This part of the research may take from one to several years.

IVclinical trial phase

IV - the last phase of clinical trials concerns registered and marketed drugs. Its purpose is to determine whether the drug is safe in all indications recommended by the manufacturer and for all groups of patients.

Clinical trials - information for the patient

Joining a clinical trial is voluntary, however, it requires appropriate preparation and reflection. The physician acting as the researcher decides whether a person meets the medical criteria. It is estimated that every year several thousand Polish patients give their informed consent to participate in clinical trials of new drugs. According to the estimates of the Association for Good Clinical Research Practice in Poland, approximately 200,000 people could participate in them so far. people. For some patients, it is a chance to undertake a modern form of therapy, at the same time improving the quality of life. In addition to access to innovative therapies, volunteers are carefully studied. It is not uncommon to reveal diseases that would not otherwise have been detected.

It is worth knowing that a drug test participant has the right to information about his or her he alth condition at every stage of the research.

Any volunteer who agrees to participate in the study may, at any time, for various reasons, withdraw without suffering any consequences. He should inform the doctor about his decision and attend a check-up so that the doctor can assess his he alth after participating in the tests.

The doctor is obliged to inform the participants about new data that may, for example, influence the decision regarding further participation.

Participation in the research is free for the patient. The study sponsor will bear the cost of drugs, specialist tests, and medical care, and the cost of treating side effects.

Is participation in clinical trials safe? There is always risk

Clinical trials are subject to very detailed procedures and strict control at every stage. This is necessary to reduce the possible risks associated with conducting them for the people taking part in them.

- When planning a clinical trial, the potential risks and inconveniences should be weighed against the expected benefit for the participant in the trial and for society. The potential benefits for the individual and society resulting from its conduct must justify the risk to which the participants of the study may be exposed, says Wojciech Łuszczyna. Research participants are primarily exposed to adverse effects of the drugs tested or the negative consequences of procedures related tothe test performed. Persons who have suffered permanent he alth impairment during drug tests are en titled to compensation.

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