Simplifying and streamlining administrative tasks of clinical trials, increasing capacities, developing digital solutions and strengthening cooperation with industry partners are among the goals of Dr. János Filakovszky, Director of the Clinical Research Coordinating Center (4K). One of the center’s important responsibilities is to provide professional support to physicians, organizational units involved in clinical trials at the university.
Dr. János Filakovszky started his career as a neurologist: after his specialist examination he acquired a PhD degree as well, conducting research at the National Institute of Psychiatry and Neurology focusing on sleeping and epilepsy. He has been working full-time in the field of pharmaceutical developments for more than 20 years. He spent the longest time at Quintiles, a pharmaceutical research organization. He was the regional director of the company in Hungary when Semmelweis University became a priority clinical trial site of the American enterprise. Later, he became regional director in Vienna, and was responsible for the European and the African regions. He was also the global head of drug development for the central nervous system. He returned to Hungary from Sweden, where he was head of a clinical trial management company.
“One of the most important experiences that I have gained at the international market is that drug development and clinical trials initiated by the pharmaceutical industry are extremely complex, multi-stakeholder fields, where effective organization requires special professional experience”, Dr. János Filakovszky emphasized.
As he pointed out, there is no drug development without clinical trials, however the procedures and professional protocols have recently become more complex and quality criteria have also increased. Therefore, clinical trials can no longer be conducted without specialized and experienced teams.
Semmelweis University recognized the importance of this when the Clinical Research Coordinating Center (4K) was established as a support unit at the beginning of 2021. Also, the common interests of all participants related to the long and expensive drug developments are to increase efficiency, to simplify and accelerate procedures, which is supported by the development of technology as well.
The Clinical Research Coordinating Center (4K) set up in January 2021 is part of the recently established new R&D&I system. Its main objective is to make the operation of clinical trials and related administrative procedures more efficient and streamlined at the university.
Our aim is to reduce the process of signing contracts to 20 days. The aim is to have the institutional documents ready by the day official authorization is released. This will enable the university to be competitive in this field”
– the Director highlighted. To achieve this, simplifying administration related to both legal and financial-economic procedures is necessary. They also plan to increase the efficiency of patient involvement in clinical trials, which requires that both patients and physicians are aware of the different clinical trials available at the university. A long-term goal is to create an automated system that ensures the recruitment of patients. In addition, it is also important to have a list about the current clinical trials available at the university for the interested patients and physicians.
Dr. János Filakovszky emphasized the importance of increasing capacities. There is an ongoing survey assessing those therapeutic areas of the university, where even though the professional conditions are provided, yet there are no clinical trials. They will also examine potential opportunities for performance enhancement.
“Globally, the greatest demand for new developments is in oncology, immunology, cardiovascular diseases and gastroenterology, as well as dermatology. These account for about 65% of new drug trials, while the rest focus on neurological diseases affecting the aging population. A way to increase performance is to launch related training at the university for young physicians-investigators, coordinators and nurses participating in the study”, said Dr. János Filakovszky.
The Director is also associate professor at the Institute of Digital Health Sciences of the Faculty of Health and Public Administration as well as the course lead of the Slovakian-language program of the Health Services Management Training Center. He considers it essential to use new technologies, such as digitization (for example electronic signatures, online patient consent, remote health care applications and data monitoring, telemedicine) and to set up a quality assurance system for clinical trials. These make the institution even more attractive to industrial partners. At the same time, the university aims to have many more effective cooperation agreements with industrial players, like the recent agreement with Pfizer in addition to the existing key partnership agreements (IQVIA, Parexel, Abbvie).
“We plan to review existing contracts and sign new ones, making the administrative tasks involved in starting new clinical trials more efficient. It is also important to join as many international therapeutic research networks as possible. Such collaborations not only help increase the number of trials, but also enhance predictability and investigator-initiated clinical trials”, Dr. János Filakovszky highlighted.
He also pointed out that professional standards, instrumentation and experience are what attract drug development companies to the university.
“The more industry partners we work with in this area, the better we can increase the number of clinical trials on campus, which can boost scientific performance and help advancement in international rankings. It also allows Semmelweis patients to have access to the latest therapeutic opportunities and our physicians to gain first-hand experience of these”, the Director said.
Photo: Attila Kovács – Semmelweis University
Translation: Katalin Illés-Romhányi