Cancer Clinical Trials in Europe: 50% Drop & China’s Rise
Rome, – Cancer research in Europe is facing a significant crisis, with clinical trials declining by 50% over the past decade. Data released today reveals a marked shift in the global landscape of oncology research, as China rapidly emerges as a dominant force whereas the United States also experiences a reduction in trials.
In , European trials accounted for 18% of all cancer studies worldwide. By , that figure had fallen to just 9%, according to figures presented at the ‘Clinical Research Course’ in Rome, organized by the Italian Association of Medical Oncology (AIOM) in collaboration with the American Society of Clinical Oncology (ASCO). The United States has seen a 34% decrease in clinical trials over the same period, dropping from 26% to 17% of global studies.
Conversely, China has experienced a dramatic increase in cancer research activity, rising from 8% of global trials in to 29% in . This shift reflects changing geopolitical dynamics and a growing investment in scientific research within the Asian nation.
The decline in European research is further underscored by a decrease in patient enrollment. Approximately 60,000 fewer patients participated in clinical trials between and , falling from 286,159 to 226,155, AIOM data shows.
Several factors contribute to this crisis, according to experts. Lengthy approval times for trials make European countries less attractive to pharmaceutical companies. A decline in Phase 1 studies – the earliest stage of testing in humans – and a lack of dedicated resources and personnel are also significant issues. Regulatory complexity, particularly with the introduction of the Clinical Trials Regulation, has further hampered progress.
“China is becoming the first country in the world for the number of clinical trials initiated and for patients enrolled,” explained Massimo Di Maio, President of AIOM. “In Europe, the introduction of regulations like the Clinical Trials Regulation has increased regulatory complexity, making the process of approval and initiation of trials more tough and slow.”
Beyond the logistical challenges, concerns are also being raised about the focus of cancer research. Less than 40% of clinical trials that led to the approval of new cancer therapies between and included an assessment of patients’ quality of life. Experts are now calling for quality of life to be a primary or secondary endpoint in cancer trials.
“For patients with advanced disease, quality of life is the most tangible measure of the value of care,” Di Maio stated. “Patient-reported outcomes provide the patient’s perspective on the impact of symptoms and cancer treatments, complementing conventional measures of efficacy and toxicity assessed by researchers.”
Researchers emphasize the importance of identifying dominant symptoms for each type of cancer and establishing how symptom relief impacts daily activities. For example, shortness of breath in lung cancer, abdominal pain in gastrointestinal or gynecological cancers, and bone pain in prostate cancer are key areas for assessment.
The situation demands a comprehensive response, according to Rossana Berardi, President-elect of AIOM. “If we want Europe and Italy to return to being leaders in the development of innovative cancer therapies, We see necessary to simplify and speed up the authorization processes for clinical trials, reducing the bureaucratic obstacles that today slow down the start of the trials and make our countries less attractive for international research.”
Berardi also highlighted the need for investment in skilled professionals dedicated to clinical research, such as research coordinators, data managers, and support staff. “These are essential elements to guarantee quality, efficiency and sustainability to the studies,” she said.
Francesco Perrone, President of the AIOM Foundation, underscored the importance of defining appropriate endpoints for research questions. While overall survival and quality of life are considered the most relevant endpoints, progression-free survival is often chosen as a primary objective, even in situations where its validity is limited. In such cases, data on quality of life becomes crucial for a comprehensive clinical evaluation.
“The absence of results on quality of life prevents the scientific community from making a complete assessment of the value of innovative therapies,” Di Maio concluded. “their inclusion in the main presentation and publication is fundamental. It is important that scientific societies provide training on these issues and create opportunities for discussion, so that clinicians are increasingly aware of the importance of adopting these tools.”
The data presented today paints a concerning picture for cancer research in Europe, signaling a need for urgent action to reverse the decline and ensure continued progress in the fight against the disease. The shift in global research leadership towards China underscores the importance of adapting to changing geopolitical realities and prioritizing innovation in oncology.