The smell of the new is still palpable in the newly installed Special Unit for Biomedical Research and Education in Thessaloniki. On its fourth floor Papageorgiou Hospital, area 500 sq.m. hosts this innovative division that first nationwidewhich will conduct phase I clinical trials and bioequivalence studies.

Department Director, AUTH Distinguished Professor of Medicine, Asterios Karagiannisexplains that in the first case we are talking about clinical trials that are being conducted in healthy volunteers and control new drugs in terms of safety and the dosage at which they should be given, while the second case concerns studies that test whether common medicines they are just as active and safe as the originals, which received a marketing license from EOF.

“If the plant runs at full capacity, the profit will reach several million euros.”

“Until now, these were studies that were carried out abroad, in India, Jordanto him Canada but also Eastern European countries. Huge sums of money went abroad. Now this money will stay here,” emphasizes Mr. Karagiannis, explaining that there were several Greek companies specifically for generics, which were forced to pay hundreds of thousands of euros to the relevant units abroad. If the Thessaloniki block manages to carry out a number of studies and operate at full capacity 365 days a year, profit will reach several million eurossome of which will be reinvested in the AUTH Faculty of Medicine as well as the unit itself.

However, financial gain is only one side of the coin. Within the framework of the modern block, they will work young scientists many specialties, from doctors to molecular biologists and chemists, and many new ones will have the opportunity to be trained. The space has a state-of-the-art laboratory where laboratory tests will be carried out. Doctors will be trained there for two years clinical pharmacology while in addition to their participation in clinical research, they will also be involved in the diagnostic laboratory treatment of poisonings, as stated by Nikolaos RaikosProfessor of Forensic Medicine and Toxicology at AUTH and Head of the Unit’s Laboratory.

First investigations

The procedures for certification and commissioning of the unit were completed in accordance with the schedule. Within the next month, the division is already kicking off with a phase I clinical trial of a new drug from an Australian pharmaceutical company. According to Mr. Karagiannis, a protocol was submitted to the EOF and is now going through the national ethics committee. Starting a clinical trial takes a long time strict control by regulatory authorities and therefore enough time, ranging from four to six months, to get the green light, says the emeritus professor.

The division is also in the process of writing a protocol for another generic drug research Greek company, as well as a phase II teaching clinic in collaboration with a foreign university in one new RSV vaccine (in the case of vaccines, the division may also conduct phase II clinical trials).

We are looking for volunteers

The search for volunteers is an important issue for the newly created unit. The first ones had already passed through her doors when she was asked to complete a clinical study to become certified.

“Greece does not have a culture of volunteers to participate in clinical trials.”

At the first stage, the required number of volunteers will be small. “The first trials are safe and we won’t have any problems with them. However, to study a vaccine, we will need 200 people over 60 years of age.we are already setting up a team and a network that we will be contacting to find a group of people who will want to participate, ”says George Papazisis, Professor of Pharmacology and Clinical Research Supervisor. As he mentions to K, there is no culture of volunteers in Greece to participate in clinical trials. “This is a field that we are now organizing to highlight the possible benefits that can be obtained by someone who participates in such a process,” the professor notes, specifying that research protocols are very strict, that specific medical tests are carried out for those who can participate, while there are 18 more beds, one bed in the intensive care unit and medical staff ready at any time in case of side effects.

“I wasn’t scared for a second”

A volunteer who participated in the Certification Unit’s first clinical trial told K about his experience. “It was a bioequivalence study. The staff were very friendly and the process was very easy. They gave me a pill, and then I stayed surrounded by the unit, and during the day they took some measurements. In fact, the whole process was completed on the same day,” he said. His main motivation was, he said, the advancement of science. “And in medicine and oncology, we are seeing an active development of drugs and treatment options, so every effort is important to find a drug that helps treat patients.. This is a proposal to science so that more can develop, ”he explained. At no stage in this process, he stated, did he feel fear or hesitation. “Everyone who worked there put me at ease and I never once felt uncomfortable, although any issue I had initially was dealt with directly,” he said, adding that the fact that such a procedure is performed in a hospital, gives you a lot of confidence. The volunteer describes that the scientific staff assured him that everything that comes can be handledand at the beginning there was an extensive briefing on the study protocol and discussion between him and the doctors.

At the end of the month, the results of the big researchwhich is part of the program speed upwhich will highlight the attitude of the Greeks towards their participation in the clinical trials of the vaccine, in order to clarify what the motivations will be and what are the obstacles to becoming volunteers.