Romania is underrepresented in oncological clinical trials, despite the scale of cancer and one of the highest mortality rates in Europe, according to a report published on Tuesday by the European Society for Medical Oncology (ESMO), in the context of implementing the next stages of Europe's Beating Cancer Plan. The report was presented in Brussels, at the European Parliament, during an event hosted by MEP Romana Jerkovic, Vice-Chair of the Committee on Public Health.

The report highlights a major imbalance between medical needs and access to innovation. Clinical research is concentrated more in countries with stronger economic resources than in those with high incidence and mortality rates, while surprising disparities show that some Western European economies lag behind, whereas regions in northern and southern Europe lead in terms of access to trials.

The analysis is based on the Trial Density Ratio (TDR), which measures the number of clinical trials per 100,000 inhabitants, as well as data from 34 countries for the period 2019-2024. Trials were classified by phase (I, II and III) and compared with datasets from Eurostat and the World Health Organization.

In Romania's case, the data indicate a pronounced mismatch between the cancer burden and access to clinical research. In 2022, the country recorded 88,681 new cancer cases and 47,884 deaths, with a standardised mortality rate of 126.1 per 100,000 inhabitants - the third highest in Europe, after Hungary and Poland. However, during the analysed period, Romania accounted for only 1.7% of all oncological clinical trial entities in Europe (169 out of 9,885), while trial density stands at 0.88 per 100,000 inhabitants - the lowest in Eastern Europe.

In addition, the distribution of trials shows a predominance of late-phase studies: 76.9% are phase II/III and III trials, while only 23.1% are early-phase studies (I, I/II, II), indicating limited access to early innovation. The TDR is 0.5, below the 0.8-1.2 range considered adequate, placing Romania among underrepresented countries relative to its population.

The socio-economic context contributes to this situation: the Human Development Index (HDI) stands at 0.83, below the European average, disposable income per capita is 18,396 euro, and expenditure on research and development in the pharmaceutical industry amounts to only 110 million euro, far below levels in Western and Northern Europe. The degree of urbanisation is also relatively low (30.4%), while social protection expenditure accounts for 16.4% of GDP. All these factors correlate with the low level of clinical research activity.

Overall, Romania combines a moderate to high cancer incidence, very high mortality, low clinical trial density and underrepresentation in their distribution, indicating a high level of unmet medical needs.

At European level, the ESMO report confirms an uneven distribution of clinical trials, with significant regional differences. Belgium (5.77 trials per 100,000 inhabitants), Denmark (2.8) and Spain (1.6) are among the top-ranked countries, while major economies such as Germany (TDR 0.5) and the United Kingdom (0.6) are also considered underrepresented. In South-Eastern Europe, several states, including Albania, Montenegro and North Macedonia, have minimal levels of activity.

The analysis shows that clinical trial density is positively correlated with cancer incidence, but also with favourable socio-economic indicators such as higher income, higher levels of human development and greater social protection spending. By contrast, there is no direct correlation between the volume of trials and cancer mortality, suggesting that research resources are not directed towards areas with the highest death rates.

The report concludes that, in Europe, oncological clinical research activity is more closely linked to economic development and investment in healthcare than to real need driven by cancer mortality, raising major issues of equity in access to innovative treatments.

Europe's Beating Cancer Plan, a long-term framework strategy integrated into EU health policies, was launched in 2021 as part of the European Health Union and covers the entire disease pathway - from prevention and early detection to treatment and patients' quality of life. Funding of 4 billion euro is allocated from various programmes, including EU4Health, to support member states in tackling this disease. AGERPRES (RO - writing by: Mariana Ionescu; EN - writing by: Adina Panaitescu)