The conference “Clinical Trials in Romania – Education and Competitiveness”, developed through a partnership between the Academy of Medical Sciences (ASM) and the Health Innovation Hub, held at the Parliament of Romania, marked multiple achievements in the field of clinical research in Romania.
The event took place on the occasion of the 90th anniversary of the Academy of Medical Sciences, dedicated to the field of medical and pharmaceutical scientific research in Romania. The conference also marked two years since the establishment of the Health Innovation Hub, a platform that initiated the effort dedicated to the modern development of the field of clinical trials in Romania. The event was attended by numerous representatives of health authorities, the medical scientific community, the medical and pharmaceutical academic community, patient organizations, the innovative pharmaceutical industry, and the clinical trial coordinating industry in Romania.
“We are already seeing a significant increase in the number of clinical trials conducted in Romania, as well as in the number of patients who directly benefit from them – more than double compared to 2022. This evolution shows not only the potential, but also the possible impact of this sector on the healthcare system, on medical staff, and on the economy. At the same time, the quality of conducting these studies must remain a priority, beyond the numbers. I commend the efforts of the Health Innovation Hub and the involvement of all partners – it is an example of good practice in terms of interinstitutional and strategic collaboration,” stated Prof. Univ. Dr. Alexandru Rafila, Minister of Health, during the event.
In addition, the event is part of global actions meant to celebrate International Clinical Trials Day on May 20, recognizing the efforts of the many people who make clinical research and the improvement of treatments and medical devices possible. Clinical trials represent an essential part of the lengthy process of drug development, serving as a means to generate evidence regarding the effectiveness of medicines in treating certain conditions and to support regulatory decision-making for safe and effective new drugs.
“Clinical research is competitive, but ultimately for the benefit of the patient, who in this way has the possibility to be in direct contact with cutting-edge therapies and, implicitly, to gain access to revolutionary active substances in the medical field. The specialists needed in clinical research teams require continuous training on the one hand, which is why the presence of university representatives at these debates is essential, as they can provide concrete support through the educational programs they propose. Brought together, these two elements can ensure steady progress in the development of clinical trials in our country,” mentioned Prof. Dr. Doina Drăgănescu, President of the National Bioethics Commission within the Academy of Medical Sciences, Dean of the Faculty of Pharmacy, UMFCD Bucharest.
Romania’s progress in this important field is highlighted by Pharm. Dr. Răzvan Prisada, President of the National Agency for Medicines and Medical Devices of Romania (ANMDMR):
“ANMDMR actively and consistently supports clinical research in Romania through a regulatory framework that is predictable, transparent, and aligned with European standards. We are a trusted partner for all those involved in clinical trials – from researchers, to sponsors, to the patients who choose to contribute, through their participation, to the advancement of medical science.”
“I commend this initiative and the effort to bring together the main actors of the healthcare system in a constructive dialogue about the future of clinical research in Romania. It is our shared responsibility to encourage excellence, to support ethics and quality, and to strengthen our country’s position as a regional hub for clinical trials.””
Romania is the only country in the European Union with a Strategic Plan committed to attracting clinical trials, available on the ANMDMR website. In addition, Romania has outstanding potential in conducting clinical research, with the academic community playing an important role..
Prof. Univ. Dr. Ionuț Gheonea, Rector of UMF Craiova and President of the G6-UMF University Alliance, stated during the event: “The topic of my address is one of major importance: the role of universities of medicine and pharmacy in the development of clinical research in Romania, within a dynamic, competitive, and highly technologized European context. Romania benefits from remarkable human capital, a network of clinical hospitals, epidemiologically well-characterized patients, and, above all, an academic body that is engaged and eager to contribute to scientific progress.”
The universities of medicine and pharmacy are the living infrastructure of biomedical research. They train the human resource, develop laboratories and centers of excellence, uphold research ethics and integrity, and build bridges between the clinic and the laboratory.
The G6-UMF Alliance – Cluj, Bucharest, Iași, Târgu Mureș, Craiova, and Timișoara – promotes a common vision: a competitive medical Romania, anchored in European research networks and capable of generating clinical innovation with international impact.
In this regard, the G6 Alliance – together with the Ministry of Health and the LAWG Association – has initiated the creation of a National Innovation Hub in Medicine and Pharmacy, a collaborative structure designed to connect medical universities, clinical hospitals, partners from the pharmaceutical industry, authorities, and, not least, patients. Through this Hub, we aim to facilitate access to clinical trials, encourage translational research, and accelerate the digitalization of research processes.
The future does not belong to those who fear change, but to those who shape it. Let us, therefore, be that generation of universities that not only follows trends, but creates them./p>
Data from the European Clinical Trials Information System (CTIS) shows that in May, 548 studies were underway in 337 medical centers across Romania, out of a total of 9,143 trials conducted in Europe. Romania holds a middle position among Central and Eastern European countries in terms of the number of trials conducted and has recorded notable progress in recent years in this important field.
“Recognizing the importance of clinical research and the benefits of developing this sector, the partners brought together within the Health Innovation Hub have contributed to putting Romania back on the map of clinical innovation through numerous actions carried out over the past two years. These include the Strategic Plan coordinated by ANMDMR and developed with the involvement of more than 50 active representatives on this topic, communication and education activities in this field, as well as efforts already underway to develop a national platform where patients can identify ongoing clinical trials in Romania.
The growth of Romania’s competitiveness in the field of clinical trials depends on numerous factors; therefore, it is essential for key players to remain constantly involved, while the support of the authorities in coordinating this strategic direction must continue, thus contributing to the success of a sector with medical, scientific, and economic impact,” stated Iulia Arif-Percă, Executive Director of the Local American Working Group (LAWG), an organization serving as a founding member of the Health Innovation Hub, with 15 years of activity in Romania.
The Health Innovation Hub supports the actions proposed through the “Strategic Plan for Clinical Trials in Romania”, which targets five areas of intervention: raising awareness and promoting education on clinical trials, encouraging the development of human resources and trial centers, the process of mobilizing and selecting patients, promoting Romania’s potential internationally in conducting trials, and ensuring a competitive economic and fiscal environment to stimulate investment in clinical research in Romania.
