The number of clinical trials conducted in Romania has tripled in recent years, but remains several times lower than other European countries
In Romania, 3,591 clinical trials are currently being conducted, compared to France, with 41,582, Great Britain with 28,220 or Belgium with 14,883, a country with a considerably smaller population. Worldwide there are 581,764 clinical trials now taking place, of which 290,188 are taking place in Europe.
Clinical trials – in which the efficacy and safety of a drug are tested for use in humans – are often the only chance for patients who have exhausted treatment methods.
The President of the National Agency for Medicines and Medical Devices, Răzvan Prisada, says, however, that at the end of 2024 and in the first half of 2025, Romania recorded the highest percentage increase in the number of clinical trials in the European Union: their number tripled compared to the level before the pandemic.
“Romania is now with its foot on the accelerator. We have no more excuses,” said the president of the Medicines Agency during the Impact conference, dedicated to clinical trials, attended by representatives of over 40 patient associations from our country.
The clinical trials sector is the most regulated field in the pharmaceutical industry, and Romanian legislation is aligned with European and American standards, assured Răzvan Prisada: “Safety is the most important. If the study is not safe, we stop.”
Present at the conference, Prof. Dr. Anca Streinu-Cercel, a doctor at the “Prof. Dr. Matei Balș” National Institute of Infectious Diseases, dismantled one of the most common myths related to terminology: “I prefer not to use the word study, because it can create a barrier. I call it research, protocol, access to therapies. Study should be a word that we like, not scare us.”
Prof. Dr. Doina Drăgănescu, President of the National Commission for Bioethics of Medicines and Medical Devices, explained the mechanism behind entering a clinical trial: “Informed consent is not something you just tick off. It can take several weeks of consultations between the patient, doctor and family. We ensure that the patient benefits from the best conditions and is constantly monitored.”
“Don't let your fears decide for you”
Doina Persecan, a patient diagnosed with severe alopecia areata and total hair loss, participated in a clinical study with doctor Ioana Vescan. Her message to conference attendees was, “Don't let your fears decide for you.”
Her doctor, Ioana Vescan, added: “At each monthly visit, Doina grew a few hairs. She told me she was happy because she could feel the wind in her hair again when she walked down the street.”
Diana Budacă, diagnosed with Sjögren's Syndrome, described how participating in a clinical trial changed her quality of life: “Now I can enjoy being with my family.”
Doctors Ileana Stoicescu and Mădălina Vasile detailed three categories of benefits that participation in a clinical trial brings: personal and medical benefits (access to new treatments, careful monitoring and additional consultations), financial and logistical benefits (free medication and investigations, reimbursement of transport, possible compensation for dedicated time) and social and future benefits (contribution to the progress of medicine and support for future patients).
“The clinical trial patient is not just a research participant, but a patient receiving the best medical care available,” the two doctors say.
