What is a clinical trial?
Clinical trials are research studies, in which a reference medicinal product (original), that exists on the market and a generic medicine, which contains the same active ingredient, in the same quantity, is administered to healthy subjects, in order to compare concentrations in biological matrices(blood, urine, saliva, etc.)
All procedures are performed related to a clinical trial according to the protocol approved by the National Agency for Medicines, Medical Devices and the National Commission for Bioethics Medicines and Medical Devices.
The stages of a clinical trial are:
- The authorization of the clinical trials by the competent authorities;
- The study itself- including subjects, dosing, sampling biological monitoring;
- The follow-up(the final examination);
- Depending on the type of study (total period, molecule-type) the deployment can last 4-6weeks, the subject is hospitalized in our unit clinic around 36-72 hours in each period.
In functie de tipul studiului (numar perioade, tip molecula) durata de desfasurare este de 4-6 saptamani, din care subiectul este internat in unitatea noastra clinica in jur de 36-72 de ore in fiecare perioada.
How can you participate in a clinical trial?
In the trials without a therapeutic advantage only the subjects who express their personal approval are enrolled (in an approval paper, expressed learnedly, approved by the Ethical Committee and NAMMD before it is presented to the subjects).
In order to participate in a clinical trial, the subject has to comply with:
- The necessary conditions for a good development of the drug administration stage
- The diet prepared by the trial team
- The sampling program of biological samples
- The restrictions imposed via the approved clinical trial protocol (for instance: simultaneous medication, physical activity, diet)
The participant in a clinical trial has the following rights:
- The confidentiality of the personal data
- The detailed information, in non-technical terms, about the procedures of the clinical trial, the testing drug, the risks and the advantages of the participation.
- The necessary thinking time before the approval paper expressed learnedly is signed.
- The withdrawal of the trial at any time, without being forced to communicate the reason of its decision and without being caused any prejudice as a consequence of his withdrawal.
Why to participate in a clinical trial?
- Beneficiati de o examinare fizică completă, analize medicale (inclusiv pentru HIV și Hepatită B, C) și examinări paraclinice (dacă este cazul) – gratuit
- You benefit from a complete physical examination, medical analyses (inclusively for HIV and Hepatitis B, C) and para clinical examinations (if it is the case) – for free
- Accommodation facilities and free meals, TV access, internet and medical assistance are assured
- Medical assurance is completed for possible prejudices regarding the medication administration of the clinical trial
- You are paid according to the period of the participation and the complexity of the clinical trial
- You benefit from a complete medical final exam
What are the risks of the participation in a clinical trial?
The risks of the participation in such a trial are minimal due to the fact that:
- It is generally administrated on health subjects only one dose/period
- The testing drugs are well known and used in the current medical practice
The known side effects of the testing drugs are brought to the attention of the subjects before their enrollment in the clinical trial. The active substance, responsible for the therapeutic effect of a drug, is not an unknown/new component. This one is part of the composition either of the drug of reference, but also of the test and the therapeutic effects, as well as the side ones are known to it from the medical practice of approximately 10 years.
How can you contact us?
Dr. Elena Timofte, , Head of The Clinical Unit: 0751 020 916 or la 0740 235 129