SAFETY OF CLINICAL TRIAL PARTICIPANTS
Our Activities
At our clinical research center, we assess the bioequivalence of medicinal products that a clinical trial sponsor (pharmaceutical company) intends to bring to market. Drugs that are reintroduced to the market are referred to as generic drugs. Generic drugs (generics) have the same composition and are analogs of already approved, used medications, but they are produced by a different company under a different name. The original medicinal product has already been thoroughly investigated pharmacologically, toxicologically, and clinically. The aim of our research is to ensure that the generic drug will have precisely the same pharmacokinetics as the original. This means that we analyze the rate and extent of absorption, distribution, and elimination of the drug from the bloodstream.
Regulatory Oversight
In most cases, regulatory authorities, such as the EMA (European Medicines Agency), require that bioequivalence studies (which are a key part of the generic drug approval process) be conducted with healthy volunteers. This requirement arises from the need to obtain objective data that is not distorted by external factors.
A clinical trial can only commence after receiving a positive opinion from the ethics committee and obtaining approval from the Ministry of Health, based on the evaluation of the project documentation and the medicinal product in the Central Register of Clinical Trials (CEBK), a unit operating within the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products. The principal investigator and the trial sponsor are obligated to continuously report any adverse events reported by patients to the ethics committee. The committee may decide to suspend the trial if experts deem that the risk-benefit ratio precludes further progression of the project. This provides additional protection for the rights of participants. The pharmaceutical company also regularly updates all doctors, CEBK, and ethics committees.
Medical Insurance
Each participant is covered by mandatory medical insurance funded by the trial sponsor. Participants have the right to review the insurance policy throughout the duration of the study.
Summary
Why healthy volunteers participate in clinical trials:
- Accuracy and Clarity of Results: In a healthy body, no other diseases or conditions can affect the action of the drug. This allows us to precisely examine how the drug is absorbed, distributed, and eliminated from the body.
- Rapid and Accurate Analysis: A homogeneous group of healthy volunteers enables us to smoothly and accurately obtain reliable and precise results.
- Participant Safety: Conducting studies with healthy individuals eliminates the risk of complications and side effects since healthy people do not take other medications and do not have conditions that could interact with the study drug and increase the risk of adverse reactions.
An additional benefit of participating in clinical trials, besides actively contributing to the development of modern treatment methods, is that each participant will receive financial compensation for their involvement in the research project. The average compensation amounts to 600-800 euros.
We invite healthy volunteers who want to make a real impact on the advancement of modern medicine!