While searching for a new drug to provide help in a case of a specific disease or symptom, researchers first wonder how it should work. Then all substances that can work in the desired way are analyzed by means of computer simulations, their structure is “adjusted” to build appropriate places on the cell, in order to find a substance whose molecules are able to connect with the cell to which they are going to interact.

In the next stage, these experiments are continued on isolated cells to confirm the effect of the test substance. And also on some other cells of the human body that may come across, in order to rule out its negative effects.

When a suitable molecule is found that does not affect negatively any isolated cells of the human body; it is tested in the conditions of a living, “acting” organism, then the test substance is administered to animals. If the results show that the test substance is safe, it goes to the stage of clinical trials.

At each stage of the search from many hundred or many thousands of substances tested, only a few pass to the next. The preclinical stage lasts on average about 4-5 years.

If the effectiveness and safety of the test substance has been confirmed in the preclinical stage – it is safe for people to take it. The purpose of the evaluation of the impact of the test substance on the human organism is carried out in four phases:

Phase 1. The substance is taken by a healthy young men in order to check the safety of the substance and its action in the human body, because it may turn out that the human body reacts differently than animal organisms. In this phase the potential participants are paid, because they exist difficultness to determine the risk, and the participants as healthy people have no opportunity to benefit from it.

Phases 2. and 3. During these phases the test substance is taken by people with a disorder/disease to treat the test substance, the effect of the substance is compared to the drugs available on the market, the best dose is determined, whether a given substance is more powerful than the drugs used so far. As well the safety and side effects are observed. The test substance will be registered as a medicine if it is more effective and safer than the previously used.

Phase 4. A phase that lasts after registration of the test substance as a medicine, when it is already available in pharmacies, where side effects are still observed, and besides, the action of different doses and forms of drug delivery, e.g. tablets, capsules, drops are compared.

The main essence of clinical trials is to compare the test substance with the previously used drugs.

Clinical trials are conducted using the "double-blind" method, which means that neither the trial participant nor the physician conducting it knows which of the substances being compared; one of the drugs or placebo used so far, or a test substance. These substances are allocated to the participants of the study at random, it is called randomization.

This method is used to ensure that the results of the study are not affected by any conscious or unconscious emotions or expectations of the researcher or participant associated with any of the substances.

In order for a test substance to be registered as a medicine, it must be concluded from the results that it is more effective and safer than the one with which it was compared.

After completing a clinical trial, we receive a new drug that is safer and more effective than the ones used so far. The whole process of its formation lasts from about ten to several years.

All information found on the leaflet of the medicine purchased at the pharmacy was obtained during clinical trials.

When planning a clinical trial sponsor, i.e. a pharmaceutical company; the manufacturer of the future drug determines the objectives of the study and how it is performed by constructing the so-called Test report. It also prepares an accurate description of the test substance, take in it the results of all pre-clinical and clinical tests, which it contains in the so-called Investigator's brochure. These documents are subject to assessment by a specially designated organization - FDA / Food and Drug Administration / in the USA and / or established at the European Parliament EMEA / European Medicines Evaluation /. After obtaining its approval, the sponsor organizes a network of clinical research centers that will conduct the study, either alone or by means of one of the companies created for this purpose. Such a network must consist of centers in many different countries to check the effects of the substance in different climatic, nutritional, etc. conditions.

During the organization of a clinical trial in Poland, the organizing company must obtain the approval of the Bioethics Committee taking into account the well-being and safety of participants in clinical trials and the Central Register of Clinical Trials.

The Bioethics Committee supervises the study throughout its duration, gathers information about serious side effects (SAEs) that occurred during its course.

The sponsor collects data on the participants' health status from all centers on an ongoing basis. These data, after statistical treatment, indicate whether the test substance proved to be more effective and safer than the drug with which it was compared.

At the end of this process, the sponsor announces the results of research. Sends to the centers a data “deblocking” the test, i.e. information, which substances used in the study were accepted by every participant in the study.

The center and the doctors who are to conduct the clinical trial must also be approved by the Bioethics Committee and the Central Clinical Research Registry. After obtaining this approval, the documentation of the study flows into the center and all persons participating in the conduct of the study: doctors, coordinators, nurses and lab technicians undergo training, depending on the scope of responsibilities, regarding the study protocol, the activity of the test substance and drugs used in it, collection and documenting data.

All apparatus used in the study must have appropriate certificates.

After checking by the representative of the company the research, the center gets permission to include its participants in the study. The number of participants in a given study depends on the sponsor’s decision, determined by various factors.

Each participant, if they does not finish the study prematurely, on their own or researcher’s decision, they take part a specific number of visits (set out in advance).

After the last visit of the last participant and the collection and transfer of all medical data to the sponsor, the center’s study is closed. The center archives the history of the participants’ disease.

After completing the entire program, the center receives “blinding” data, which is made available to former participants of the study. They are important for the assessment of individual reactions to medicines and may influence the future decisions of doctors as to the choice of therapy.

Before granting permission for conducting a clinical trial in our country, the Ministry of Health submits them to the Office of Registration of Medicinal Products, Medical Devices and Biocidal Products, the Central Register of Clinical Trials (CEBK) that controls the compliance of audit documentation with legal standards.

After the consent for conducting the study has been granted, already during its duration the CEO of the said Office has the possibility of controlling the research by the help of the Clinical Trial Inspection; among other things, the application of the Good Clinical Practice standards, compliance of the test with the protocol, correctness of record keeping, etc.

Throughout the study, the Central Bioethics Committee also has insight into it, gathering information about side effects that occurred with its participants, analyzing any changes to the protocol and other documents determining the way the research, thus ensuring the safety of the participants.

The Bioethical Commission also supervises the course of the study at the level of the center, in this case it is its field department appropriate to the location of the center.

The representative of the Pharmaceutical Inspectorate has access to the treatment of medicines and medical substances.

The principle rule is a constant control of the way the research is carried out and the data are collected by the representative of the company organizing the so-called monitor. It is also possible for the sponsor to conduct special visits aimed at quality control.

The center can also be audited by representatives of various organizations: the research organization, the sponsor, the Clinical Trial Inspection, as well as the audits carried out by the FDA.

If necessary, the Ombudsman for Patients’ Rights will also have access to the conducted examination.

Legislation regarding Conducting of Clinical Trials

All legal regulations related to Clinical Research can be found at:

Baza wiedzy Stowarzyszenia GCPpl

The GCPpl Association we are a member of, constantly updates the information contained therein.

Compulsory Insurance
Polish law absolutely requires that every participant taking part in a clinical trial has to be insured against the negative effects of taking the test substance. This is included in the Ordinance of the Minister of Finance of 30 April 2004 on compulsory third party liability insurance for the researcher and the Sponsor, as amended.

Just as the drug manufacturer takes responsibility for any negative effects of its action not included in the "Summary of product characteristics" (see "WHAT IS A MEDICINE" tab), so the sponsor - the producer of the test substance is responsible for its action.

A prerequisite for registering the study in Poland (see the tabs 'STAGES OF CLINICAL STUDY' and 'INSTITUTIONS SUPERVISING CLINICAL STUDY') is the presentation in CEBK of the so-called "Sponsor and researcher policy", purchased at an insurance company by the sponsor, which strictly determines the number of insured participants in the study in Poland. This may be the reason for not being able to include another participant in the study.

A copy of this policy is located in each research center. Each participant of the study may become familiar with its content.

Optional Insurance
Every doctor, including of course a doctor conducting clinical trials, is obligatorily buying out a third party insurance policy covering any claims; the cost of treatment, the cost of compensation for patients who have suffered health damage as a result of their incorrect decisions. Because, according to Polish law, clinical trials are not a patient's treatment, because they use no medicine (see the "WHAT IS A MEDICINE" tab) and the test substance; this insurance is limited to a limited extent during the clinical trial.

Therefore, our center has a special third party policy, covering the same scope as policies regarding medical activity, but operating in the field of clinical trials.

Patients planning to participate in a clinical trial must meet certain requirements. The patient receives a print of the so-called “Information for the clinical trial participant and the informed consent form”, in order to get acquainted with the course and objectives of the study, the characteristics of the test substance and test procedures, and the requirements set for him.

It is absolutely necessary for the patient to agree to participate in the study before performing any of the test procedures. Only at this point he becomes a PARTICPIANT OF THE REASEARCH.

The basic requirement for a participant in a clinical trial is his consent to provide medical data for statistical analysis, these data are, of course, guarded – patient’s personal data is not shared.

In order for the data for statistical analysis to be repeatable, all participants must report for visits at equal intervals between visits, which determines the rigid – within a few days, dates of visits.

Each participant of the study is obliged to provide the investigator’s physician with complete and reliable data on his or her health status and medications, both before and during the study.