Clinical Trials

Clinical trials involve research into medicines and medical devices in volunteers with the aim of providing potentially more effective treatment. The outcome of a clinical trial of a medicinal product is the development of a safe and effective medicine that brings innovative treatment approaches. Clinical trials follow extensive preclinical testing. They consist of four phases, each of which must meet specified criteria regarding patient selection, the number of participants, and specific objectives. The conduct of clinical trials is subject to a strict approval process, the primary purpose of which is to ensure the protection and rights of patients. The conduct of a clinical trial itself is also a very time-consuming, strictly controlled, and monitored process.

For Patients

Participation in a clinical trial is voluntary and must be documented by the patient’s signed informed consent. Before entering the study, the patient must therefore be informed about all potential risks arising from this step. A clinical trial participant has the right to ask about anything they are interested in regarding participation in the clinical trial, and may withdraw their consent at any time.

Frequently asked questions from patients:

What do I gain by participating in a clinical trial?
A well-designed and approved clinical trial is the basis for an eligible patient to actively influence their healthcare. In this way, you may, for example, gain access to treatment that is not yet available to the general public. You will also receive significantly more healthcare, because patients enrolled in a clinical trial benefit from increased attention from the physician and their team. The main reason for the increased attention is that the trial sponsor needs to obtain as much information as possible, particularly given the previously insufficient amount of data on all effects of the medicine. Treatment, procedures, and examinations are covered by the trial sponsor. Your participation will help contribute to medical research in that information from the clinical trial can help physicians and the professional team gain further knowledge about medicines, health conditions, or disease.
How can you guarantee that I will not become a so-called guinea pig when I sign the informed consent?
Under the Medicinal Products Act, a clinical trial must be approved by ŠÚKL, and from an ethical perspective it must be assessed by an ethics committee. The approval process must comply with Act No. 362/2011 Coll. on medicinal products, which guarantees that no experiments will be performed on you that you have not been informed about or do not consent to. A clinical trial must be conducted in accordance with the ethical principles defined in the Declaration of Helsinki (Question No. 21: What is the Declaration of Helsinki?) and in accordance with the principles of Good Clinical Practice (Question No. 20: What is Good Clinical Practice?).

What happens if my trial is terminated early?
If the trial is terminated early, the patient must be informed immediately of the reason for terminating the trial. The physician also understands that standard healthcare must continue to be ensured for you.

What is a placebo?
A placebo looks just like the investigational medicine, but it does not contain any active substance. In certain cases, placebos are used in clinical trials to compare the investigational treatment with a placebo. The placebo effect can be real and can indeed lead to an improvement in a patient’s health if the patient believes the treatment will improve their health. To eliminate this issue, treatment assignment in clinical trials is blinded (i.e., clinical trial participants do not know what treatment they have been assigned—whether they are receiving the investigational medicine or a placebo). Blinding ensures that the changes recorded in patients are not random and that their assessment is objective.

Are there any risks associated with participating in clinical trials?
Participation in clinical trials may involve certain risks. Most clinical trials carry risks of mild discomfort that lasts a short time, although some participants may experience more serious complications requiring medical care. The specific risks associated with a clinical trial are always described in the document referred to as informed consent, by signing which clinical trial participants voluntarily agree to participate in the clinical trial. Serious risks are also explained to participants by the trial physicians, who also answer all questions regarding the clinical trial. Before deciding to participate in a clinical trial, potential risks are assessed very thoroughly.

EVERYTHING A PATIENT SHOULD KNOW ABOUT CLINICAL TRIALS CAN BE FOUND IN THE BROCHURE.

Clinical trials at the Faculty Hospital Nitra focus mainly on innovative treatment of neurological diseases, oncology, internal medicine, infectology, skin diseases, and others.

Administrative support and coordination of clinical trials at FN NR is managed by the Department of Clinical Pharmacology.

For Sponsors

To simplify cooperation, please read the recommendations below:

1. Draft contract

At FN NR, the contract is concluded as a tripartite agreement between the sponsor, the healthcare facility, and the principal investigator.
If the contract is bilingual, in the event of any discrepancy between the Slovak and English language versions of the contract, its annexes, or any amendments, the Slovak version shall prevail.
If the sponsor lends equipment or other technical devices for the purposes of the clinical trial, a separate contract is not required; instead, a loan agreement may be included as an annex to the main contract.
Contract negotiation is ensured by:

from a legal perspective, the Department of Legal Services
from a financial perspective, the Biomedical Research Unit, the Clinical Trials Unit (in cooperation with the principal investigator), and the Deputy Director for Economics and Operations of FN Nitra (final approval).
You may send the draft contract with the budget to patricia.hudecova@fnnitra.sk

2. Laboratory testing

The hospital performs basic and specialised haematological and haemocoagulation tests.

3. Ethics committee

A clinical trial is assessed by an ethics committee, which meets regularly every 4 to 6 weeks.
When submitting an application to the ethics committee, the required documents must be provided at least 10 days before the ethics committee meeting.
If you have any questions, please contact patricia.hudecova@fnnitra.sk – tel. no.: 037/6545 520

4. Budget

The contract includes a budget and its allocation between the healthcare centre and the trial team. Remuneration for the trial team is best handled via a separate contract between the sponsor and the trial team, with payments transferred directly to their personal accounts without the hospital’s involvement.

5. Therapeutic areas of clinical trials

At FN NR, clinical trials are conducted in oncology, neurology, surgery, internal medicine, gastroenterology, and dermatology, and we also plan to conduct clinical trials in other specialties.

List of physicians interested in participating in clinical studies