Scientific and Medical Division Fellow, European Society for Medical Oncology (ESMO)
Clinical trials are our best tool to improve cancer care for patients through testing the clinical value of a new treatment or intervention. However, eligibility criteria are overly restrictive.
One year ago, the approval of the first COVID-19 vaccine was fuelling debate in the oncology community about whether it was safe or efficacious to immunise patients with cancer. Patients under immunosuppressive anticancer treatment were excluded from vaccine trials despite their increased risk of severe infection or death from COVID-19. Whereas further research confirmed the safety and efficacy profile of vaccines also for people with cancer, questions were raised about overly restrictive eligibility criteria in clinical research.
In a recent editorial on ESMO Open, the European Society for Medical Oncology (ESMO) launched a discussion on how to innovate clinical research to facilitate equitable access to clinical trials of real-world populations in a pragmatic, simplified and methodologically robust way for the benefit of all our patients.
Oncologists need to find innovative ways to be more inclusive without affecting the quality of research.
Diversifying patient involvement in clinical trials
Engagement of patient populations in research is essential to tackle the diversity of cancer as a complex disease and inform a patient-centered approach in cancer care.
Before the pandemic, the restrictive eligibility criteria and under-representation of the real-world population were already considered potential deficits in cancer research. For instance, some immunotherapy trials historically excluded elderly patients, those with auto-immune diseases, patients with HIV, or those treated with corticosteroids, despite these groups representing a significant proportion of people with cancer.
Changing eligibility criteria
Oncologists need to find innovative ways to be more inclusive without affecting the quality of research. Instead of exclusions due to age or the presence of certain comorbidities, clinically relevant and valid tools with pre-defined but not very restrictive thresholds assessing frailty or disease severity should be used more to identify patients who can be included on a case-by-case basis.“In the midst of every crisis, lies great opportunity,” said Albert Einstein. The COVID-19 pandemic is a dramatic and negative experience. However, lessons learnt could be taken further to increase access to clinical trials for the benefit of all our patients.