What is a clinical trial?
A clinical trial is a research program with the participation of patients (study participants), which verifies the safety of use and efficacy of a given medicinal substance/medical device.
Every new substance or technology first undergoes very detailed and rigorous testing before it is registered and marketed.
Therefore, patients who take part in a clinical trial are under constant scrutiny by medical personnel to report on their health status.
Any deviations from the norm that occur are therefore also included in the medical records of the trial participant.
Based on the analysis of the results obtained during the clinical trial, it is therefore possible to conclude whether a product meets safety and efficacy requirements, which then provides the basis for marketing it.
Who can participate in a clinical trial?
Information on who can participate in the study is contained in the clinical trial protocol.
It specifies the so-called.
inclusion criteria and exclusion criteria.
A doctor, who is referred to in clinical trial nomenclature as an investigator, decides whether a person is eligible for a particular trial and thus can participate in it.
He or she is also required to inform any willing person of the potential benefits and risks of a particular study, as well as answer any questions the patient may have.
What are the responsibilities of the patient participating in the study?
The patient’s signing of the informed consent to participate in the study obliges him or her to follow the guidelines specific to the particular clinical trial.
Depending on the particular study, the responsibilities placed on patients can vary.
The most common tasks of a participant include.
taking the drug as prescribed, making follow-up visits, reporting the presence of worrisome symptoms, keeping a diary to monitor certain parameters, completing health questionnaires, etc.
However, at any time during the clinical trial, it is possible for the participant to withdraw from further participation.
Our mission
Using our experience and the potential of a specialized treatment entity such as the MEDINCUS Hearing and Speech Center, we want to actively participate in the development of medicine and thus raise the standards of treatment.
This is possible because of the chance to improve the health of patients participating in individual trials and, consequently, the entire population struggling with the disease.