Information on ongoing clinical trials in Romania can now be accessed through a new online platform in Romanian, linked to the European Union database, the National Agency for Medicines and Medical Devices of Romania (ANMDMR) announced.
According to a press release sent to AGERPRES on Friday, the Health Innovation Hub and ANMDMR have developed and launched the online platform to facilitate access to clinical trials in Romania, available at https://studiiclinice.anm.ro.
Implemented with technical support from IQVIA Romania, the project is the result of collaboration between the Ministry of Health, the G6 University Alliance (UMF), the Local American Working Group (LAWG), the Coalition of Patient Organisations with Chronic Conditions in Romania (COPAC), the Association of Patients with Autoimmune Diseases (APAA), the National Society of Medical Oncology in Romania (SNOMR), the Association of Companies Conducting Clinical Trials in Romania (ACCSCR), and other interested entities.
Data from the European Clinical Trials Information System shows that in December, over 720 studies are underway in 385 medical centres across Romania, out of a total of 10,513 trials conducted in Europe. Romania ranks mid-table 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.
"The online platform providing access to clinical trials in Romania is the Health Innovation Hub's first major project milestone. It serves as both an information and educational tool. We aim to support the development of a competitive model for clinical trials in Romania, offering patients the opportunity to make informed decisions and access advanced therapeutic options. Of course, the decision to enrol a patient in a trial belongs solely to the patient and the treating physician, in accordance with inclusion and exclusion criteria and clinical evaluation. We hope this platform will strengthen public trust and support the development of a predictable, efficient medical research framework focused on real patient needs," said ANMDMR president Razvan Mihai Prisada, project coordinator.
Secretary of State at the Ministry of Health Claudiu Damian highlighted that the development of research is essential for the future of Romanian medicine.
"The most concrete expression of this development is clinical trials with human medicines, 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 and innovative therapies under the same conditions as patients in any other EU member state. It is an opportunity for modern treatment, rigorous monitoring, and international quality standards," Damian said.
According to Alexandru Rafila, Chair of the Committee for Health and Family in the Chamber of Deputies, "teamwork and multi-sector collaboration made the difference in the case of the Innovation Hub," while approval of the national strategy and legislative changes have tripled the number of clinical trials and patient access to innovative medicines over the past year.
According to Viorel Jinga, Rector of the Carol Davila University of Medicine and Pharmacy in Bucharest, "transparency in clinical trials is essential to rebuilding public trust in research, (...) at the same time, the platform will be a valuable tool for researchers and universities."
Radu Iliescu, Vice-Rector of Grigore T. Popa University of Medicine in Iasi, added that "if we want medicine in Romania to be truly evidence-based, Romanian clinicians must not only be consumers of scientific information but also generators of it."
Frank Loeffler, President of the Local American Working Group (LAWG), stated that the new national platform adds transparency to clinical research in Romania.
Patient representatives also welcomed the platform launch, including Rozalina Lapadatu, President of the Association of Patients with Autoimmune Diseases (APAA), and Luminita Valcea, Executive Director of the Coalition of Patient Organisations with Chronic Conditions (COPAC), highlighting its importance.
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