MKVT

Usually, patients are informed about clinical research studies by their treating physician. If the treating physician is also involved in the research study, they can consult the authority-approved study protocol to decide whether a particular patient is eligible for participation or not.

If the treating physician is not involved in the research study, they can refer the patient to a study site and a study doctor who does participate in the trial.

Should the patient become aware of a clinical trial they are interested in and matching their condition, it is recommended to discuss the available study information with their treating physician or general practitioner. This might be useful as it allows a doctor who knows the patient well to assess whether the study is indeed suitable for the patient’s disease and condition, and they might help the patient in contacting the study site. After assessing the received information, the patient can decide whether they wish to reach out, with or without the treating physician’s assistance, to the center participating in the specific study.

Healthcare institutions participating in the trial might be inpatient clinics, specialist care sites, private healthcare or general practitioner offices or site management organizations (SMOs, mostly outpatient centers specialized in clinical research) previously selected by the study sponsor and approved by the authority to perform the study. In these study centers, the staff designated for the specific trial (study doctor, nurse, coordinator) look after the participants. One can not participate in a study at another care site or with another staff which have not been approved in advance.

If the patient is a minor or is legally incapacitated entirely or partly, their legal guardian and, according to their age/condition, the patient might request consideration of the possibility of inclusion to the study.

Several platforms offer information on clinical trials to the patients and their relatives. Nowadays we can come across clinical study information leaflets more and more often via brochures distributed in involved health institution, on the websites of the care site or at patient advocates. Sometimes, health institutions involved in research have a separate page on their websites, listing studies initiated by themselves or a pharmaceutical company.

These publications provide authentic information on the study, present by and large what kinds of patients are sought, furthermore provide the reader where to obtain more detailed information on the trial.

There are international and Hungarian registries of research studies. The Hungarian registry can be downloaded from the website of the National Institute of Pharmacy and Nutrition, which is the Hungarian competent authority (www.ogyei.gov.hu/egyeb_nyilvantartasok_listak/). International registries (www.clinicaltrialsregister.eu and www.clinicaltrials.gov) allow the visitors to browse ongoing or planned studies in Europe (or also other parts of the word) in English. However, this requires a bit of expertise and some command of the English language. For assistance, NIPN’s website offers a guidance on how the EU study website should be used.

However, these registries do not show which sites are participating in each study, and as such, they are of limited usefulness for the patients.

As a non-governmental organization made up of several stakeholders involved in clinical studies, the Clinical Trial Management Society, Hungary also wishes to contribute to the appropriate conduct of trials by promoting patient information. For this purpose, we have created the Clinical Trials (“Klinikai Vizsgálatok”) website (klivi.hu), which offers useful information for interested visitors about clinical studies in general, and also answers a number of practical questions.