Updates on the Current State of Clinical Research Development in Romania

The Round Table event, organized by the Association of Clinical Research Organizations of Romania (ACCSCR) in collaboration with the Avantyo Institute of Clinical Research, took place at the Athénée Palace Hotel, Le Diplomate Hall, on June 6th. The event focused on recent advancements in the clinical research industry in Romania. The aim was to foster meaningful discussions and collaborations among key stakeholders in the clinical research sector. Under the theme "An Overview of the Current Clinical Research Landscape in Romania," the event highlighted recent developments in our country's clinical research industry. We were delighted to bring together pharmaceutical companies and CROs, patient associations, representatives from the Ministry of Health, governmental agencies, local academia, and representatives from the European Federation of CROs (EUCROF) to share perspectives, explore opportunities for advancement, and implement lasting reforms.

The event consisted of two sessions: "Updates on the Current State of Clinical Research Development in Romania" and "National Strategy for the Development of Clinical Research in Romania."

Opening Remarks

Dr. Cristina Florescu Moraid, CEO of the Avantyo Institute of Clinical Research, kicked off the event, emphasizing its purpose.

“Thank you for being with us today. This Round Table is a great opportunity to discuss the current clinical trends in our country and their development. We have representatives from the National Agency for Medicines and Medical Devices of Romania, the Bioethics Commission for Medicines and Medical Devices, patient associations, and CROs. I would like to take this opportunity to have an interactive session to highlight the strengths and weaknesses of clinical trends in Romania.”

Session 1: Updates on the Current State of Clinical Research Development in Romania

Mrs. Diana Păun, Presidential Advisor at the Romanian Presidential Administration, expressed her honor in representing the presidential administration alongside distinguished experts and professionals in the clinical research field.

“Clinical research is a cornerstone of a modern healthcare system, bringing medical innovation closer to patients and doctors. Romania benefits from a favorable framework for clinical research development, with estimates suggesting that the Romanian clinical research market could triple from €72 million in 2019 to over €210 million by 2026. Conducting clinical trials also offers a tremendous opportunity for patients to access the latest treatments and specialized medical services that can significantly improve survival and quality of life.”

Mrs. Păun also underscored the crucial involvement of the academic environment in clinical research.

Dr. Martine Dehlinger Kremer, President of the European Federation of CROs (EUCROF), provided an overview of the clinical research landscape in the European Union and Romania.

“Globally, the USA leads in the number of drugs produced, followed by China, South Korea, the UK, Germany, Canada, Australia, and other countries. Romania contributes 5.1% to the global production of drugs and ranks among the top 27 countries worldwide. We cannot compare the USA with a single country; we must compare the USA with Europe. The USA has 11,000 drugs in development, while the EU has 28,000. I believe we are well-positioned.”

Dr. George Tănăseanu, President of the ACCSCR and General Director of PSI CRO AG, thanked all participants and highlighted the significant progress made in clinical research in recent years, emphasizing the essential contributions of those involved.

“The ultimate goal of our efforts is simple: improving the health and well-being of individuals and communities. Each clinical trial represents a beacon of hope for patients and their families. We have a collective responsibility to turn this hope into reality by promoting ethical and innovative research practices.”

The first session continued with open debates alongside representatives of national authorities and the Romanian academic environment. Mr. Răzvan Prisada, President of the National Agency for Medicines and Medical Devices of Romania (ANMDMR), provided updates and statistical data on the current trends in clinical research in Romania.

“Our main objective is to analyze Romanian patients’ access to medicines, especially new molecules. Access to medicines begins before authorization, and if we want to address this issue, we must start with clinical research. By unblocking this aspect, we can then address delays and problems in the authorization process, including HTA. Starting this year, we have focused on developing a new and thoroughly revised HTA methodology in Romania. If we manage to make significant changes, in a few years, I will return to demonstrate the results of our actions. If we apply in HTA what we have achieved in clinical research, we can ensure Romanian patients have access to innovations simultaneously with other EU citizens.”

Mrs. Prof. Dr. Doina Drăgănescu, President of the National Bioethics Committee, offered an update on the committee’s current activities and, as a representative of the academic environment, presented achievements in this field.

“Last year was full of administrative transformations. We are now part of the Academy of Medical Sciences and coordinated by it. In difficult times, you discover the friends who stand by you; we managed to continue our activity thanks to the tenacity of each specialist in our committee and the warm collaboration with the National Agency for Medicines, which provided practical legal solutions. We also highlighted the assistance and concrete intervention of ACCSCR representatives. We have used the dialogue between CROs and the national committee thanks to them. Considering the need for personnel training in this field, as Dean of the Faculty of Pharmacy at the University of Medicine, we initiated a master's program last October, involving professors from the faculty and companies that can sign agreements with us to provide practical internships for our master's students. In numbers, between 2020 and 2023, we issued over 6,500 documents after evaluating clinical trial dossiers. In conclusion, we have a good and safe environment for clinical research development in Romania.”

Mrs. Rozalina Lăpădatu, President of the Association of Patients with Autoimmune Diseases (APAA), presented the patient’s perspective on clinical research development and their needs.

“Collaboration with the Innovation Hub allows us to present patient needs regarding new therapy development and clinical trials in Romania. A coherent strategy for clinical research is essential and should be supported by educational campaigns for patients and doctors. The expression 'I don't want to be a guinea pig,' which I often hear, is due to a lack of information and medical education about clinical trials. Participation in a clinical trial does not mean being a Guinea pig. Therefore, we need to explain the benefits of participating in a clinical trial and have the courage to discuss potential risks. APAA has a long-standing collaboration with Avantyo through webinars for patients and journalists to provide accurate information about clinical trials. We will continue this collaboration and develop tools to bring more information to patients and those interested in clinical trials. Direct promotion of clinical trials to patients in Europe facilitates the provision of precise and relevant information. It is easier to discuss clinical trials with patients before they meet with doctors or investigators, ensuring they have all the necessary information and can ask the right questions. In the future, I will continue to ensure that patients make informed decisions without pressure from medical staff or investigators. It is essential to separate the clinical side from medical research and clinical trials while having medical teams collaborate to choose the best therapeutic interventions for the patient’s benefit. Modernizing legislation in line with other countries’ examples will improve this process.”

Mr. Stefan Busnatu, Vice-Rector of the Carol Davila University of Medicine and Pharmacy, Bucharest, highlighted the importance of educating patients, doctors, and journalists about clinical trials.

“In terms of education and innovation, it is crucial to start with activities that educate journalists about the utility of clinical trials for the population and the involved doctors to avoid misinterpretations. We discussed this in the Innovation Hub, and it is extremely important. Regarding prevention in all health fields, it is vital to convince patients they are essential partners in this process. We need not only journalists and medical professionals but also medical influencers to emphasize the benefits of participating in clinical trials. If we limit ourselves to only medical professionals, academia, and journalists without involving influencers, we will not succeed. Engaging civil society in educational activities aims to produce and transmit education to patients, bringing them closer to academia and medical education. It is crucial for patients to trust us, a factor I often encounter in preventive cardiology. Recently, at a national forum organized by COPAC, we discussed universities collaborating with specific associations to raise awareness in the educational and clinical research fields, which are extremely important for development and sustainability. At the University, we are working on a pilot project to monitor and develop real data on secondary prevention and cardiovascular diseases. This personal initiative is essential for the evolution of clinical research today. In conclusion, we must work on multiple levels: patient education, medical professional education, opening universities to support pilot projects and gaining their support, and stabilizing how we work as medical professionals in hospitals.”

Session 2: National Strategy for Clinical Trial Development in Romania

The second session commenced with Dr. Claudia Hesselmann, CEO of Arensia Exploratory Medicine GmbH, who spoke about Romania's position within the European Union, the EU's role in the global clinical research landscape, and what is needed to remain competitive.

“Today, my colleagues presented statistics and details about the status of clinical trials in Europe and Romania. I will try to provide a different perspective. We offer patients early access to innovative medications. I will present the situation from an entrepreneurial viewpoint, focusing on the patients who are at the heart of our activities. The patients we see daily in our clinics often come to us without hope. We have patients in oncology trials who had a life expectancy of six months, and now, six or eight years later, they are still alive thanks to clinical trials with innovative therapies. This is our motivation—to fight and bring such innovative therapies to Romania. The pharmaceutical industry faces enormous pressures to remain competitive. Companies are moving towards regions with reduced bureaucracy, quick clinical trial approvals, and solid clinical research infrastructure. Although anti-SARS-COV2 therapy trials were approved and initiated quickly during the pandemic, we are now seeing approval times of up to 120 days at the European Union level, even for critical cases such as oncology trials. We must strive to reduce these approval times because patients cannot wait months to start treatment. Moreover, costs are rising, and Romania is no longer a country with cheap labor but a hub with talent and potential for innovation. Medical personnel involved in clinical research need to be motivated and compensated at levels comparable to Western European countries. This reality must be communicated to our research partners.In conclusion, Romania and Europe must become more globally competitive. Investments in research infrastructure and reducing bureaucracy are essential to attract early-phase clinical trials. These not only benefit patients but also the entire medical system."

The second session continued with Mr. Frank Loeffler, Vice President of the Local American Working Group (LAWG), Member of the Strategic Council of the Health Innovation Hub, and General Manager of Roche Romania.

“The European meeting of the Federation of CRO Organizations (EUCROF) in Bucharest highlighted Romania's progress in clinical trials and the promotion of innovation value. Over the past two years, national regulatory authorities' efforts have led to a significant increase in the number of clinical trials in Romania and the number of patients benefiting from them. Simultaneously, the Health Innovation Hub is advancing with the creation of the first development strategy for Romania's clinical trials sector, under the strategic coordination of the National Agency for Medicines and with the participation of all entities involved in this field: the Ministry of Health, the University Alliance G6-UMF, the innovative pharmaceutical industry represented by LAWG, the CRO industry represented by ACCSCR, investigators, and patient associations. We firmly believe that the progress of this strategic sector will bring tangible and measurable benefits to patients and the healthcare system, while also contributing to the increase of Romania's economic competitiveness,” stated Frank Loeffler, Vice President of the Local American Working Group and Member of the Strategic Council of the Health Innovation Hub, during the EUCROF meeting in Romania.