In 10 years, clinical trials in oncology started in Europe have practically halved, in terms of comparison with other areas of the world. In 2013, European trials constituted 18% worldwide, falling to 9% in 2023. The trend is common between the Old Continent and the United States, where a reduction of 34% was recorded (from 26% to 17%).
New geopolitical balances are changing the geography of scientific research against cancer and see China as an increasingly protagonist. From 2013 to 2023, the Asian country showed a clear increase in trials, from 8% to 29%. The crisis in European research is also demonstrated by the decline in patients enrolled, 60 thousand fewer in 5 years (from 286,159 in 2018 to 226,155 in 2023).
Overtaking China
There are several reasons for this trend. First of all, approval times that are too long certainly count, making European countries unattractive for pharmaceutical companies. But the progressive decline of phase I studies, those that begin the process of testing a drug, is also important, leading to the lack of resources and dedicated personnel.
To reverse this negative trend, a change of pace is needed. Not just in economic terms anymore. There is also a need to redefine the design of the trials. In fact, less than 40% of clinical trials against cancer, which have 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 tumor trials comes from the experts gathered in the “Clinical Research Course”, the course, now in its fourth edition, held in Rome, organized by the Italian Association of Medical Oncology (AIOM) in collaboration with the American Society of Clinical Oncology (ASCO).
“China is becoming the first country in the world in terms of number of clinical trials launched and patients enrolled. In Europe, the introduction of rules such as the Clinical Trials Regulation has increased regulatory complexity, making the process of approving and starting trials more difficult and slower”
explains Massimo Di Maio, President of AIOM.
Due to these delays, European countries have become less competitive globally, not to mention the lack of personnel. In particular, in Italy clinical research coordinators still lack real legal recognition. To give a new impetus to cancer studies, it is also necessary to guarantee more space for quality of life. The scientific community considers it an increasingly important parameter, but its adoption among the main outcomes of tumor trials and the communication of this type of results are not yet sufficient.
Furthermore, according to experts, clinical research is also a question of health policy and the competitiveness of the country’s system. For Europe and Italy, it is necessary to simplify and speed up the authorization processes for clinical trials, reducing the bureaucratic obstacles that currently slow down the start of trials and make our countries less attractive for international research. All this by investing in the skills and stabilization of professional figures dedicated to clinical research, such as research coordinators, data managers and support staff, who represent an essential element for guaranteeing quality, efficiency and sustainability of studies.
Consider patients’ opinions more
In an article published in “Lancet Oncology”scientists and patient representatives gathered in the initiative “Common Sense Oncology” and the European Organization for Research and Treatment of Cancer (EORTC) recommend 14 fundamental 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. Furthermore, quality of life results must be included in the main presentation and publication of the study.
“In 2025, in Italy, approximately 390,000 new cancer diagnoses were estimated, in the United States in 2026 over 2.1 million. For people affected by advanced disease, quality of life is the most tangible measure of the value of treatment. The PROs, Patient-Reported Outcomes, provide the patient’s perspective on the impact of oncological symptoms and treatments, implementing with a subjective point of view the conventional measures of efficacy and toxicity assessed by researchers”
Di Maio says.
An important aspect highlighted in the study published in ‘Lancet Oncology’ concerns the preliminary definition of the dominant symptoms in each tumor. Examples are shortness of breath in lung cancer, abdominal pain in gastrointestinal or gynecological cancers, and bone pain in prostate cancer. You also need to determine how symptom relief affects your daily activities.
