Questions and answers regarding clinical trials

What are clinical trials?

Clinical trials are detailed medical programmes which aim at assessing the active substance- confirming its’ effectiveness and safety as well as showing its advantage over standard drugs. The conduct of such research is confirmed and monitored by proper governmental organizations i.e. Ministry of Health, The Bioethic Committee.

What active substances are subjected to clinical trials?

Clinical trials focus on entirely new substances, however medicines already available on the market may also be subjected to trials but being used in other diseases so far. These substances frequently prove to be a breakthrough in incurable diseases.

What are the advantages of volunteering in clinical trials?

  • Access to new, innovative treatment methods.
  • The data collected during clinical trials may contribute to expanding medical knowledge on the given disease and the methods how to cure it- patients participating in the clinical trials may contribute to successful entry of a new, effective medicine on the market and help not only themselves but also other sick people!
  • Each patient is under permanent control of a doctor who has access to advanced diagnostic methods which are not used in standard health care.
  • Transport to the clinical trial centre is provided as well as transport refunds.
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Can everyone take part in the clinical trial?

Due to safety procedures not everyone can take part. Before any patient is accepted to the programme, s/he has to undergo detailed examinations in order to exclude any contraindications.

How does the beginning of the clinical trial look like?

It is necessary to come to the facility which conducts the trials. Next, after an initial interview, the doctor will assess if in the given case there is a chance for participation in the clinical trials. Then, the rules along with the benefits and risks are thoroughly described by the specialist.  In order to take part in the clinical trial, the key principle is to provide informed consent. After the interview with the doctor , each patient receives an information form and informed consent form which contains a detailed description of the trial, information about the tested drug and all the procedures followed during the trial. In addition, prior to signing the consent, the patient is entitled to repeat a consultation with a doctor and ask questions while the doctor conducting a given examination is obliged to explain and provide all the answers. Participation in the clinical trials is voluntary and every patient has the right to withdraw his consent at any time without any consequences.

What are the STAGES of the medicine examination?

The medicine examination is conducted in four stages. Each has to finish with positive effect in order to proceed to the next stage.

  • Phase I aims at assessing the safety of the examined medicine. We test such factors as: absorption, metabolism, excretion, toxicity, interaction with food and commonly administered drugs. The result of this part of drug analysis allow us to specify the dosage. Phase I of clinical trials usually involves more than ten healthy volunteers. The Phase I research is conducted in especially accustomed clinical trials facilities belonging to pharmaceutical companies or research institutions.
  • Phase II aims at finding if the new drug works in the given group of sick and if it is safe. In this phase of the clinical trial, the new drug’s work is compared with a placebo or the work of the standard drug which is used in therapy of the given disease. This phase also helps to find correlation between the dose of the drug and its’ effect. It gives an opportunity to determine the dose which will be administered in the further phases of the research. In order to objectify the trials, the double blind test is applied (neither the patient or the researcher know what substance is patient administered). The trials in phase II are conducted in a group of a few hundred volunteers- patients suffering from the given disease. If the data analysis shows benefits for the patients with relatively little risk, the drug goes to the next phase.
  • Phase III of the trial is conducted in a group of a few thousand of patients  and its objective is to finally confirm the effectiveness of the given medicine. The safety of the medicine and its effectiveness regarding the time of use are evaluated. If this phase finishes positively and confirms previously obtained results, the manufacturer of the given medicine may commence the registration and sale procedures.
  • Phase IV of clinical trials refers to the drugs already being registered and available on the market. This phase makes it possible to confirm previously obtained results, assesses safety and directions of the drug to be taken.

Who SUPERVISES clinical trials?

Conducting clinical trials is approved and monitored by proper governmental organizations in the given country. In Poland  the Central Register of Clinical Trials (Centralna Ewidencja Badań Klinicznych, CEBK) constitutes department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products which deals with formal and material evaluation of the reported clinical trials. In order to commence a clinical trial in Poland, the  trials have to be reported to CEBK and receive consent of Polish Ministry of Health after having the conditions of the trial conduct confirmed by proper Bioethic Committees.

What are the RULES of conducting the clinical trials?

In order to provide proper conduct of clinical trials and security over volunteers, the clinical trial centre has to be obliged to follow particular rules i.e. Good Clinical Practice- GCP. Good Clinical Practice– constitutes the set of rules defining and determining the manner of planning, leading, monitoring, documenting and reporting the results of clinical trials which involve people and animals.

In our Clinical Trials Centre we strictly follow the patients’ rights, we work in accordance with the Polish Charter of Patients’ Rights and respect patients autonomy in deciding about participation and resigning of clinical trials.

THE POLISH CHARTER OF PATIENTS’ RIGHTS is a set of basic legal regulations collected in one document prepared by the Ministry of Health in 1998. This official document form was published as  a public announcement. Some of the provisions were updated. It is the first attempt of preparing a complex work in the area of Patients’ Rights in Poland.

For more detailed information check the following portals:

http://www.gcppl.org.pl/

http://www.urpl.gov.pl/

http://www.mz.gov.pl/

What are possible THREATS for the patient?

Administering any kind of drug carries a risk of side effects. During the visit in EuroMedis Clincal Trials Centre, the leading doctor will thoroughly explain the threats connected with the examined medicine and in particular the side effects if they are known. The patient receives information about the drug to read at home. After being acquainted with the details about the drug and clinical trial s/he provides an informed consent regarding participation in the clinical trial or resignation.

EuroMedis Clinicial Trials Centre

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