Romanian patients, caregivers, the medical community and the general public can access information about ongoing clinical trials in Romania through a new online platform, in Romanian, connected to the European Union database.
The National Agency for Medicines and Medical Devices in Romania (NAMMDR), together with the Health Innovation Hub, have developed and launched the online Platform for facilitating access to clinical trials in Romania, available at https://studiiclinice.anm.ro/.
“The online platform for facilitating access to clinical trials in Romania is the first major deliverable of this project, within the Health Innovation Hub, being both an informative and educational tool.
We thus support the development of a competitive model for clinical trials in Romania, providing patients with the opportunity to make informed decisions and access advanced therapeutic opportunities. Of course, the decision to enrol a patient in a study belongs exclusively to the patient and the treating physician, in compliance with the inclusion or exclusion criteria and the clinical evaluation of the patient.
We want this platform to strengthen the public’s trust and support the evolution of a predictable, efficient and people-oriented medical research framework” said Conf. farm. Răzvan Mihai Prisada, President of the NAMMDR and project coordinator.
Present at the event, Claudiu Damian, Secretary of State in the Ministry of Health, highlighted: “Today we emphasize an essential aspect for the future of the Romanian medicine: the development of high-level medical research, a field without which we cannot talk about real progress in patient care. The most concrete expression of this development is represented by clinical trials with medicines for human use, which bring direct and multiple benefits both to patients and to the entire health system. For patients, clinical trials mean access to the latest molecules, to innovative therapies, at the same time and under the same conditions as patients in any other European Union state. It is an opportunity for modern treatment, rigorous supervision and international standards of quality.”
This initiative is the result of an extensive collaboration between the Ministry of Health, the G6-UMF University Alliance, the Local American Working Group (LAWG), the Coalition of Chronic Disease Patients’ Organizations in Romania (COPAC), the Association of Patients with Autoimmune Diseases (APAA), the National Society of Medical Oncology in Romania (SNOMR), the Association of Clinical Trial Leading Companies in Romania (ACCSCR) and other interested entities. The project was implemented with the technical support provided by IQVIA Romania.
Present at the launch event, Prof. univ. dr. Alexandru Rafila, President of the Health and Family Committee of the Chamber of Deputies, said: “Teamwork and multi-sectoral collaboration made the difference in the case of the Innovation Hub. The approval of the National Strategy and the legislative changes have increased 3 times in the last year the number of clinical trials and implicitly the patients’ access to innovative medication! The launch of the Platform on the NAMMDR website significantly improves access and transparency for patients and doctors. Thank you to all those who contributed to this successful project carried out in the last 2 years!“
Prof. univ. dr. Carmen Orban, President the Senate’s Subcommittee on Population and Development, added: “The need for clinical trials is obvious. The platform is a valuable resource for patients, doctors and the medical community, providing real-time information, in Romanian, about available clinical trials, classified by therapeutic areas and geographical distribution. Quick access to such information can be crucial for patients, and feedback from both patients and doctors is essential for the continuous improvement of the platform.”
The platform is the resource that patients, patient associations, doctors, health units, as well as other interested parties can access to find out information, in Romanian, about the clinical trials available in Romania, classified by therapeutic areas and geographical distribution. The information is taken in real time from the database of the European Medicines Agency – CTIS. The platform also fulfills an educational objective, through which it provides clear and accessible information for patients, investigators and the general public on the conduct of clinical trials.
As a representative of the medical and pharmaceutical academic environment, Prof. univ. dr. Viorel Jinga, Rector of UMF Carol Davila in Bucharest, G6-UMF University Alliance, believes that “The transparency of clinical trials is essential for rebuilding public trust in research. Patients need to know what studies are being conducted in Romania, where they can participate, what are the benefits and risks, who coordinates them and what are the results. The correctly presented information generates confidence both in the medical system and in the country’s ability to be an international partner in the development of innovative therapies. At the same time, the platform will be a valuable tool for researchers and universities. For academia, this means quick access to real data, an indispensable resource for publishing scientific papers, supporting grants or initiating international consortia.”
Prof. univ. dr. Radu Iliescu, Vice-Rector of UMF “Grigore T. Popa” Iași, G6-UMF University Alliance, said at the event: “The platform is important because it makes visible something essential: the fact that clinical research is an integral part of what modern medical practice should mean. If we want Romanian medicine to truly be evidence-based medicine, then the Romanian clinician must not only be a consumer of scientific information, but also a generator of it. Evidence-based medicine is only sustainable in an environment where professionals understand the research methodology, participate in studies, lead projects and are able to critically evaluate new evidence.”
The representative of the innovative pharmaceutical industry, Frank Loeffler, President of the Local American Working Group Association (LAWG), highlighted that “This new national platform brings transparency to clinical research in Romania. It gives patients, physicians and research centres clear, real-time visibility of available studies and helps connect patients to innovative treatments in a simpler, more accessible way.
As we build on this foundation, the next key opportunity is to ensure a predictable reimbursement environment, so that all patients can access innovations in Romania as fast as in other European countries. Romania needs to claim its position as an international research hub in the development of innovative treatments and Romanian patients need to claim their right to access those innovations as fast as other European citizens.”
The project was developed as a result of proposals from patient organizations and professionals in the field, with the support and involvement of numerous partners of the Health Innovation Hub. The launch of this Platform represents an important step towards completing Romania’s digital healthcare infrastructure.
“The proposal for the development of this clinical trial platform came from patient organisations and I was enthusiastic to see with the openness I found from the Health Innovation Hub and in the partnership with the NAMMDR. Both patients and doctors can access the platform for information about clinical trials, as well as for searching for an ongoing study in Romania. The collaboration with the European Medicines Agency allows the platform to be updated daily, and the information area for patients will be expanded so that patients can find educational materials as applied as possible for their searches,” said Rozalina Lăpădatu, President of the Association of Patients with Autoimmune Diseases (APAA).
“The platform is one of the few initiatives in health that has brought together institutions, academia, industry and patient associations to contribute to its development, and this is just the beginning. In the next step, we see the need for communication campaigns on clinical trials at national level, an open dialogue with multiple organizations that can support patients in identifying studies, as well as the extension of the horizon of activities towards European approaches in the field of clinical trials,” said Luminița Vâlcea, Executive Director of the Coalition of Organizations of Patients with Chronic Diseases (COPAC).
Present at the meeting, Rialda Răduc, General Manager of the National Society of Medical Oncology of Romania (SNOMR) said: “The launch of this platform marks an important step for transparency and access to clinical trials in Romania. In order to catch up with advanced countries, the efforts of the Health Innovation Hub partners need to be complementary and convergent. SNOMR, through the projects submitted for European funding, has demonstrated clear directions of action: human resource training (training and mentoring programs for young oncologists, training and shadowing internships in accredited oncology centers), international promotion of the potential of Romanian centers and attracting sponsors. Through these steps, SNOMR aims to strengthen Romania’s credibility as a strategic partner in European clinical research.”
Clinical trials contribute to the creation of a modern, innovation-oriented healthcare system, generating a positive impact on patients’ health, providing them with a bridge to the latest medical technological innovations. Romania is one of the few countries in the European Union that have developed a Strategic Plan in the field of Clinical Trials, coordinated by the NAMMDR and carried out with the support of the Health Innovation Hub in 2024. The platform for facilitating access to clinical trials in Romania is a priority action in the strategic areas of intervention of the plan.
As President of the Association of Leading Clinical Trial Companies in Romania (ACCSCR), Dr. George Tănăseanu highlighted: “I am pleased to express our appreciation for the successful launch of the Online Platform for Facilitating Access to Clinical Trials in Romania, an initiative developed by the National Agency for Medicines and Medical Devices of Romania (ANMDMR) in collaboration with the founding members of the Health Innovation Hub – the Ministry of Health, the G6-UMF University Alliance, and the Local American Working Group Association (LAWG).
This platform represents a significant milestone for Romania’s clinical research ecosystem. By integrating real-time data from the European Medicines Agency’s CTIS database and providing accessible information in Romanian language, the platform empowers patients, healthcare professionals, investigators, and institutions with a clear, comprehensive overview of ongoing and upcoming clinical trials across therapeutic areas and geographic regions.
The Romanian CRO Association fully supports this initiative and remains committed to working alongside ANMDMR, the Ministry of Health, academic institutions, and all partners involved to further expand Romania’s capacity to attract and conduct high-quality clinical trials. Together, we can improve patient access to innovative therapies, increase research opportunities, and position Romania as a preferred destination for global clinical development programs.”
Dr. Teodor Blidaru, Manager of the Health Innovation Hub mentioned: “This platform becomes a facilitator of the clinical trial ecosystem in Romania, providing doctors and patients with real visibility on active studies at national level. Moreover, this platform represents a concrete deliverable of the Health Innovation Hub and proves that public-private partnerships can work when there is a common vision and a clear goal.”
Data from the European Clinical Trials Information System show that in December more than 720 studies are underway in 385 medical centers in Romania, out of a total of 10513 trials conducted in Europe. Romania occupies a middle position in the ranking of Central and Eastern European countries in terms of the number of studies carried out and has made notable progress in recent years in this important field.
