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The emergence of the precision medicine paradigm in oncology has led to increasing interest in the integration of real-world data (RWD) into cancer clinical research. As sources of real-world evidence (RWE), such data could potentially help address the uncertainties that surround the adoption of novel anticancer therapies into the clinic following their investigation in clinical trials. At present, RWE-generating studies which investigate antitumour interventions seem to primarily focus on collecting and analysing observational RWD, typically forgoing the use of randomisation despite its methodological benefits. This is appropriate in situations where randomised controlled trials (RCTs) are not feasible and non-randomised RWD analyses can offer valuable insights. Nevertheless, depending on how they are designed, RCTs have the potential to produce strong and actionable RWE themselves. The choice of which methodology to employ for RWD studies should be guided by the nature of the research question they are intended to answer. Here, we attempt to define some of the questions that do not necessarily require the conduct of RCTs. Moreover, we outline the strategy of the European Organisation for Research and Treatment of Cancer (EORTC) to contribute to the generation of robust and high-quality RWE by prioritising the execution of pragmatic trials and studies set up according to the trials-within-cohorts approach. If treatment allocation cannot be left up to random chance due to practical or ethical concerns, the EORTC will consider undertaking observational RWD research based on the target trial principle. New EORTC-sponsored RCTs may also feature concurrent prospective cohorts composed of off-trial patients. ispartof: EUROPEAN JOURNAL OF CANCER vol:186 pages:52-61 ispartof: location:England status: published

Background: In this study, we aimed to investigate the specific-antibody response to the COVID-19 vaccination and the immunophenotyping of T cells in older adults who were engaged or not in an exercise training program before the pandemic. Methods: Ninety-three aged individuals (aged between 60 and 85 years) were separated into 3 groups: practitioners of physical exercise vaccinated with CoronaVac (PE-Co, n = 46), or vaccinated with ChadOx-1 (PE-Ch, n = 23), and non-practitioners vaccinated with ChadOx-1 (NPE-Ch, n = 24). Blood samples were collected before (pre) and 30 days after vaccination with the second vaccine dose. Results. Higher IgG levels and immunogenicity were found in the PE-Ch and NPE-Ch groups, whereas increased IgA levels were found only in the PE-Ch group post-vaccination. The PE-Co group showed a positive correlation between the IgA and IgG values, and lower IgG levels post-vaccination were associated with age. Significant alterations in the percentage of naive (CD28+CD57-), double-positive (CD28+CD57+), and senescent (CD28-CD57+) CD4+ T and CD8+ T cells were found post-vaccination, particularly in the PE-Ch group. Conclusions: The volunteers vaccinated with the ChadOx-1 presented not only a better antibody response but also a significant modulation in the percentage of T cell profiles, mainly in the previously exercised group.