Considerations for Using Clinical Practice Data to Study COVID-19 Vaccines in Patients With Cancer
Ce dossier présente un ensemble d'articles concernant la pandémie de COVID-19 et la vaccination contre la COVID-19 chez des patients atteints d'un cancer
Phase 3 randomized clinical trials (RCTs) remain the established benchmark for evaluating vaccines and other preventive strategies. However, their restrictive eligibility criteria, designed to enhance internal validity and participant safety, often exclude individuals with major comorbidities or immunosuppression. By focusing on relatively healthy participants, RCTs demonstrate efficacy under controlled conditions to facilitate regulatory approval, typically starting with groups at lower risk for complications before expanding to more complex populations. Yet this approach limits external validity. During the COVID-19 pandemic, for instance, pivotal vaccine clinical trials excluded individuals with cancer,1,2 despite their heightened vulnerability and risk of severe outcomes.
JAMA Oncology , éditorial, 2025