Cancer, clinical trials launched in Europe halved in 10 years and China takes the scene

The crisis in the EU is also evidenced by the drop in patient enrolment of -60,000 in 5 years due to excessively long approval times that discourage pharmaceutical companies, lack of resources and personnel

by Health Review

20 March 2026

4' min read

Translated by AI

Versione italiana

4' min read

Translated by AI

Versione italiana

In 10 years, cancer clinical trials initiated in Europe have decreased by 50%. In 2013, European trials made up 18% worldwide, falling to 9% in 2023. A trend that unites the Old Continent with the United States, where there has been a 34% reduction (from 26% to 17%). New geopolitical balances are changing the geography of scientific research against cancer, with China playing an increasingly prominent role.

Needed to change pace

From 2013 to 2023, the Asian country showed a sharp increase in trials, from 8% to 29%. The crisis in European research is also evidenced by the decline in the number of patients enrolled, 60,000 fewer in five years (from 286,159 in 2018 to 226,155 in 2023). There are several reasons for this: from the excessively long approval times, which make European countries unattractive to pharmaceutical companies, to the decline in phase I studies, to the lack of resources and dedicated personnel. To reverse this negative trend, a change of pace is needed. Not only more investment, but also a redefinition of the design of trials. In fact, less than 40 per cent of cancer clinical trials, which led to the approval of therapies in 10 years (2012-2021), report an improvement in patients' quality of life. The request to include this parameter among the main outcomes (primary or secondary endpoint) of cancer trials comes from the experts gathered at the 'Clinical Research Course', the course, now in its fourth edition, which opens today in Rome, organised by the Italian Association of Medical Oncology (AIOM) in collaboration with the American Society of Clinical Oncology (Asco).

Italy and China in the Mirror

'China is becoming the first country in the world in terms of the number of clinical trials initiated and patients enrolled,' explains Massimo Di Maio, President of Aiom. In Europe, the introduction of regulations such as the Clinical Trials Regulation has increased regulatory complexity, making the process of approving and starting trials more difficult and slower. Because of these delays, European countries have become less competitive globally, not to mention the lack of personnel. In particular, clinical research coordinators in Italia still lack real legal recognition. In order to give new impetus to cancer studies, it is also necessary to give more space to quality of life. The scientific community regards it as an increasingly important parameter, but its adoption among the main outcomes of cancer trials and the communication of such results are still not sufficient'.

The 14 Principles

In an article published in 'Lancet Oncology', scientists and patient representatives united in the 'Common Sense Oncology' initiative and the European Organisation for Research and Treatment of Cancer (Eortc) recommend 14 basic principles. The most relevant: patients must be involved in the development of the study protocol and the assessment of health-related quality of life must be the primary or secondary outcome of the research. Questionnaires used to assess quality of life must be completed by patients before the start of treatment, at predefined time intervals (every 3-4 weeks) and for a period after the end of treatment. In addition, the results on quality of life must be included in the main presentation and publication of the study.

Focus on quality of life

'In Italy in 2025, an estimated 390,000 new cancer diagnoses will be made, in the US in 2026 over 2.1 million,' the Aiom President continues. For people with advanced disease, quality of life is the most tangible measure of the value of treatment. Pro, Patient-Reported Outcomes, provide the patient's perspective on the impact of cancer symptoms and treatments, implementing the conventional measures of efficacy and toxicity assessed by researchers with a subjective point of view. An important aspect highlighted in the study published in 'Lancet Oncology' concerns the preliminary definition of the dominant symptoms in each tumour. Examples are shortness of breath in lung cancer, abdominal pain in gastrointestinal or gynaecological cancers, and bone pain in prostate cancer. It is also necessary to establish how symptom relief affects daily activities'.

The mantra: simplify and speed up

"Clinical research is also a matter of health policy and the competitiveness of the country's system," says Rossana Berardi, President-elect of Aiom. "If we want Europe and Italia to take the lead again in the development of innovative cancer therapies, it is necessary to simplify and speed up the authorisation processes for clinical trials, reducing the bureaucratic obstacles that currently slow down the start of trials and make our countries less attractive to international research. At the same time, it is essential to invest in the skills and stabilisation of professional figures dedicated to clinical research, such as research coordinators, data managers and support staff, who are an essential element in ensuring the quality, efficiency and sustainability of studies. In this scenario, initiatives such as the 'Clinical Research Course' promoted by Aiom and Asco are particularly important because training research professionals means strengthening the entire system of innovation in oncology and ensuring that patients have faster and fairer access to new therapeutic opportunities"

Redefine Endpoints

'Defining appropriate endpoints for research questions and disease contexts is a crucial step in study design, leading to a methodologically correct structure of the primary hypothesis and, thus, to an adequate assessment of the benefit of the experimental therapy,' stresses Francesco Perrone, President of the Aiom Foundation. Overall survival and quality of life are considered the most relevant endpoints in oncology clinical trials. Despite the well-known limitations of progression-free survival, this parameter is chosen as the primary endpoint with a frequency similar to overall survival in trials involving patients with advanced disease. That is, there is a tendency to choose progression-free survival as the primary endpoint, even in settings where it is not fully validated. In these cases, the availability of quality-of-life data assumes a complementary and significant role, allowing a correct interpretation of the clinical relevance of the experimental drug'.

'The absence of results on quality of life prevents the scientific community from making a full assessment of the value of innovative therapies,' Massimo Di Maio concludes. 'This is why their inclusion in the main presentation and publication are essential. It is important for scientific societies to provide training on these issues and create opportunities for discussion, so that the awareness of the importance of adopting these tools increases among clinicians'.