New challenge for the Clinical Trials Department - COVID-19 vaccination study
3. 9. 2020 |
Ing. Lucie Tesárková is the interim head of the Clinical Trials Department of the International Clinical Research Center of St. Anne's University Hospital Brno (FNUSA-ICRC). On this occasion, we asked her for a short interview, where she would present the activities of the department and describe plans for the future.
How would you describe the activities of the FNUSA-ICRC Clinical Trials Department to the general public?
We can simply say that our department is in charge of everything related to the preparation and implementation of clinical studies at the St. Anne's University Hospital Brno (FNUSA), from the solution of clinical study offers to their archiving. We have employees who are responsible for the process of negotiating and concluding contracts for clinical trials of all phases carried out at FNUSA, as well as employees who take care of the financial management of clinical trials. Another integral activity that we provide is the support of physicians and other medical staff during the implementation of the study through study coordinators. An equally important area we deal with is the administrative support of physicians in the field of academic clinical research carried out at FNUSA.
How is the cooperation with the hospital set up?
Due to the fact that we process clinical studies within the entire teaching hospital, we work very closely with the legal department, finance department and other professional workplaces that are involved in conducting clinical studies.
In which areas are clinical trials conducted the most?
We can say that the studies take place in basically every clinic in FNUSA. These are mainly clinical studies in the field of neurology, cardiology, gastroenterology, dermatology, rheumatology and oncology.
How will patients find out about ongoing studies at FNUSA and how can they possibly sign up?
A list of clinical trials in which patients are being recruited is published on the FNUSA website in the Clinical Studies Department section. We update this report regularly. For each study, there is a contact person to whom the patient can contact if they are interested in more information about the study. We are currently working to support patient recruitment in clinical trials for patients with Crohn's disease, ulcerative colitis or rheumatoid arthritis.
How did the epidemiological situation in connection with COVID-19 affect the activities of the Department of Clinical Studies?
At the beginning of the pandemic, the situation was very confusing for us and it was difficult to predict its further course. Despite all the circumstances that the unfavorable epidemiological situation brought, it was a priority for us to provide care for patients enrolled in clinical trials so that their treatment could continue smoothly. My colleagues and I worked out several variants of plans for different degrees of severity of the epidemiological situation so that the relatively smooth running of the studies could be maintained for each of them. Of course, we also had to reckon with the worst option, ie a situation where our hospital would close and serve only patients with COVID disease. Fortunately, this did not happen, and I think I can say that in cooperation with doctors and other health professionals, we managed the situation very well.
Is FNUSA involved in the implementation of COVID-19 clinical trials?
Yes, FNUSA is also being approached with offers to conduct studies focusing on COVID-19. These are studies evaluating the safety and efficacy of medicines for patients with COVID-19 disease of varying severity, but also offers for vaccination studies performed in healthy volunteers. Vaccination studies are a new area for us that we are now working on. We are currently preparing for the implementation of the first large vaccination studies with the participation of healthy volunteers. We are very pleased to have been approached with an offer, as FNUSA's medical staff are able to provide high-quality studies that can lead to the development of an effective vaccine.